| CTRI Number |
CTRI/2026/04/107995 [Registered on: 09/04/2026] Trial Registered Prospectively |
| Last Modified On: |
08/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate the effectiveness of deep dental cleaning alone and in combination with platelet therapy and light-based therapy in patients with gum disease |
|
Scientific Title of Study
|
Clinical evaluation of scaling and root planing alone and as an adjunct to injectable platelet-rich fibrin, photobiomodulation and their combined effect in chronic periodontitis - A randomized clinical 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 Vedantee Pandya |
| Designation |
1 st year post graduate student |
| Affiliation |
College of dental science amargagh bhavnagar |
| Address |
Girls hostel College of dental science amargadh bhavnagar room no. 5 department of periodontology ,College of dental science amargadh bhavnagar Bhavnagar GUJARAT 364210 India |
| Phone |
6356815068 |
| Fax |
|
| Email |
pandyavedantee@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Jeeth Rai |
| Designation |
Professor of department of periodontology |
| Affiliation |
College of dental science amargadh bhavnagar |
| Address |
room no.5 department of periodontology college of dental science amargadh room no.5 department of periodontology college of dental science amargadh Bhavnagar GUJARAT 364210 India |
| Phone |
9011291375 |
| Fax |
|
| Email |
jeeth_rai@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Jeeth Rai |
| Designation |
Professor of department of periodontology |
| Affiliation |
College of dental science amargadh bhavnagar |
| Address |
room no.5 department of periodontology college of dental science amargadh room no.5 department of periodontology college of dental science amargadh Bhavnagar GUJARAT 364210 India |
| Phone |
9011291375 |
| Fax |
|
| Email |
jeeth_rai@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Vedantee Pandya |
| Address |
room no.5 department of periodontology college of dental science amargadh 364210 bhavnagar gujrat 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 Vedantee Pandya |
College of Dental Science and Hospital, Amargadh |
room no.5 department of periodontology college of dental science amargadh Bhavnagar GUJARAT |
6356815068 - pandyavedantee@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, College of Dental Science and Hospital, Amargadh |
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 |
| Comparator Agent |
SCALING AND ROOT PLANING |
SUPRA GINGIVAL SCALING
SUBGINGIVAL SCALING
ROOT PLANING |
| Intervention |
SRP WITH IPRF
|
SRP followed by IPRF once
|
| Intervention |
SRP With IPRF and PBM |
SRP With IPRF once and PBM baseline 3 days and 7 days |
| Intervention |
SRP With PBM |
SRP With PBM Baseline 3 days and 7 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1)Aged between 30 and 75 with chronic periodontitis
2) Subjects having at least 2 teeth in each quadrant with PPD 4-6 mm.
|
|
| ExclusionCriteria |
| Details |
1) Systemically compromised Patients
2) Pregnant and lactating females
3) Smokers , tobacco chewers
4)Mobile teeth
5)Furcation involvement
6) Patients taking any type of medication that effect mucosal healing
7)Patient who were on any antibiotic therapy since last 6 months
8) Patients who have been treated previously for periodontitis |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Objectives
1.To evaluate and compare the changes in periodontal pocket depth (PPD) and clinical attachment level(CAL).
|
6 weeks and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate & compare changes in plaque index(PI) & reduction in sulcus bleeding index(SBI) & gingival index(GI). |
6 weeks & 3 months |
|
|
Target Sample Size
|
Total Sample Size="44" Sample Size from India="44"
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 2 |
|
Date of First Enrollment (India)
|
17/08/2026 |
| 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)
|
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 randomized clinical trial will be conducted on 44 sample size with chronic periodontitis, who will be randomly allocated into four groups of 11 patients each to evaluate the clinical effectiveness of scaling and root planing (SRP) alone and in combination with injectable platelet-rich fibrin photobiomodulation therapy and their combined use. Clinical parameters will be recorded at baseline and follow-up and the outcomes will be statistically analyzed to compare the efficacy of the four treatment modalities. |