CTRI Number |
CTRI/2025/05/087657 [Registered on: 26/05/2025] Trial Registered Prospectively |
Last Modified On: |
26/05/2025 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
Laser therapy for Periodontitis. |
Scientific Title of Study
|
Effect of Adjunctive Low level laser Therapy on GCF levels of tissue Plasminogen Activator and Periodontal Inflammatory Burden in Periodontitis. |
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 Veena H R |
Designation |
Professor |
Affiliation |
KLE Societys Institute of Dental Sciences |
Address |
Room no 05 Department of Periodontics KLE Societys Institute of Dental Sciences 20 Yeshwanthpur suburb 2nd stage Tumkur Road Bangalore 560022
Bangalore KARNATAKA 560022 India |
Phone |
9480516011 |
Fax |
|
Email |
drveenahr@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Veena H R |
Designation |
Professor |
Affiliation |
KLE Societys Institute of Dental Sciences |
Address |
Room no 05 Department of Periodontics KLE Societys Institute of Dental Sciences 20 Yeshwanthpur suburb 2nd stage Tumkur Road Bangalore 560022
KARNATAKA 560022 India |
Phone |
9480516011 |
Fax |
|
Email |
drveenahr@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Amruta Prakash Koparde |
Designation |
Post graduate student |
Affiliation |
KLE Societys Institute of Dental sciences |
Address |
Room no 05 Department of Periodontics KLE Societys Institute of Dental Sciences 20 Yeshwanthpur suburb 2nd stage Tumkur Road Bangalore 560022
Bangalore KARNATAKA 560022 India |
Phone |
9901068784 |
Fax |
|
Email |
shobhakop50@gmail.com |
|
Source of Monetary or Material Support
|
KLE Societys Institute of Dental Sciences No 20 Yeshwanthpur suburb Opp CMTI Tumkur Road Bangalore 560022 |
RGUHS Research Grant Fund
Rajiv Gandhi University of Health Sciences Karnataka 4th T Block Jayanagar Bangalore 560041 |
|
Primary Sponsor
|
Name |
RGUHS Research Grant |
Address |
Rajiv Gandhi University of Health Sciences 4th T block Jayanagar Bangalore 560041 |
Type of Sponsor |
Research institution |
|
Details of Secondary Sponsor
|
Name |
Address |
KLE Societys Institute of Dental Sciences |
KLE Societys Institute of Dental Sciences 20 Yeshwanthpur suburb 2nd stage, Tumkur road Bangalore 560022 |
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Veena H R |
KLE Societys Institute of Dental Sciences |
Room no 05 Department of Periodontics KLE Societys Institute of Dental Sciences No 20 Yeshwanthpur suburb 2nd stage Tumkur Road Bangalore 560022 Bangalore KARNATAKA |
9480516011
drveenahr@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
KLE Societys Institute of Dental Sciences Communication of Decision of the Institutional Ethics Committee |
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 |
Scaling and root planing followed by low level laser therapy |
Recording of clinical parameters,calculation of PISA and collection of GCF sample at Baseline and 3 months followup. Two sessions of full mouth Scaling and root Planing(after evaluation and 7 days after the first session) using hand and ultrasonic instruments followed by Low Level Laser Therapy using 660nm diode laser(immediately after the completion second session of scaling and root Planing and 1 week later) for all subjects of group 2.
|
Comparator Agent |
Scaling and Root Planing followed by Sham Low Level Laser Therapy |
Recording of clinical parameters,calculation of PISA and collection of GCF sample at Baseline and 3 months followup. Two sessions of full mouth Scaling and root Planing(after evaluation and 7 days after the first session) using hand and ultrasonic instruments followed by Sham Low Level Laser Therapy using 660nm diode laser without turning on the light(immediately after the completion second session of scaling and root Planing and 1 week later) for all subjects of group 1. |
|
Inclusion Criteria
|
Age From |
30.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
Patients of both genders diagnosed with generalised periodontitis stage 3 grade B, in the age group of 30 to 50 years with good systemic health.
Presence of a minimum of 20 teeth.
|
|
ExclusionCriteria |
Details |
Patients who underwent periodontal therapy during the previous 6 months of commencement of the study.
Subjects on antibiotics or immunosuppressant medication 6 months prior to the study.
Chronic Smokers, Alcoholics, Smokeless tobacco users.
Subjects with acute illnesses/acute intraoral lesions.
Pregnant subjects.
Medically compromised subjects.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Decrease in the Gingival Crevicular Fluid levels of Tissue Plasminogen Activator following application of Low Level Laser Therapy along with Scaling and Root Planing compared to Scaling and Root Planing alone. |
Baseline and 3 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Periodontal Inflamed Surface Area (PISA)
Probing Pocket Depth (PPD)
Clinical Attachment Level (CAL)
Location of Gingival Margin (LGM)
No. of Sites with Bleeding on Probing (BOP)
|
Baseline and 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)
|
12/06/2025 |
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="0" Months="3" 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
|
INTRODUCTION: Periodontitis is a chronic inflammatory disease resulting from an interplay between microbial plaque and the host immune-inflammatory response. The identification of specific biomarkers in the gingival crevicular fluid (GCF) can be correlated with the biologic processes including inflammation, connective tissue degradation and bone turnover and hence offer the potential to be used as diagnostic or prognostic markers of periodontal disease and treatment outcome. The primary goal of-nonsurgical periodontal therapy is to establish a periodontium that is in remission of periodontal disease. Although the gold standard of periodontal therapy till date is scaling and root planing (SRP), the use of more efficient and less traumatic adjunctive therapeutic modalities like lasers, may provide long lasting therapeutic benefits. Low level Laser therapy (LLLT), a new era in laser technology uses laser light at low levels with the intention to reduce inflammation and enhance wound healing. Enzymes such as tissue plasminogen activator (tPA) are responsible for regulating the local inflammatory reactions as well as the synthesis of specific extracellular matrix molecules by fibroblasts, angiogenesis and re-epithelization that occur during tissue repair and remodelling. The periodontal inflamed surface area (PISA) is a very convenient index that reflects the surface area of bleeding pocket epithelium in square millimetres and is calculated using conventional clinical parameters of periodontal health, namely number of sites with Bleeding on probing (BOP) combined with Probing Pocket Depth (PPD),Clinical Attachment Level (CAL) and Location of Gingival Margin(LGM). These values are entered in a freely downloadable spreadsheet available on parsprototo.info website to calculate the PISA value.
AIM: To investigate the effects of LLLT as an adjunct to non- surgical periodontal treatment by evaluating tPA levels in the gingival crevicular fluid levels and periodontal inflammatory burden in patients with periodontitis. OBJECTIVE: To evaluate and compare the effects of SRP with and without adjunctive LLLT in the management of periodontitis on GCF levels of tPA and the periodontal inflamed surface area (PISA). METHODOLOGY: The study will follow a parallel arm, randomised, placebo controlled design. After obtaining a written informed consent, a total of 30 volunteering patients fulfilling the inclusion criteria will be categorized into two treatment groups with 15 patients in each by simple random method using computer generated table. The two groups will be: • Group 1 - SRP(after evaluation and 7 days after the first session)+sham LLLT(immediately after the completion second session of SRP and 1 week later) • Group 2- SRP(after evaluation and 7 days after the first session)+LLLT (immediately after the completion second session of SRP and 1 week later). All patients will be subjected to full-mouth periodontal examination. Clinical parameters will be recorded, PISA will be calculated and GCF samples will be collected at baseline and 3 months after treatment from atleast 3 non adjacent sites with highest PPD eluted in phosphate buffer saline and stored in -20 °C until the assay. LLLT will be applied 0.5mm -1mm away from gingival margin using 660nm diode laser for 20s over each surface covering the oral cavity for group 2 and Sham LLLT application is done using 660nm diode laser without turning on the lights for group 1. The tPA levels in GCF will be quantified using commercially available ELISA kit specific for tPA.
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