| 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
|
|
|
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
|
|
|
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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