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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  
Status 
Not Applicable 
 
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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