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CTRI Number  CTRI/2023/12/060659 [Registered on: 21/12/2023] Trial Registered Prospectively
Last Modified On: 20/12/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To check the difference of laser and 2% citric acid solution in prevention of radiotherapy induced xerostomia patient. 
Scientific Title of Study   Comparative effectiveness of Low- Level Laser Therapy(810nm) and 2% citric acid solution in Prevention of radiotherapy-induced Xerostomia. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sakshi Batra 
Designation  RESIDENT 
Affiliation  Banaras Hindu University 
Address  Department of Oral Medicine And Radiology, Faculty of Dental Sciences, Institute of medical sciences, Banaras Hindu University

Varanasi
UTTAR PRADESH
221005
India 
Phone  7275567124  
Fax    
Email  drsakshioralmed@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR ADIT 
Designation  PROFESSOR 
Affiliation  BANARAS HINDU UNIVERSITY 
Address  Department of Oral Medicine And Radiology, Faculty of Dental Sciences, Institute of medical sciences, Banaras Hindu University

Varanasi
UTTAR PRADESH
221005
India 
Phone  9451525522  
Fax    
Email  adit@bhu.ac.in  
 
Details of Contact Person
Public Query  
Name  DR ADIT 
Designation  PROFESSOR 
Affiliation  BANARAS HINDU UNIVERSITY 
Address  Department of Oral Medicine And Radiology, Faculty of Dental Sciences, Institute of medical sciences, Banaras Hindu University

Varanasi
UTTAR PRADESH
221005
India 
Phone  9451525522  
Fax    
Email  adit@bhu.ac.in  
 
Source of Monetary or Material Support  
SELF(Dr. SAKSHI BATRA UNIT OF ORAL MEDICINE AND RADIOLOGY, FACULTY OF DENTAL SCIENCES,INSTITUTE OF MEDICAL SCIENCES,BANARAS HINDU UNIVERSITY,VARANASI,221005 
 
Primary Sponsor  
Name  SAKSHI BATRA  
Address  Faculty of Dental Sciences, Department of Oral Medicine And Radiology, Institute of Medical Sciences, Banras Hindu University,221005 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrSAKSHI BATRA  SIR SUNDERLAL HOSPITAL,BANARAS HINDU UNIVERSITY  ROOM NO.1,Unit of oral medicine and radiology. depatment:faculty of dental sciences, instituute of medical sciences, banaras hindu university
Varanasi
UTTAR PRADESH 		 7275567124

drsakshioralmed@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONALETHICALCOMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  2% CITRIC ACID  15mL of a 2% citric acid solution applied as a mouth rinse for 30 sec.Depending on radiotherapy session approx 3 months 
Intervention  LOW LEVEL LASER THERAPY  wavelength of 810 nm, 100-mW output power, laser beam area of approximately 1cm2, three times a week, on alternate days. Therapy will be initiated before the first radiotherapy session and ended after the last session, depending on radiotherapy session approx 3 months. The total energy per session (84J) will be divided into 14 irradiation points. Each irradiation point received a dose of 6 J over an irradiation time of 60 s. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  i. Histologically proven squamous cell carcinoma of head and neck.
ii. Patients treated with upfront r̥adio- therapy or chemo-radiotherapy with curative intent.
iii. Patients of both gender and between 18 years to 70 years of age.
iv. Level I and II neck nodes to be part of the radiotherapy portal.
 
 
ExclusionCriteria 
Details  i. Systemic condition with hyposalivation e.g. DM, End stage renal disease etc.
ii. Autoimmune diseases such as Sjogren Syndrome by established diagnosis criteria.
iii. Infectious diseases
iv. Collagen diseases, as were those with incipient tumors (stage T1 or T2) limited to the larynx, as well as those with trismus (reduced mouth opening capacity) due to surgical sequelae.
v. Already on xerostomic drugs (antiretroviral medications, antihistamines, anticholinergics, antihypertensives, decongestants, narcotic analgesics, tricyclic antidepressants)
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Stimulated and unstimulated whole saliva flow rate   baeline
3 week
end of RT
3 month of completion of RT 
 
Secondary Outcome  
Outcome  TimePoints 
11-item modified Xerostomia Inventory-Dutch questionnaire version   before therapy and end of the therapy 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/01/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This study aims to compare the efficacy of low-level laser therapy and a 2% citric acid solution as mouth rinses in preventing radiotherapy-induced xerostomia in cancer patients. The research will involve a randomized control trial with a concurrent parallel design, utilizing a sample size of 20 in each group through simple randomized sampling. The low-level laser, with specific parameters, will be applied three times a week before and after radiotherapy sessions. The control group will receive a 2% citric acid solution as a mouth rinse. Salivary flow rates will be assessed through unstimulated and stimulated sialometry tests at various time points during and after radiotherapy, using established norms. Additionally, the 11-item modified Xerostomia Inventory-Dutch questionnaire will be employed to measure the severity of dry mouth symptoms. The study aims to evaluate and compare the effectiveness of both interventions in reducing radiation-induced xerostomia, providing valuable insights into potential preventive measures for this common side effect in head and neck cancer patients undergoing radiotherapy. 
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