| CTRI Number |
CTRI/2021/04/032704 [Registered on: 09/04/2021] Trial Registered Prospectively |
| Last Modified On: |
02/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of photodynamic therapy in the management of gum disease |
|
Scientific Title of Study
|
Comparing the efficacy of photodynamic therapy with 1% malachite green or 1% methylene blue when used adjunctively to scaling and root planing in the treatment of chronic periodontitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Alina Pauly |
| Designation |
Postgraduate |
| Affiliation |
Rajarajeswari Dental College and Hospital |
| Address |
Rajarajeswari Dental College and Hospital, Ramohalli cross, Kumbalgodu, Mysore road, Bangalore
Bangalore
KARNATAKA
560074
India |
| Phone |
8197808384 |
| Fax |
|
| Email |
alinapauly94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vinaya Kumar R |
| Designation |
Professor |
| Affiliation |
Rajarajeswari Dental College and Hospital |
| Address |
Rajarajeswari Dental College and Hospital, Ramohalli cross, Kumbalgodu, Mysore road, Bangalore
Bangalore
KARNATAKA
560074
India |
| Phone |
9844301016 |
| Fax |
|
| Email |
drrvinayakumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vinaya Kumar R |
| Designation |
Professor |
| Affiliation |
Rajarajeswari Dental College and Hospital |
| Address |
Rajarajeswari Dental College and Hospital, Ramohalli cross, Kumbalgodu, Mysore road, Bangalore
Bangalore
KARNATAKA
560074
India |
| Phone |
9844301016 |
| Fax |
|
| Email |
drrvinayakumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeswari Dental College and Hospital |
|
|
Primary Sponsor
|
| Name |
Alina Pauly |
| Address |
Rajarajeswari Dental College and Hospital, Ramohalli cross, Kumbalgodu, Mysore road, Bangalore- 560074 |
| 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 |
| Alina Pauly |
Rajarajeswari Dental College and Hospital |
room no 4, Rajarajeswari Dental College and Hospital, Ramohalli cross, Kumabalgodu, Mysore road, Bangalore- 560074.
Bangalore
KARNATAKA |
8197808384
alinapauly94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical committee of Rajarajeswari Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1% malachite green
|
1% malachite green at baseline. |
| Comparator Agent |
1% methylene blue |
1% methylene blue at baseline. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
A minimum of one tooth each in two contralateral quadrants having at least one site with a probing depth of ≥ 5mm and ≤ 7mm. Systemically healthy patients.
Not received any antibiotics in the past 6 months.
Plaque and Gingival index score of less than 1 |
|
| ExclusionCriteria |
| Details |
Smokers.
Pregnant and lactating women.
Allergic to malachite green or methylene blue.
Active periodontal treatment within the last 6 months. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in probing depth(PD) and clinical attachment level(CAL) will be observed in the experimental sites. |
baseline, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in plaque index scores, gingival index scores and bleeding index scores will be documented |
At the baseline visit, 3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "5"
Final Enrollment numbers achieved (India)="5" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/04/2021 |
| Date of Study Completion (India) |
24/11/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
Photodynamic therapy (PDT) is an approach that combines low level laser light with a photosensitizer that binds to the target cells. In the excited state, photosensitizers react with oxygen in the environment generating reactive oxygen species that cause oxidative damage to target cells. Thus, PDT can be an alternative for reducing bacterial load in pockets.Studies have shown a significant reduction in probing depth (PD) when PDT was employed as an adjunct to SRP. However, there is dearth of studies in literature that have compared the photosensitizers, methylene blue and malachite green when used as dyes in PDT. Hence, this study is being undertaken to compare the efficacy of 1% methylene blue and 1% malachite green in improving clinical parameters when used as a component of PDT in chronic periodontitis patients.
|