| CTRI Number |
CTRI/2022/08/045099 [Registered on: 30/08/2022] Trial Registered Prospectively |
| Last Modified On: |
27/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to evaluate the effect of laser assisted therapy using indocyanine green dye on bacterial infection levels in patients with gum disease. |
|
Scientific Title of Study
|
Effectiveness of photodynamic therapy using indocyanine green on microbial and procalcitonin levels in periodontitis patients - A comparative split mouth randomized controlled clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arya Anil |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
Rajiv Gandhi University of Health Sciences |
| Address |
Room no.5, Department of Periodontology, Bangalore institute of dental sciences and hospital, bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
08921523418 |
| Fax |
|
| Email |
aryaanil018@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Sri Rangarajan |
| Designation |
HEAD OF THE DEPARTMENT , PERIODONTOLOGY |
| Affiliation |
Rajiv gandhi university and health sciences |
| Address |
Bangalore institute of dental sciences and hospital
Bangalore
KARNATAKA
560029
India |
| Phone |
9844282297 |
| Fax |
|
| Email |
docranga@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arya Anil |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
Rajiv Gandhi University of Health Sciences |
| Address |
Room no.5 , Department of Periodontology ,Bangalore institute of dental sciences and hospital, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
08921523418 |
| Fax |
|
| Email |
aryaanil018@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore Institute of Dental Sciences and Hospital |
|
|
Primary Sponsor
|
| Name |
Bangalore Institute of Dental Sciences and Hospital |
| Address |
Hosur main road , Lakkasandra , Wilson garden , Bengaluru , Karnataka |
| Type of Sponsor |
Private hospital/clinic |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arya Anil |
Bangalore institute of dental sciences and hospital |
Room no . 5 , Department of Periodontology, Hosur main road , Lakkasandra , Wilson garden, Bengaluru, Karnataka
Bangalore
KARNATAKA |
08921523418
aryaanil018@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| instituitional ethical clearance committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
SRP |
SUPRA AND SUBGINGIVAL SCALING AND ROOT PLANING DONE WITH HAND SCALING INSTRUMENTS AND ULTRASONIC SCALERS |
| Intervention |
SRP AND LASER |
SUPRA AND SUBGINGIVAL SCALING ADN ROOT PLANING DONE USING HAND AND ULTRASONIC SCALING INSTRUMENTS
AFTER WHICH 810 nm LASER IS USED FOR IRRADIATING THE SELECTED PERIODONTAL POCKET FOR 60 SECONDS |
| Intervention |
SRP AND PHOTODYNAMIC THERAPY USING INDOCYANINE GREEN DYE |
SUPRA AND SUBGINGIVAL SCALING AND ROOT PLANING DONE USING HAND AND ULTRASONIC SCALING INSTRUMENTS AFTER WHICH INDOCYANINE GREEN DYE IS APPLIED WITHIN THE SELECTED PERIODONTAL POCKET FOR 30 SECONDS FOLLOWED BY IRRADIATION WITH 810 nm DIODE LASER FOR 60 SECONDS |
|
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Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.patients with minimum 20 teeth present in the oral cavity .
2. periodontal pocket depth 5-6mm in minimal 3 sites ( one in each quadrant ) |
|
| ExclusionCriteria |
| Details |
1.smokers
2.3rd molars
3.patients who have undergone periodontal therapy in last 6 months.
4.patients who have received antibiotic therapy in previous 3 months.
5.medically compromised patients
6.patients with known history of allergy
7.pregnant and lactating women |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
An Open list of random numbers |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| 1.compare and assess the microbial and biochemical parameters like BAPNA analysis on subgingival plaque samples and ELISA on GCF samples among SRP , SRP AND LASER , SRP AND PHOTODYNAMIC THERAPY groups in periodontitis patients |
0 and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess the clinical parameters like plaque index, gingival index, probing pocket depths , clinical attachment level and relative attachment level in periodontitis patients |
0 and 3 months |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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 3 |
|
Date of First Enrollment (India)
|
02/09/2022 |
| 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="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Clinical Study Report
- 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 [draryaanils21@gmail.com].
- For how long will this data be available start date provided 16-10-2023 and end date provided 16-10-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
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Brief Summary
|
Antimicrobial photodynamic therapy is being widely used in different therapeutic procedures in dentistry and medicine.’ Red complex bacteria have been seen to play a major role in controlling the biofilm in deep periodontal pockets thus having a major role in both initiation and progression of pocket depth. Indocyanine Green (ICG) offers the advantage of being active in deep pockets where these red complex bacteria’sthrive. ICG has demonstrated promising results in vitro studies specifically targeting the red complex periopathogens.Very limited studies have been done to evaluate the effect of PDT using ICG in-vivo. Serum procalcitonin is a potent marker for bacterial infections in the field of medicine. Recent articles suggest the utility of using GCF Procalcitonin levels as a marker for not just periodontal disease activity but also as an indicator for microbial activity.Hence, this novel study is designed to evaluate the effectiveness of diode laser and indocyanine green mediated photodynamic therapy as an adjunct to scaling and root planing on the red complex microflora and associated changes in GCF Procalcitonin levels in periodontitis patients. The additional microbial testing will help strengthen the decision making which was earlier based on clinical and inflammatory markers alone.
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