| CTRI Number |
CTRI/2024/03/064541 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
23/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Laser with Full-mouth Disinfection in Periodontitis Patients. |
|
Scientific Title of Study
|
Evaluation of Effectiveness of Diode Laser as an Adjunct to One-stage Full-mouth Disinfection in stage II Periodontitis: A clinical 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 Sneha Dare |
| Designation |
Post graduate student, Dept. of Periodontics and Implantology |
| Affiliation |
|
| Address |
Room no. 003, Ground floor, Department of Periodontics, Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe)
Wardha
MAHARASHTRA
442001
India |
| Phone |
7719075663 |
| Fax |
|
| Email |
snehadare3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pavan Bajaj |
| Designation |
Associate Professor |
| Affiliation |
Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe) |
| Address |
003, Department of Periodontics, Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe)
Wardha
MAHARASHTRA
442001
India |
| Phone |
08412045019 |
| Fax |
|
| Email |
pavbajaj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pavan Bajaj |
| Designation |
Associate Professor |
| Affiliation |
Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe) |
| Address |
Room no. 003, Ground floor, Department of Periodontics, Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe)
Wardha
MAHARASHTRA
442001
India |
| Phone |
08412045019 |
| Fax |
|
| Email |
pavbajaj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha |
|
|
Primary Sponsor
|
| Name |
Sharad Pawar Dental College, Sawangi (Meghe) |
| Address |
Sawangi Meghe,Wardha |
| Type of Sponsor |
Private medical college |
|
|
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 Sneha Dare |
Sharad Pawar Dental College, Sawangi (Meghe) |
Room no. 003, Ground floor, Department of Periodontics, Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe)
Wardha
MAHARASHTRA |
7719075663
snehadare3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, (2) ICD-10 Condition: K056||Periodontal disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Diode Laser |
After completion of Full-mouth Disinfection periodontal pockets will be irradiated by Diode Laser by placing into periodontal pocket and moving in one swipe motion. |
| Comparator Agent |
Full-mouth Disinfection using Chlorhexidine |
Conventional Full-mouth Disinfection using Chlorhexidine |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Generalized interproximal attachment loss involving at least three teeth apart from molars and ï¬rst incisors.
2. Amount of microbial deposits inconsistent with the severity of periodontal tissue destruction.
3. Patients with a minimum number of 20 teeth.
4. Patients with clinical attachment loss and probing depths (PDs) ≥ 4 mm at 2 sites of a minimum of 12 teeth.
5. The patients included in the study should be systemically healthy.
6. Patients with no history of periodontal therapy in the preceding 6 months or under any antibiotic therapy.
7. Patients motivated to have the therapy and willing to complete the follow-up.
|
|
| ExclusionCriteria |
| Details |
1. Patients with a known or suspected allergy
2. Patients who have undergone periodontal therapy in the last 6 months.
3. Patients with any systemic disorder affecting periodontal health.
4. Patients with infectious conditions other than periodontitis.
5. Chronic alcoholics
6. Patients consuming tobacco in any form and smokers.
7. Immuno-compromised and systemically-unhealthy patients.
8. Pregnant or lactating females.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Diode Laser irradiation adjunct to Full-mouth disinfection may lead to better outcomes. |
Outcome will be assessed at 3 months & 6 months. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
15/04/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Full-mouth disinfection is a treatment method for periodontitis. The aim
of this treatment is to manage periodontal pockets by preventing infection of
periodontal pathogens and intraoral bacterial reservoirs, such as tonsils,
tongue, and other mucous membranes, that could lead to a disease recurrence. In
this method, the entire mouth is disinfected in a single session, which
includes scaling and root planing (SRP) and the use of antimicrobial agents
such as chlorhexidine (CHX). In this study, 36 patients will be equally distributed in two different groups. Group A (n=18) will be alloted with conventional Full-mouth disinfection(FMD) and Group B(n=18) will undergo Diode Laser irradiation adjunt to conventional FMD. Expected outcomes will be the group with adjunct Diode Laser irradiation will give better results. |