| CTRI Number |
CTRI/2024/12/077954 [Registered on: 11/12/2024] Trial Registered Prospectively |
| Last Modified On: |
10/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
laser Therapy as non-surgical periodontal treatment in Chronic Periodontitis patients |
|
Scientific Title of Study
|
Clinical Effectiveness of laser Therapy as an adjunct to non-surgical periodontal treatment in subjects with Chronic Periodontitis: A randomized 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 Santosh Kumar Verma |
| Designation |
Assistant Professor |
| Affiliation |
Rajendra institute of Medical Sciences, Dental Institute |
| Address |
Dept. of Periodontology,Dental Institute, Rajendra institute of Medical Sciences
Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
8002806131 |
| Fax |
|
| Email |
santoshvermakr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santosh Kumar Verma |
| Designation |
Assistant Professor |
| Affiliation |
Rajendra institute of Medical Sciences, Dental Institute |
| Address |
Dept. of Periodontology,Dental Institute, Rajendra institute of Medical Sciences
Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
8002806131 |
| Fax |
|
| Email |
santoshvermakr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Santosh Kumar Verma |
| Designation |
Assistant Professor |
| Affiliation |
Rajendra institute of Medical Sciences, Dental Institute |
| Address |
Dept. of Periodontology,Dental Institute, Rajendra institute of Medical Sciences
Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
8002806131 |
| Fax |
|
| Email |
santoshvermakr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dental Institute,
Rajendra institute of Medical Sciences, Bariatu, ranchi, jharkhand, India
pin 834009 |
|
|
Primary Sponsor
|
| Name |
Dr Santosh Kumar verma |
| Address |
Dental Institute,
Rajendra institute of Medical Sciences, bariatu, ranchi, jharkhand,India
pin 834009 |
| Type of Sponsor |
Other [silf] |
|
|
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 Santosh Kumar verma |
Dental Institute, Rajendra Institute of Medical sciences |
dept. of periodontology,
dental institute,RIMS,
Bariatu
Ranchi
Ranchi
JHARKHAND |
8002806131
santoshvermakr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RIMS Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
laser therapy |
Laser treatment protocol
Gallium –aluminium arsenide diode laser will be used with Wave length-940nm having power-0.66 W energy -15j/cm2. Technique fibre optic tip will be used coronal to apical in interdental pockets , mesial to distal in buccal pockets and Lingual/palatal pocket.
Sweeping motion will be used in each pocket with angulation -20 degree towards gingival pocket wall. Time duration will be 30 seconds each twice with 60 seconds interval at base line and 7th day of treatment. Irrigation will be done using saline after each session of treatment
|
| Comparator Agent |
scaling and root planning |
ultrasonic scaling and root planing will be done in patients with chronic periodontits. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Systemically healthysubjects with at least 20 natural teeth
2. Age group-18 years to 65 years with chronic periodontitis
3. Who have not received any treatment in last six months.
4. the presence of at least two bilateral premolars with ≥5-mm periodontal pocket depth (PPD).
5. Patients willing to participate in study
|
|
| ExclusionCriteria |
| Details |
1. patients with systemic disease, pregnant women or lactating mothers
2. Smokers
3. Use of antibiotics, analgesics, or any other medication within six months of study
4. Patients not willing to participate in the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. periodontal pocket depth
2. bleeding on probing |
0,1,3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| clinical attachment level |
0,1,3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
02/01/2025 |
| 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
|
Background: Periodontitis is a chronic inflammatory disease that affects the supporting structures of teeth, resulting in tooth loss. Nonsurgical and surgical therapies along with local and systemic antibiotic regimens have been advocated in the treatment of periodontitis. Aim: The aim of this split-mouth, double-blind, controlled clinical study is to evaluate and compare the effect of scaling and root planing alone and a combination of scaling and root planing (SRP) with diode laser therapy in patients with chronic periodontitis. Settings and Design: 30 patients with chronic periodontitis were taken from the department of periodontology and implantology, Dental College, RIMS. Materials and Methods: It is a split-mouth study and subjects will be divided into Group I – the test group (SRP + diode laser) and Group II – the control group (SRP alone). A low-level diode laser with a wavelength of 810 nm, power output 0.4 W, and energy density of 2 J/cm2 & 4 J/cm2 was applied to the gingival pocket. The following clinical parameters were assessed: oral hygiene index simplified; clinical attachment level (CAL); probing pocket depth (PPD); bleeding on probing (BOP) at baseline, 1 month, and 3 months after the treatment. Result: The data will be analyzed using Statistical Package for Social Sciences (SPSS) version 21. All the variables are continuous variables which will be summarized as mean and standard deviation. A paired t-test will be used for comparison of the mean value of 2 related samples or groups. Repeated measures of ANOVA test will be used to compare more than two related means. The level of statistical significance was set at 0.05. Keywords: Chronic Periodontitis, Gingival inflammation, Scaling and root planning, Low-level laser therapy, Non-surgical periodontal treatment. |