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CTRI Number  CTRI/2024/05/068104 [Registered on: 30/05/2024] Trial Registered Prospectively
Last Modified On: 03/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Probiotic 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the effect of collagen supplement on chronic periodontitis patient and on nitrtic oxide level in the saliva. 
Scientific Title of Study   A clinico biochemical study to evaluate the efficacy of collagen peptide supplements with an intervention of nonsurgical periodontal therapy and on salivary nitric oxide level in chronic periodontitis. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Yogita Kshirsagar 
Designation  Post Graduate Student  
Affiliation  Yogita Dental College and Hospital 
Address  Department of Periodontology room no 24 Yogita dental college and hospital Naringi Riverside At Post Tal Dist SH104 Khed Maharashtra

Ratnagiri
MAHARASHTRA
415709
India 
Phone  8928930921  
Fax    
Email  yoksh.yk.yk@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prashanth Shetty  
Designation  Professor  
Affiliation  Yogita dental college and hospital 
Address  yogita dental college and hospital Naringi Riverside At Post Tal Dist SH104 Khed ratnagiri Maharashtra

Ratnagiri
MAHARASHTRA
415709
India 
Phone  9886191999  
Fax    
Email  drprashanthshetty3@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prashanth Shetty  
Designation  Professor  
Affiliation  Yogita dental college and hospital 
Address  yogita dental college and hospital Naringi Riverside At Post Tal Dist SH104 Khed ratnagiri Maharashtra

Ratnagiri
MAHARASHTRA
415709
India 
Phone  9886191999  
Fax    
Email  drprashanthshetty3@gmail.com  
 
Source of Monetary or Material Support  
yogita dental college and hospital khed ratnagiri 415709 India 
 
Primary Sponsor  
Name  Yogita Kshirsagar 
Address  Department of Periodontology room no 24 Yogita dental college and hospital khed ratnagiri 415709 India 
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 Yogita Kshirsagar  Yogita dental college and hospital  Department of Periodontology room no 24 Yogita Dental College Hospital, Khed
Ratnagiri
MAHARASHTRA 
8928930921

yoksh.yk.yk@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Collagen peptide supplement  Systemically daily once 5 gram for 2 months  
Comparator Agent  without collagen supplement  without collagen supplement  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Minimum 20 natural teeth
Diagnosis: Chronic mild to moderate periodontitis
Probing depth: 3-7mm
Clinical Attachment Loss: 2-4mm
Bleeding on probing
Systemically healthy patients
Patient agreed to give the consent only are included
 
 
ExclusionCriteria 
Details  Tobacco-smokers, electronic cigarette users, smokeless tobacco product users, alcohol users.
Individuals that had used antibiotics and/or steroids within the past 3-month.
Individuals with any systemic diseases.
Lactating and/or pregnant females.
Completely edentulous individuals
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Decrease in periodontal probing depth and clinical attachment loss
 
Baseline
Four weeks
Eight weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
Decrease in the level of salivary nitric oxide
 
Baseline
Four weeks
Eight weeks
 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
Final Enrollment numbers achieved (Total)= "55"
Final Enrollment numbers achieved (India)="55" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/07/2024 
Date of Study Completion (India) 21/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  

The primary objective of my clinical trial is "Can collagen peptide supplement enhance the effect of non-surgical periodontal therapy and decrease the level of salivary nitric oxide in chronic periodontitis patients?" 

METHODOLOGY Study design:

The present study is a double blind, parallel group, clinico-biochemical, randomised controlled trial with a 2-months period.

 Group A: 23 Chronic periodontitis patients with collagen peptide supplement as an adjunct to scaling and root planing and salivary nitric oxide level.

 Group B: 23 Chronic periodontitis patients with scaling and root planing alone and salivary nitric oxide level.

Study setting:

Subjects with chronic mild to moderate periodontitis will be selected for the study from the out-patient department, Department of Periodontology.

Sample size:

A sample size of minimum 46 patients (Group A= 23 and Group B= 23) is selected for the study.

Clinical procedure: 1st visit: baseline

 1.     Informed consent from the subject will be obtained. 

2.     At 1st visit, detailed medical, dental histories as well as periodontal examination will be recorded and patients fulfilling the inclusion criteria will be included in the study.

3.     Unstimulated saliva samples will be taken to evaluate the salivary nitric oxide level.

4.     Thorough scaling and root planing will be done for all patients.

5.     Test group patients will be given hydrolyzed collagen peptide powder sachets of 5g/day for two months that should be taken in water half an hour before meal (lunch).

Nitric oxide level in saliva:

Salivary estimation of NO will be carried out using the Griess colorimetric reaction in the laboratory. 

2nd visit: 4 weeks

Follow up and evaluation of clinical parameters.

 3rd visit: 8 weeks

Follow up and evaluation of clinical parameters.

Unstimulated saliva sample collection to re-evaluate salivary nitric oxide level.


 
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