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  Table of Contents  
Year : 2022  |  Volume : 59  |  Issue : 2  |  Page : 159-169

Oral and dental care before radiotherapy: Guidelines and development of a time-bound protocol

1 Unit of Prosthodontics, Oral Health Sciences Centre, Postgraduate Institute of Medical Education and Research, Chandigarh, India
2 Department of Radiotherapy, Postgraduate Institute of Medical Education and Research, Chandigarh, India

Date of Submission03-Aug-2020
Date of Decision22-Sep-2020
Date of Acceptance02-Dec-2020
Date of Web Publication08-Aug-2022

Correspondence Address:
Sudhir Bhandari
Unit of Prosthodontics, Oral Health Sciences Centre, Postgraduate Institute of Medical Education and Research, Chandigarh
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/ijc.IJC_871_20

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 » Abstract 

Involvement of multidisciplinary team is the mainstay in the holistic treatment outcome in head and neck cancer patients. Achieving a state of oral health is regarded as an essential treatment goal before radiation therapy but, it may get overlooked due to many competing priorities, lack of multidisciplinary facilities and/or incoordination, and limited overall awareness with regards to means of achieving oral health and in a time-bound manner and its relevance in improving quality of life in cancer survivors. Radiation inflicts an immense amount of damage upon the entire maxillofacial complex and consequently oral treatment after radiotherapy may remain untreated and/or undertreated. It is, therefore, vital to eliminate oral foci of infections well within a time frame before radiation so that tumor prognosis is not compromised.This article describes the current guidelines combined with a time-bound protocol developed in our center to not only prepare a patient for conventional radiotherapy but also to provide a logical perspective towards the feasibility of the oral rehabilitation post-cancer cure. The protocol aims to maximize the quality of life in head and neck cancer survivors by; patient education, minimizing preventable oral complications, and retaining strategic teeth for function, aesthetics, speech, and prosthetic support. The time-bound pre-radiation oral care protocol is rational, achievable, and is aligned towards the sustained oral health care goals in head and neck cancer patients and can be utilized as a useful resource in multidisciplinary head and neck cancer care facilities.

Keywords: Head and neck cancer, oral health, prosthesis, radiotherapy

How to cite this article:
Bhandari S, Soni BW, Jamwal A, Ghoshal S. Oral and dental care before radiotherapy: Guidelines and development of a time-bound protocol. Indian J Cancer 2022;59:159-69

How to cite this URL:
Bhandari S, Soni BW, Jamwal A, Ghoshal S. Oral and dental care before radiotherapy: Guidelines and development of a time-bound protocol. Indian J Cancer [serial online] 2022 [cited 2022 Dec 3];59:159-69. Available from:

 » Introduction Top

Radiotherapy (RT) is a predominant factor in determining the oral health-related quality of life (OHRQOL) after head and neck cancer (HNC) treatment.[1] Multiple, inevitable, and overlapping side effects of HNC treatment severely impacts the origin and progression of oral diseases, increases the frequency of hospital visits, limits the feasibility of gaining optimal oral care, presents severe constraints in rendering the oral treatment, increases the probability of treatment failures, leads to redundancy in social lifestyle due to functional and facial impairments thereby, causing depression and increase in suicide rates amongst HNC patients.[2],[3],[4]

The oro-dental changes consequent to RT are due to the amalgamation of multiple factors which include direct damage to both hard and soft tissues, damage to salivary glands, difficulty in maintaining oral hygiene due to mucositis induced pain and trismus, leading to radiation caries (RC), periodontal breakdown, and osteoradionecrosis (ORN).[5],[6] Many oral diseases requiring surgical intervention remain untreated and/or under-treated after RT due to the fear of ORN, consequently, restricting dental treatment to palliation. Although, oral rehabilitation in HNC patients has shown improvement in function and appearance, the quality of life scores were found to be inferior in irradiated patients compared to non-irradiated patients.[7],[8],[9]

There is a consensus on identifying and removing underlying risk factors for poor dental outcomes before initiating RT.[10],[11],[12],[13],[14],[15],[16],[17],[18],[19],[20],[21],[22],[23],[24],[25] The aims of pre-treatment oral care regime is to mitigate acute flaring of oral infection during RT so as to prevent interruption in the treatment schedule of the primary disease, achieve an overall oral environment conducive to address oral complaints, and decrease the need for extensive dental treatment and subsequent complications in cancer survivors.

Lack of health care facilities with dedicated multidisciplinary team, incoordination between the team members due to lack of established oral care protocol, and paucity of time required to deal with all present and potential oral foci of infection before RT has always been a source of distress to the treating oncologist and the dental team. Understandably, the time involved in addressing all indicated oral issues will delay the treatment of the primary pathology and constitute a significant reason for growing anxiety in already agonized patients and their relatives. Numerous articles have described oral care before RT, but to date, there is no established time-bound protocol and/or sequence of oral treatment strategies directed towards achieving a satisfactory oral health pre-RT. In this article, we describe a time-bound, attainable, and logical sequencing of preventive strategies we follow at our center for preparing patients for conventional RT, with a perspective towards the feasibility of a prosthesis post-cancer cure.

 » Protocol and Timeline Top

The time-bound protocol detailed in this article is based on the values of preventing oral health-related adverse outcomes in HNC patients undergoing RT, achieve an optimum state of oral health to endure trauma from radiation and to minimize dental issues which usually remain unaddressed after RT. The protocol is aligned towards maximizing the OHRQOL in cancer survivors by creating awareness through education, minimizing preventable oral complications, retaining strategic teeth for function, aesthetics, speech, and prosthetic support [Figure 1].
Figure 1: The oral care protocol, timeline, and sequencing for preparing head and neck cancer (HNC) patients for radiotherapy (RT). The earliest one may clear patients for RT with a full complement of teeth and extraction of only third molars is 17–18 days (Blue line). Ignoring treatment for outliers, maximum time required to clear a patient for RT is 22–23 days (Yellow line)

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Patient Education: Day 1

This is the patients' first visit to the oral health care facility after the diagnosis of HNC and before the scheduled treatment. Patient and family education on the side effects of RT, the rationale of oral care before RT, and its life-long maintenance is an integral element in the success of the oral supportive care program in HNC patients.[6],[7],[10],[11],[12],[13],[14],[15],[16],[17],[18],[19],[20],[21],[22],[23],[24],[25] The intent is to motivate the patients and make them believe in the prevention of future dental complications by removing the present and potential oral foci of infection before RT. However, research has shown persisting gaps in the knowledge on the type, timing, and the team that provides the education.[26]

In our center, patients are apprised of the impact of RT on dental structures, type and extent of oral complications, respective preventive and therapeutic strategies, and maintenance of oral and oro-pharyngeal function throughout their survivorship. The necessity of oral hygiene maintenance, periodontal therapy, extractions, restorative procedures, masticatory muscle exercises (MME), increased treatment needs a post-cancer cure, prevention of RC, and significance of follow-ups are duly emphasized at this stage.[27] A simple language for communication and photographs showing side effects of RT are essential tools for easier comprehension. It is crucial to alleviate patients' apprehensions regarding the relevance of dental procedures before starting RT, as it ensures their commitment towards the cause and encourages active participation.

Nutritional Counseling: Day 1

RT causes weakness, lethargy, lack of motivation, susceptibility to infection, and compromise the masticatory efficiency leading to nutritional deficiency and weight loss.[28],[29] Nutritional counseling, dietary instructions, and nutritional support positively influence treatment outcomes, maintain general health, minimize weight loss, and rule out nasogastric feeding in HNC patients.[29],[30] Nutritional counseling in the oral healthcare setting is primarily related to the prevention of RC and oral hygiene maintenance.[5],[31] HNC patients are encouraged to increase their fluid intake, eat moistened foods at room temperature, increase the frequency of their food intake if their appetite is reduced, and high-calorie nutrition supplements are advised to be taken along with meals. The food items contributing to mucosal irritation are strongly discouraged.

Masticatory muscle exercises: Day 1

The rationale for implementing MME is to achieve and/or sustain sufficient mouth opening conducive for routine oral functions, oral hygiene maintenance, evaluation of tumor site for recurrence, and obtain comfortable access to the dental treatment sites. For standardizing the clinical recordings, we consider a mouth opening ≤35 mm as trismus.[32] Due to variable and conflicting evidence on the effect of MME regimen on the improvement in mouth opening in HNC patients, no clinical recommendations were made in a systemic review regarding the intensity and frequency of MME's for the treatment of trismus.[33],[34],[35],[36],[37]

Considering the peculiarities of the patients (lower literacy, poor socioeconomic status, lack of motivation, and poor access to oral health care settings) we receive in our center; we encourage all HNC patients to incorporate the suggested MME as a part of their routine before, during, and after RT. Demonstration to form two stacks (one for each side) of flat wooden spatulas (ice-cream sticks/tongue blades) according to the individual limits of mouth opening is given to the patients. The wooden spatulas are held together with an elastic band to increase or decrease the height of the stack(s) as the need be. Patients are advised to place them bilaterally in their mouth (premolar-molar region) 5–6 times a day for a maximum of 3–5 min each time.

The exercise routine is individualized and dynamic. The severity of trismus, pain, and discomfort are the deciding parameters to vary the height of the wooden stack, intensity of exercises, holding time, and frequency during the day. Reversing trismus and maintenance of improved mouth opening is a difficult and slow process and relies heavily on patients' compliance with the instructions and resolve to achieve success in treatment.

Follow-up schedule: Day 1

Oral care begins at the diagnosis stage of HNC and requires active intervention throughout the patients' survivorship [Figure 2]. A life-long follow-up aids in promoting health and minimizing long-term adverse outcomes by; encouraging patients to adhere to the instructions, assess the disease progression, timely identification, and correction of latent and/or asymptomatic oral diseases, and evaluate and reinforce the oral hygiene routine. Considering poor compliance in HNC patients and the need for individualized care, we encourage patients to maintain a 3-month follow-up visit.[38],[39] Their dental visit is combined with their oncology follow-up appointment to improve compliance and reduce the recurring economic burden on them.[40],[41]
Figure 2: The scope of oral care in HNC patients. Day 1 is the patients' first visit to the oral health care facility after diagnosis of the disease has been made irrespective of the treatment pathway. Red Flags are alert for the concerned team of dentists to address patients' oral issues before surgery and/or RT and post-treatment cancer cure

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Prosthodontic considerations: Day 1

After the completion of RT, the denture-bearing mucosa becomes fragile and may easily ulcerate and bleed due to functional load-bearing and friction related to the removable prosthesis. HNC patients with a fully functional and acceptable pre-existing removable prosthesis are advised for its intermittent use, limited to meals and social interactions. Wearing a prosthesis at night is strongly discouraged. Patients are counseled to maintain a clean prosthesis and immediately consult a dentist in the event of denture-related injury during and after RT.[42] The use of soft liner to improve the fit of the prosthesis is discouraged due to its porous nature, increased propensity towards the accumulation of debris, and Candida infection after RT.[16],[23],[43]

Fixed partial dentures (FPDs) are evaluated for the prevailing complaints and for any un-correctable errors, which may increase the risk of complications during and/or after RT. All defective FPDs are planned for removal before beginning extractions to ascertain the status of abutments. Abutments with non-restorable secondary caries, root caries, persistent periapical infections, fractures, and compromised attachment apparatus are considered for extraction. A panoramic radiograph is a must for all patients before committing to an oral treatment plan. It assists in assessing the peri-apical and periodontal health of the teeth; quickly identify persisting and/or potential foci of infection, the extent of the treatment required, and patient education [Figure 3].
Figure 3: Panoramic radiographs before RT. (a), defective prosthesis demanding removal and critical evaluation of abutments for extraction or retention (b), deeply impacted canine in a middle-aged patient not to be attempted for removal (Arrow) (c), all second and third molars to be extracted before RT

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The prosthodontic component of the protocol is based on the philosophy of the shortened dental arch (SDA), which aims to maintain occluding units until the first molars. In HNC patients, SDA specifically merits in achieving all-around access for professional and personal dental care, long term occlusal stability without compromising the masticatory efficiency.[44]

Bearing the future prosthesis design in mind, the decision to retain or extract a tooth is based on the following parameters:

  1. The strategic value: A healthy tooth that may serve as an abutment to a fixed and/or removable prosthesis and act as an occlusal supporting unit is retained. The retained tooth must be accessible to professional and personnel care over time.
  2. In patients with only a few salvageable anterior teeth, a complete overdenture (OVD) is preferred over a complete denture (CD) or a removable partial denture (RPD). A conventional CD leads to progressive atrophy of the bony foundation and may not be adequately retentive due to RT led salivary changes.[45] In comparison to a CD, root supported OVD provides better retention and stability, preserves bone around teeth, and maintain proprioception for better jaw co-ordination during chewing.[46] RPD is the least preferred option in a precarious oral environment after RT; as the probability of an abutment fracture in a clasp retained RPD is high, and atraumatic extraction of such abutments is difficult and predisposes the patients to ORN.[47],[48]

Orthodontic Considerations: Day 1

There is limited information available with regards to orthodontic treatment recommendations for cancer patients.[49] It is advisable that young HNC patients requiring comprehensive orthodontic treatment should undertake consultation, to identify teeth requiring extractions for the sake of correction of malocclusion after cancer cure. In patients with deep bite, it is prudent to use a soft splint to prevent trauma from occlusion until comprehensive orthodontic treatment is started after RT [Figure 4].
Figure 4: (a), A young HNC patient would require comprehensive orthodontic treatment after RT (b), orthopantomogram of the same patient showing the sub-optimal plane of occlusion, misaligned, and impacted teeth. Teeth requiring extractions for orthodontic reasons will be decided at this stage

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Dental surgery/extractions: Day1–2 to Day 8–9 [Figure 1]

It has been documented that, a short healing time between surgery to the start of RT, uncontrollable radiation-related side effects, persistent and untreated periapical pathology, periodontal disease, smoking, poor oral hygiene, trauma due to ill-fitting prosthesis, and surgical intervention in the irradiated region pose a significant risk for the occurrence of ORN.[50],[51],[52],[53],[54],[55],[56],[57] Despite there being no randomized clinical trials to prove extractions before RT prevents dental complications in cancer survivors,[58] studies reporting a significant increase in risk for predisposing the patient to ORN due to extractions performed before RT,[59],[60] no reported ORN due to extractions during RT,[60],[61] and only one in fifty patients developing ORN after RT,[62] it is still in principle agreed to eliminate all preventable predisposing factors well within a time frame before RT to decrease the risk of ORN.

Majority of HNC patients require multiple oral surgical procedures and require a mandatory gap of at least 2 weeks from the day of the last surgical procedure to the beginning of RT. It is, therefore, advisable to prioritize surgical appointments, carry out multiple extractions along with alveolectomy to remove sharp bony margins and place sutures for healing by primary intention. Surgical procedures must accompany by antibiotics and medications for pain relief and uneventful healing.

Depending upon the cumulative radiation dose (CRD), field of radiation (FOR), age, systemic health, consent of the patient, number and associated complexities of the surgical procedures, tumor site, and staging, mouth opening, and availability of the dentist are essential clinical considerations when deciding the day of starting extractions and subsequent scheduling of the appointments. When the above factors are favorable, it is valuable to preserve as many teeth as possible, and extractions are restricted to third molars.[63] On the day of the last surgical intervention, patients are referred to the radiation oncologist to obtain an appointment for RT after a minimum period of 2 weeks.

Prophylactic Extractions

Each tooth must be evaluated for its long-term prognosis based upon its strategic value, its potential to cause complications post-RT, CRD, and it's location with respect to the FOR [Table 1].[64] No case of ORN was reported in a systematic review when the total radiation dose was below 60 Gy.[55] It is advised to preserve as many healthy teeth as possible, provided a life-long meticulous oral care protocol be maintained in patients where CRD is less than 50 Gy.[65] Healthy teeth and root stumps entirely within the bone, not associated with any pathology but in the FOR, may be left in-situ without the risk of late problems [Figure 3]. The decision to attempt such traumatic extractions must be taken only after critically evaluating the prevailing factors like; time available before the definitive treatment, patients' systemic health, and consent. Teeth associated with pathology but within the confines of the bone should be attempted for removal on priority so that the time to definitive treatment is not delayed.
Table 1: Clinical parameters influencing the prophylactic extraction of teeth before RT. One or more factors in combination may warrant the extraction of clinically healthy teeth. A prudent clinician may plan in advance and safeguard the patient from anticipated diseases of dental origin in the event of tumor recurrence in the future

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Worn-out Teeth: Teeth with extensive wear due to long-standing bruxism and severe erosion should be considered for extraction before RT, due to the limitations of performing the extensive restorative treatment, paucity of time, patients' competing priorities, and economic concerns. Besides, the complex and precarious oral environment after RT may rule out restoring extensively worn teeth to standard functioning units and forbid their extractions as well.

Indicated Extractions[10],[11],[12],[13],[14],[15],[16],[17],[18],[19],[20],[21],[22],[23],[24],[25]

Teeth affected with non-restorable caries, issues with root canal treatment (RCT), and certain periodontal issues are considered as foci of infection and should be removed [Table 2].
Table 2: Teeth with following foci of infection are indicated for extractiond

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Periodontal Treatment

RT leads to the worsening of pre-existing periodontal disease due to its direct effects, increased plaque accumulation owing to hyposalivation and poor oral hygiene maintenance, and shift in oral microflora.[66],[67],[68],[69] Periodontal care beginning before RT and maintained throughout the patient's survivorship has shown improvement in the oral health of HNC patients.[70] Mechanical removal of the local etiological factors reverses the ongoing inflammatory processes in the oral cavity, brings the periodontium back to health, and aids in conditioning attachment apparatus to endure ionizing radiation.[71] The procedure may require one or two appointments within 3 days, depending upon the extent of periodontopathy. It is performed during the 2 weeks available from the day of the last surgical appointment and the beginning of RT [Figure 1].

Restorative treatment

Restorations of carious teeth are done when it ensures the longevity of the teeth and aid in supporting the prosthesis in the post-cancer period. The 14 days between the last oral surgical procedure and beginning of RT are duly utilized to restore maintainable supra-gingival sites, cervical lesions, recontouring/replacement of overhanging/over contoured restorations, and cementing provisional FPD's [Figure 1]. RCT is a safe and successful procedure with no reports of significant complications when performed after RT, therefore, it is prudent to defer intentional endodontic procedures until RT is completed and should be considered over-extraction in patients enduring RT dose >50 Gy.[72],[73] Apicoectomy and orthograde restorations may be attempted in young patients to preserve strategic teeth only when the time to definitive treatment is not getting unduly prolonged due to these dental procedures.

Fluoride application

In the systemic reviews by Hong et al., they have pointed out that the means of fluoride delivery system does not influence the RC, different fluoride products are similar, and one should use the fluoride product most acceptable to the patient.[17],[74]

Fluoride application should commence before the first scheduled RT session and continue till xerostomia persists, which in the majority of the patients is life-long.[17],[18],[38],[75],[76],[77],[78],[79] A home-based, daily topical application of 1% Sodium Fluoride (NaF) gel in customized trays is a reliable and effective means to prevent RC. NaF (0.05%) mouth rinse has also shown promise in preventing enamel demineralization when used twice daily.[80]

Patient compliance with the protocol, meticulous oral hygiene maintenance, and dietary alterations as advised are critical in decreasing the incidence of RC. It is anticipated that due to the economic constraints and poor compliance in the HNC patients, long-term success with the home care fluoride application in customized trays will be guarded.[39],[40],[75],[78],[80],[81],[82],[83] Considering these limitations, we advise and follow the professional application of neutral fluoride varnish before RT and then after every 3 months.[84]

Treatment Sequencing

The National Comprehensive Cancer Network recommends radiation to start within 6 weeks after resective surgery.[85],[86] Completing oral surgical procedures at the time of oncologic resection in HNC patients ensure the feasibility of maximum oral care being performed before RT [Figure 2].

With a tentative prosthetic plan in place and after taking informed consent from the patient, first and foremost, defective prostheses are removed to evaluate the abutments for their health and strategic value. Priority is then placed on the extractions, and other indicated surgical procedures. An aggressive approach is taken to perform all surgical interventions so that the treatment of the primary disease is not delayed. Restorative procedures are completed after oral prophylaxis during the 2-week window period between the last surgical procedure and the beginning of RT.

Clearance for Radiotherapy

The completion of periodontal and restorative procedures, fluoride application, and re-enforcement for a 3-month follow-up marks the clearance of a patient for RT.

 » Discussion Top

Efforts concentrated towards achieving oral status free of foci of infection before RT ensures uninterrupted definitive treatment by preventing any adverse oral events during RT and minimizing the unmet oral care needs in HNC survivors. The justification for prioritizing oral health over the treatment for the malignancy offers many merits which include but are not limited to; reduction in the cancer treatment-related symptoms of pain, decrease in the chances of acute dental infections while patients are undergoing cancer therapy, diminishes the impact of the oral microbial flora, prevents soft tissue infections that may have systemic sequelae, lessens the overall risk of dental complications, decreases in the incidence of ORN, improvement towards the feasibility and response to oral treatment after the completion of RT, and maintenance of as many healthy teeth as possible for improved function, esthetics, prosthetic rehabilitation, and OHRQOL.[10],[11],[12],[13],[14],[15],[16],[17],[18],[19],[20],[21],[22],[23],[24],[25],[87],[88]

The oncology centers utilizing the latest techniques and equipment have modified their oral treatment protocols related to dentoalveolar surgeries in the irradiated regions and have obtained acceptable outcomes especially concerning ORN. It is advisable to interpret the outcome with caution, as concrete evidence from randomized clinical trials is still not available to ascertain the risk of dental complications with such oral care protocols and concerns with regards to oral rehabilitation remain unaddressed.[89] In developing countries, multiple overlapping HNC patient-related and healthcare system-related factors like; lower socioeconomic status, higher illiteracy rates, ignorance towards the relationship between oral health and its effects of RT and vice-versa, limited motivation and access to oral care, the minimal scope of reimbursement of dental treatment costs, delayed referrals to oral health care settings before RT, lack of an adequate number of oral health facilities to cater to treatment needs of HNC patients, limitations of the tertiary care public hospitals (increased burden of care), insufficient time available for the appropriate treatment of oral issues before RT, lack of dedicated multidisciplinary dental team, and competing patient priorities where tumor prognosis is subjectively weighed as a priority over oral treatment, are major obstacles in putting known solutions to practice and to achieve oral health goals well within a time frame.[88],[90],[91],[92],[93],[94],[95],[96] Consequently, the treatment of many dental diseases in patients after treatment is limited to palliation [Figure 5].
Figure 5: Oral morbidities due to lack of interdisciplinary care before RT. (a) Severe ulceration of the grafted tissue due to continuous impingement from the maxillary teeth (b), corrective surgery for the treatment of ulcer resulted in difficulty in swallowing, drooling saliva, and feeding through a nasogastric tube (c), lone standing, periodontally compromised, supra-erupted maxillary and mandibular teeth, which should have been extracted at the time of surgery and/or before RT (d), extensive RC due to lack of oral care, high cumulative radiation dose, inevitable consequences of RT, and no follow-up care

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A need for early multidisciplinary consultation, referral to the oral health care settings, and a dedicated interdisciplinary dental team cannot be overemphasized.[20],[21] In addition to their involvement in timely preparation of patients for RT, oral health care providers play a crucial role in the diagnosis and mitigation of the incipient oral lesions, maintain a schedule for follow-up oral care, motivate patients, perform prosthetic rehabilitation as planned, and make swift referrals for suspected recurrences.[88]

To diminish the increased complexity of oral treatment needs in HNC survivors it is prudent to follow a protocol that respects time to the definitive treatment, addresses all oral foci of infection, and suits the native conditions of the patients. The guidelines available in the literature are empirical and may not be completely applicable to developing countries like ours, which constitute a large proportion of the HNC burden of the world. When adhering to the described protocol, most patients can be cleared from oral care settings for scheduled RT within 3 weeks from the day of patient presentation at the oral health care facility [Figure 1]. The patient and system-related limitations beyond the operator's control may increase the time to clearance for RT, therefore, incorporating additional 7 days to the protocol timeline promises redressal of the issues with regards to the outliers as well. Consequently, a 3–4-week oral care protocol seems appropriate to address the majority of the oral issues in most clinical situations, which is well within the 6-week time suggested by the National Comprehensive Cancer Network.[85]

The protocol we follow at our center is rational, achievable, and is aligned towards the sustained oral health care goals in HNC patients and can be utilized as a useful resource in multidisciplinary HNC care facilities.

 » Conclusion Top

The time-bound protocol described here provides sequential guidelines to address oral health issues relevant to HNC patients with an emphasis on the strict follow-up care throughout the survivorship of HNC patients. The success of the protocol, however, relies on the timely referrals to oral health care centers, availability of a dedicated interdisciplinary dental team, and complete coordination amongst the team members.

Declaration of patient consent

The authors certify that they have obtained all appropriate patient consent forms. In the form, the patient(s) has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.

Financial support and sponsorship

The described protocol was developed during a clinical trial funded by the Indian Council of Medical research.

Conflicts of interest

There are no conflicts of interest.

 » References Top

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