| CTRI Number |
CTRI/2025/01/079321 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to study the ability of Photodynamic therapy in the improvement of gum problems and antibacterial action by comparing it with Scaling and Root planing in patients with Stage III Grade A periodontitis |
|
Scientific Title of Study
|
Evaluation of efficacy of Photodynamic therapy as an adjunct to Scaling and Root Planing in patients with Stage III Grade A periodontitis - a randomized controlled split mouth study with clinico-microbiological assessment |
| 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 Rajeswari R |
| Designation |
Post Graduate |
| Affiliation |
Government Dental College and Hospital, Cuddalore district |
| Address |
Department of Periodontics
Government Dental College and Hospital erstwhile Rajah Muthaiah Dental College and Hospital, Cuddalore district, Chidambaram 608002
Cuddalore
TAMIL NADU
608002
India |
| Phone |
8682899371 |
| Fax |
|
| Email |
rajiravishankar20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Krishnan |
| Designation |
Professor and Head |
| Affiliation |
Government Dental College and Hospital, Cuddalore district |
| Address |
Department of Periodontics
Government Dental College and Hospital erstwhile Rajah Muthaiah Dental College and Hospital, Cuddalore district, Chidambaram 608002
Cuddalore
TAMIL NADU
608002
India |
| Phone |
9443496615 |
| Fax |
|
| Email |
drkrish66@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Krishnan |
| Designation |
Professor and Head |
| Affiliation |
Government Dental College and Hospital, Cuddalore district |
| Address |
Department of Periodontics
Government Dental College and Hospital erstwhile Rajah Muthaiah Dental College and Hospital, Cuddalore district, Chidambaram 608002
TAMIL NADU
608002
India |
| Phone |
9443496615 |
| Fax |
|
| Email |
drkrish66@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Hospital erstwhile Rajah Muthiah Dental College and Hospital Cuddalore district For infrastructure |
|
|
Primary Sponsor
|
| Name |
Dr Rajeswari R |
| Address |
Department of Periodontics
Government Dental College and Hospital erstwhile Rajah Muthiah Dental College and Hospital Cuddalore district Chidambaram 608002 |
| Type of Sponsor |
Other [Self funding] |
|
|
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 Rajeswari R |
Government Dental College an Hospital, Cuddalore district |
Department of Periodontics
Government Dental College and Hospital erstwhile Rajah Muthiah Dental College and Hospital Cuddalore district Chidambaram 608002
Cuddalore
TAMIL NADU |
8682899371
rajiravishankar20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Medical College and Hospital, Cuddalore district, Annamalai Nagar 608002, INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K056||Periodontal disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Photodynamic therapy |
0.01% methylene blue activated by diode laser of 650 nm wavelength 2W power for 60 seconds inside the periodontal pocket |
| Comparator Agent |
Scaling and Root Planing |
Removal of supragingival and subgingival plaque and calculus using Ultrasonic scaler and area specific gracey curette |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Stage III grade A periodontitis:
-CAL more than 5 mm
-Bleeding on probing(BOP) in at least 30% of the teeth/sites
-Pocket depth of more than 6 mm
-Bone loss extends to the middle or apical third of affected roots
-Tooth loss due to periodontitis involving no more than 4 teeth.
2. Patients ready to comply with oral hygiene measures.
3. Patients free from any systemic disease or taking drugs that affect healing. |
|
| ExclusionCriteria |
| Details |
1. Patients with any known systemic diseases.
2. History of any recent infections within 6 months of study.
3. Smokers
4. Patients on any antibiotics for 3 months.
5. Pregnancy / lactation.
6. Patients with prior history of periodontal therapy within 6 months of the study.
7. Necrotizing Ulcerative Gingivitis/ Necrotizing Ulcerative Periodontitis. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Probing pocket depth changes |
At baseline and after 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gingival index |
1 month |
| Plaque index |
1 month |
| Clinical attachment level |
1 month |
| Microbial load |
1 month |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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 4 |
|
Date of First Enrollment (India)
|
28/02/2025 |
| 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="1"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Informed Consent Form
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [rajiravishankar20@gmail.com].
- For how long will this data be available start date provided 28-02-2025 and end date provided 22-02-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a randomized controlled split-mouth, multicentre trial comparing the efficacy of photodynamic therapy as an adjunct to Scaling and Root Planing in patients with Stage III Grade A periodontitis that will be conducted in India at Government Dental College and Hospital, Cuddalore district, Chidambaram 608002. The primary outcome measures will be Probing Pocket depth evaluation at baseline and 1 month after intervention. The secondary outcomes will be the Gingival index, Plaque index, Clinical attachment level, and microbial load at baseline and 1 month after intervention. |