| CTRI Number |
CTRI/2022/09/045334 [Registered on: 08/09/2022] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Preventive
Screening
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TO compare and evaluate the effects of Photodynamic therapy with conventional scaling and root planing at different intervals in chronic periodontitis patient: A Clinico-microbiological study |
|
Scientific Title of Study
|
Comparative evaluation of Photodynamic therapy with conventional scaling and root planing at different frequencies in chronic periodontitis patient: A Clinico-microbiological study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr APOORVA G |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
KVG DENTAL COLLEGE AND HOSPITAL |
| Address |
Post graduate student
Department of Periodontology
Room no 11
KVG DENTAL COLLEGE AND HOSPITAL, KURUNJIBAGH, SULLIA, DAKSHINA KANNADA, KARNATAKA 574327
KVG DENTAL COLLEGE AND HOSPITAL, KURUNJIBAGH, SULLIA, DAKSHINA KANNADA, KARNATAKA 574327
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
8792246513 |
| Fax |
|
| Email |
dr.apoorva135@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M M DAYAKAR |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
KVG DENTAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF PERIODONTOLOGY
KVG DENTAL COLLEGE AND HOSPITAL, KURUNJIBAGH, SULLIA, DAKSHINA KANNADA, KARNATAKA 574327
KVG DENTAL COLLEGE AND HOSPITAL, KURUNJIBAGH, SULLIA, DAKSHINA KANNADA, KARNATAKA 574327
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9448167427 |
| Fax |
|
| Email |
mmdayakar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr APOORVA G |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
KVG DENTAL COLLEGE AND HOSPITAL |
| Address |
Department of periodontology
Room no 11
KVG DENTAL COLLEGE AND HOSPITAL, KURUNJIBAGH, SULLIA, DAKSHINA KANNADA, KARNATAKA 574327
KVG DENTAL COLLEGE AND HOSPITAL, KURUNJIBAGH, SULLIA, DAKSHINA KANNADA, KARNATAKA 574327
Dakshina Kannada
KARNATAKA
560079
India |
| Phone |
8792246513 |
| Fax |
|
| Email |
dr.apoorva135@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontology
Room no 11
KVG DENTAL COLLEGE AND HOSPITAL
KURUNJIBAGH, SULLIA, DAKSHINA KANNADA, KARNATAKA 574327 |
|
|
Primary Sponsor
|
| Name |
KVG DENTAL COLLEGE AND HOSPITAL |
| Address |
KVG DENTAL COLLEGE AND HOSPITAL, KURUNJIBAGH, SULLIA, DAKSHINA KANNADA, KARNATAKA 574327 |
| Type of Sponsor |
Other [Private dental college] |
|
|
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 Apoorva G |
KVG dental college and hospital |
Department of periodontology
Post graduate section
Room no 11
KURUNJIBAGH, SULLIA, DAKSHINA KANNADA, KARNATAKA 574327
Dakshina Kannada
KARNATAKA |
8792246513
dr.apoorva135@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS 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 |
photodynamic therapy using low level laser with wavelength of 660nm,
0.1mg/ml of toluidine blue O dye |
One time exposure to photodynamic therapy using low level laser with wavelength of 660nm and 0.1mg/ml of toluidine blue O dye |
| Comparator Agent |
Photodynamic therapy using low level laser with wavelength of 660nm, 0.1 ml/ml of toluidine blue O dye |
Two time exposure to Photodynamic therapy using low level laser with wavelength of 660nm, 0.1 ml/ml of toluidine blue O dye |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy patient.
chronic periodontitis patient with >5mm of periodontal probing depth present in each quadrant. |
|
| ExclusionCriteria |
| Details |
Patients with known systemic diseases.
Allergic to toluidine blue.
Patient who underwent treatment with antibiotics within the last six months.
Patient who underwent treatment with anti-inflammatory drug within the last three months.
Patient undergoing orthodontic treatment.
Patient who underwent periodontal therapy within the last six months.
Pregnancy or use of oral contraceptive.
Smoking.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the reduction of periodontal probing depth |
baseline
6 week
12 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess the microbial count in the samples collected after treatment |
baseline
6 week
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
13/09/2022 |
| Date of Study Completion (India) |
31/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/03/2023 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a randomized, double blinded, single center trial comparing and evaluating the clinical and microbial effects of photodynamic therapy using low level laser of 660nm wavelength and 0.1 mg/ml of Toluidine blue O dye irrigated for 60 seconds. Low level laser exposure done for 1 minute using swiping motion from apical to coronal direction within the periodontal pocket on the assigned treatment side. Each quadrant will be receiving scaling and root planing. one of the quadrant will receive one time exposure of Photodynamic therapy, other quadrant will be receiving two time exposure of Photodynamic therapy, In the remaining two quadrant one side will be receiving scaling and root planning treatment along with irrigation of 0.1 mg/ml of toluidine blue O dye while the other will be receiving scaling and root planing. Primary outcome is by assessing the clinical parameters such as gingival index, bleeding index, plaque index, periodontal probing depth and clinical attachment level which will be recorded during each appointments. Secondary outcome is by assessing the microbiological analysis by counting the colony forming units based on the samples drawn after each appointments. |