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CTRI Number  CTRI/2024/11/077083 [Registered on: 20/11/2024] Trial Registered Prospectively
Last Modified On: 19/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To evaluate increase in the salivary flow rate of xerostomic patients post-radiotherapy by using salivary stimulants 
Scientific Title of Study   Efficacy of biotene oral balance system and xerostom salivary system on salivary properties, salivary biomarkers (beta- defensin, mucin-7) and caries susceptibility in patients with irradiation induced xerostomia: a single blinded randomized controlled trial 
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 Anam Alam 
Designation  MDS Student of Conservative Dentistry and Endodontics 
Affiliation  ITS-CDSR, Muradnagar 
Address  Room no 6, PG Clinic, Department of Conservative Dentistry and Endodontics, Delhi-Meerut Road, Muradnagar, Ghaziabad

Ghaziabad
UTTAR PRADESH
201206
India 
Phone  8766273472  
Fax    
Email  anamalam97@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sonali Taneja  
Designation  Professor, HOD, Dean-PG STUDIES 
Affiliation  ITS-CDSR, Muradnagar 
Address  Department of Conservative Dentistry and Endodontics, ITS Centre for Dental Studies and Research, Delhi-Meerut Road, Muradnagar, Ghaziabad

Ghaziabad
UTTAR PRADESH
201206
India 
Phone  9891688100  
Fax    
Email  sonalitaneja@its.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Sonali Taneja  
Designation  Professor, HOD, Dean-PG STUDIES 
Affiliation  ITS-CDSR, Muradnagar 
Address  Department of Conservative Dentistry and Endodontics, ITS Centre for Dental Studies and Research, Delhi-Meerut Road, Muradnagar, Ghaziabad

Ghaziabad
UTTAR PRADESH
201206
India 
Phone  9891688100  
Fax    
Email  sonalitaneja@its.edu.in  
 
Source of Monetary or Material Support  
ITS Center for Dental Studies & Research, NH-34, Muradnagar, Asalat Nagar, Ghaziabad, Near KIET College, Uttar Pradesh 201206 
 
Primary Sponsor  
Name  DrAnam Alam 
Address  Room No. A-103, PG Girls Hostel, ITS Dental College, Muradnagar, Ghaziabad 
Type of Sponsor  Other [Self] 
 
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 
Dr Anam Alam  ITS Center for Dental Studies & Research, Muradnagar  Room no 6, PG Clinic, Department of Conservative Dentistry and Endodontics, Delhi-Meerut Road, Muradnagar, Ghaziabad
Ghaziabad
UTTAR PRADESH 		 8766273472

anamalam97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
I.T.S Institutional Ethics Committee (IIEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified, (2) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Biotene oral balance gel and toothpaste   It has lactoperoxidase, lysozyme, glucose oxidase and xylitol which are responsible for its anti bacterial activity and also makes it a salivary stimulant. Given for 6 months. 
Comparator Agent  Xerostom gel and toothpaste  It mainly constitutes Olive oil, Betaine & Xylitol. Olive oil acts as a lubricant, anti caries & anti inflammatory agent. Betaine is an osmoprotectant. Xylitol acts as a salivary stimulant. Given for 6 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.With previous radiotherapy treatment where the field of irradiation encompasses the major and minor salivary glands.
2.With a subjective complaint of dry mouth.
3.With at least 10 remaining natural teeth and taking nutrition orally.
4.Participants should have finished radiotherapy 1 week prior to the study with a radiation dose more than 60Gy, present with skin integrity, have no history of neck dissection level I or any tumor lesion in the salivary glands.
5.Participants should report complaints compatible with xerostomia and hyposalivation, which will be later confirmed by sialometry.
 
 
ExclusionCriteria 
Details  1.Patients with performing stimulated salivary flow rate (SSF) above 1mL/min.
2.Patients having severe dysphagia, or under hyposalivation treatment or salivary stimulants.
3.Patients whose radiation field did not include jaws, edentulous patients.
4.Those receiving a total radiotherapy dose of 50Gy or less.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Increase in the salivary flow, pH & buffering capacity & decrease in the caries susceptibility  Baseline
1 month
3 months
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
none  none 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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 3 
Date of First Enrollment (India)   30/11/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [anamalam97@gmail.com].

  6. For how long will this data be available start date provided 15-08-2023 and end date provided 17-03-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Head and neck carcinoma (HNC) is the sixth most common cancer worldwide, accounting for 2.8% of all malignancies. Approximately 6,30,000 patients are diagnosed each year with an annual death rate of 3,50,000. Radiotherapy (RT) plays a pivotal role in the curative treatment in the majority of patients of head and neck cancer either as a single modality or in conjunction with surgery. Despite the beneficial aspects of radiotherapy in locoregional tumor control, the damage inflicted to normal tissues surrounding the tumor such as salivary glands remains a significant problem. Salivary glands are remarkably sensitive to radiation, a phenomenon attributed to disruption of the plasma membrane on secretory salivary acinar cells and apoptosis.Radiotherapy induced salivary gland dysfunction results in hyposalivation (reduction in salivary flow rate), xerostomia (i.e., the sensation of oral dryness), mucositis, oral infections, difficulty with mastication, dysphagia and loss of taste. As a consequence of the adverse effects directly related to salivary gland hypofunction, the quality of life following radiation therapy for the head and neck cancer patients may severely deteriorate, characterized by restriction of daily activities, a poorer general health, social disabilities and malnutrition. Effective management of dry mouth symptoms may improve nutritional status of patients and reduce the disease burden on these patients as well thereby enhancing their overall well being.  A new concept & generation of dry mouth care system have been marketed as salivary stimulants. These product formulations not only mimic the essential salivary peroxidase system, but also introduce other naturally occurring salivary components to help supplement the mouth’s natural antibacterial and immune mechanism.These are marketed as system comprising salivary stimulating gels, antibacterial toothpaste and alcohol free fluoride mouthwash.  
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