| CTRI Number |
CTRI/2025/03/083028 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A clinico-microbial study comparing the effectiveness of antimicrobial photodynamic therapy mediated by indocyanine green and methylene blue as an adjunct to non surgical periodontal therapy |
|
Scientific Title of Study
|
"COMPARATIVE EVALUATION OF EFFICACY OF INDOCYANINE GREEN AND METHYLENE BLUE MEDIATED ANTIMICROBIAL PHOTODYNAMIC THERAPY AS AN ADJUNCT TO NON-SURGICAL TREATMENT OF PERIODONTITIS. A CLINICO-MICROBIAL STUDY” |
| 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 K SUNEETHA |
| Designation |
PROFESSOR |
| Affiliation |
Drs. Sudha and Nageswara rao Siddartha institute of dental sciences |
| Address |
Drs Sudha and Nageswara rao siddartha institute of dental sciences,
Department of periodontics and implantology
room no. 3
chinnaoutapalli
gannavaram mandal
krishna district
Krishna ANDHRA PRADESH 521286 India |
| Phone |
9290574051 |
| Fax |
|
| Email |
ksuneetha@sids.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr K SUNEETHA |
| Designation |
PROFESSOR |
| Affiliation |
Drs. Sudha and Nageswara rao Siddartha institute of dental sciences |
| Address |
Drs Sudha and Nageswara rao siddartha institute of dental sciences,
Department of periodontics and implantology
room no. 3
chinnaoutapalli
gannavaram mandal
krishna district
Krishna ANDHRA PRADESH 521286 India |
| Phone |
9290574051 |
| Fax |
|
| Email |
ksuneetha@sids.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr K SUNEETHA |
| Designation |
PROFESSOR |
| Affiliation |
Drs. Sudha and Nageswara rao Siddartha institute of dental sciences |
| Address |
Drs Sudha and Nageswara rao siddartha institute of dental sciences,
Department of periodontics and implantology
room no. 3
chinnaoutapalli
gannavaram mandal
krishna district
Krishna ANDHRA PRADESH 521286 India |
| Phone |
9290574051 |
| Fax |
|
| Email |
ksuneetha@sids.edu.in |
|
|
Source of Monetary or Material Support
|
| This study will be carried out in department of periodontics and implantology of Dr. Sudha and Nageswara rao Siddartha Institute of dental sciences
Chinnaoutapalli
Gannavaram mandal
Krishna district
PINCODE: 521286
Andhra Pradesh
India
|
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [] |
|
|
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 Mounasri P |
Drs. sudha and nageswararao siddartha institute of dental scinences |
Department of periodontics and implantology
room no. 3 Krishna ANDHRA PRADESH |
7386862468
mounasriprathipati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee Drs Sudha and Nageswara rao siddartha institute of dental sciences |
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 |
Indocyanine green |
Photosensitizing agent |
| Comparator Agent |
Methylene Blue |
Photosensitizing agent |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients with minimum 20 teeth.
Patients with Stage II Grade A periodontitis having at least 3 teeth with probing depth of 5 mm.
|
|
| ExclusionCriteria |
| Details |
Consumption of tobacco in any form.
Pregnant and lactating women.
Patients taking medications that may interfere with periodontal therapy.
Previous history of allergic reaction to the use of any kind of dye.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Plaque index
Gingival index
Probing pocket depth
Clinical attachment level |
At baseline, 1 and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Microbial analysis of total viable anaerobic count (TVAC) |
At baseline, 1 and 3 months |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
| Photodynamic therapy (PDT) is an oxygen dependent photochemical reaction that occur upon light mediated activation of a photosensitizing compound leading to generation of cytotoxic reactive oxygen species.PDT has emerged in recent years as a non-invasive therapeutic option.Many photosensitizers like methylene blue, toluidine blue has proven to be effective. But certain disadvantages linked to these agents, such as, incidental staining, need to purchase of separate laser units etc., establish the need for a potential new photosensitizer transcending these disadvantages.A Food and Drug Administration (FDA) dye, Indocyanine green (ICG) was used in hepatic function diagnostics, fluorescent angiography in ophthalmology and later in cardiology had become established as new in dentistry.A new photosensitizer called indocyanine green (ICG) has been developed which gets activated upon absorbing light of specific wavelength. The fact that ICG does not require oxygen can make it even more effective in anaerobic subgingival area as compared to other photosensitizers and used for the treatment of periodontitis.The disadvantages of earlier dyes, better efficiency and safety with ICG and successful in vitro studies using this dye against periopathogenic bacteria, led to present studies. Not many studies have been conducted using ICG dye to study effect of aPDT in periodontitis.Not many studies have been conducted to compare the clinical and microbial efficacy between ICG and methylene blue. The present study helps to evaluate the clinical and microbiological effects of ICG mediated aPDT as an adjunct to non-surgical management of chronic periodontitis. | And to evaluate and compare the clinical and microbiological effects between ICG(1mg/ml) and Methylene blue (1%) using low power diode laser (0.8W, 940nm) in the management of chronic periodontitis. |