| CTRI Number |
CTRI/2024/01/061873 [Registered on: 25/01/2024] Trial Registered Prospectively |
| Last Modified On: |
25/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Laser treatment adjunctive to non-surgical periodontal therapy |
|
Scientific Title of Study
|
Efficacy of laser activated 3% hydrogen peroxide and 2% povidone iodine as an adjunct to non-surgical periodontal therapy in stage II periodontitis patients - a randomized clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akriti Mishra |
| Designation |
Post Graduate Trainee |
| Affiliation |
AB Shetty Memorial Institute of Dental Sciences |
| Address |
ABSMIDS, 4th floor, Dept of Periodontics
Deralakatte
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7903489457 |
| Fax |
|
| Email |
drakritimishra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Avaneendra Talwar |
| Designation |
Associate Professor |
| Affiliation |
AB Shetty Memorial Institute of Dental Sciences |
| Address |
ABSMIDS, 4th floor, Dept of Periodontics
Deralakatte
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9448832799 |
| Fax |
|
| Email |
av_talwar@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Avaneendra Talwar |
| Designation |
Associate Professor |
| Affiliation |
AB Shetty Memorial Institute of Dental Sciences |
| Address |
ABSMIDS, 4th floor, Dept of Periodontics
Deralakatte
KARNATAKA
575018
India |
| Phone |
9448832799 |
| Fax |
|
| Email |
av_talwar@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| AB Shetty Memorial Institute of Dental Sciences, Karnataka |
|
|
Primary Sponsor
|
| Name |
Dr Akriti Mishra |
| Address |
AB Shetty Memorial Institute of Dental SciencesS, Dept of Periodontics, 4th floor, Deralakatte, Mangalore, Karnataka |
| 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 |
| Dr Akriti Mishra |
AB Shetty Memorial Institute of Dental Sciences |
Department of Periodontics, 4th floor
Dakshina Kannada
KARNATAKA |
7903489457
drakritimishra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, ABSMIDS |
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 |
2% povidone iodine |
photoactivation of 2% povidone iodine with 940 nm diode laser with 7 mm length and 300 um diameter uninitiated fiber tip, 1.1 W, continuous wave, exposure time for 30 sec per test surface - fiber tip will be applied from the bottom to the free gingival margin of the periodontal pocket in parallel with the root surface and side-to-side movements will be performed for 30 sec ; 2% povidone iodine solution will be inserted to the bottom of the periodontal pocket using a disposable plastic needle |
| Intervention |
3% hydrogen peroxide |
photoactivation of 3% hydrogen peroxide with 940 nm diode laser with 7 mm length and 300 um diameter uninitiated fiber tip, 1.1 W, continuous wave, exposure time for 30 sec per test surface - fiber tip will be applied from the bottom to the free gingival margin of the periodontal pocket in parallel with the root surface and side-to-side movements will be performed for 30 sec ; 3% hydrogen peroxide solution will be inserted to the bottom of the periodontal pocket using a disposable plastic needle |
| Intervention |
diode laser |
decontamination with diode 940 nm laser with 7 mm length and 300 um in diameter uninitiated fiber tip, 1.1 W, continuous wave - fiber tip will be applied from the bottom to the free gingival margin of the periodontal pocket in parallel with the root surface and side-to-side movements will be performed for 30 sec per test surface. |
| Comparator Agent |
non-surgical periodontal therapy |
scaling and root planing using ultrasonic instruments and manual Gracey curettes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. systemically healthy male or female between 18-60 years age
2. at least 20 natural teeth present in the oral cavity distributed in 4 quadrants
3. each quadrant containing at least two teeth with periodontal pocket depth (PPD) of less than or equal to 5 mm and clinical attachment loss (CAL) of 2 mm or greater
4. bleeding on probing (BOP) in all 4 quadrants |
|
| ExclusionCriteria |
| Details |
1. patients who are during active periodontal treatment or have had undergone periodontal treatment within 12 months
2. patients who have had antibiotic therapy (systemic or local) over the past 6 months
3. smokers
4. systemic conditions that may affect the therapeutic outcome (diabetes type 1 and 2, immune deficiency, hepatitis B virus, hepatitis C virus, cancer, hematological disorders, epilepsy, etc.)
5. pregnancy, breastfeeding
6. incapacity or refusal to follow the study protocol
7. severe comorbid conditions that may affect life expectancy within 1 year (e.g., metastatic cancer)
8. allergy to iodine |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Periodontal probing depth (PD)
Bleeding on probing (BOP)
Clinical attachment level (CAL) |
The markers will be evaluated at baseline (before treatment) and 3 months after treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Periodontal probing depth (PD)
Bleeding on probing (BOP)
Clinical attachment level (CAL) |
The markers will be evaluated at 1 month after intervention |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
09/02/2024 |
| 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="10"
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 - NO
|
|
Brief Summary
|
This study is designed as a randomised controlled, single-blind, single centre trial to compare the antimicrobial effect of nonsurgical periodontal therapy with SRP alone, laser activation along with SRP, photoactivation of 2% povidone iodine with 940nm diode laser in combination with SRP and photoactivation of 3% hydrogen peroxide with 940 nm diode laser in combination with SRP. The markers will be evaluated at baseline (before treatment), one month after treatment and 3 months after treatment. Periodontal probing depth (PD) Bleeding on probing (BOP) Clinical attachment level (CAL)
|