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CTRI Number  CTRI/2024/03/064817 [Registered on: 27/03/2024] Trial Registered Prospectively
Last Modified On: 24/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Blue Laser and Antibiotics in the treatment of Periodontitis 
Scientific Title of Study   Comparative analysis of the antimicrobial effect of Low Level Light Therapy versus Systemic Antimicrobials as an adjunct in the non surgical treatment of Stage 3 & 4 Periodontitis A Procalcitonin guided randomised controlled 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  Benedicta Theresa Abraham 
Designation  Post Graduate Department of Periodontology 
Affiliation  Bangalore Institute of Dental Sciences and Hospital 
Address  Department of Periodontology, room no 5, Bangalore Institute of Dental Sciences and Hospital 5/3 Hosur Main Road Lakkasandra Wilson Garden Bangalore 560027

Bangalore
KARNATAKA
560027
India 
Phone  9448741997  
Fax    
Email  benedicta2846@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr S Srirangarajan 
Designation  Head of Department Department of Periodontology 
Affiliation  Bangalore Institute of Dental Sciences and Hospital 
Address  Bangalore Institute of Dental Sciences and Hospital 5 3 Hosur Main Road Lakkasandra Wilson Garden Bangalore 560027


KARNATAKA
560027
India 
Phone  9844292297  
Fax    
Email  docranga@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Benedicta Theresa Abraham 
Designation  Post Graduate Department of Periodontology 
Affiliation  Bangalore Institute of Dental Sciences and Hospital 
Address  Department of Periodontology room no 5 Bangalore Institute of Dental Sciences and Hospital 5 3 Hosur Main Road Lakkasandra Wilson Garden Bangalore 560027


KARNATAKA
560027
India 
Phone  9448741997  
Fax    
Email  benedicta2846@gmail.com  
 
Source of Monetary or Material Support  
Department of Periodontology, room no 5, Bangalore Institute of Dental Sciences and Hospital 5/3 Hosur main road, Lakkasandra, Wilson Garden, Bangalore 560027 
 
Primary Sponsor  
Name  Benedicta Theresa Abraham 
Address  Bangalore Institute of Dental Sciences and Hospital 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Benedicta Theresa Abraham  Bangalore Institute of Dental Sciences and Hospital  Department of Periodontology, room no 5, Bangalore Institute of Dental Sciences and Hospital Hosur main road, Lakkasandra, Wilson Garden Bangalore 560027
Bangalore
KARNATAKA 		 9448741997

benedicta2846@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Clearance Committee of Bangalore Institute of Dental Sciences and Hospital  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 
Comparator Agent  Low Level Laser Therapy  400-500nm blue light laser with power outputs ranging from 50-500mW will be used after scaling and root planing using ultrasonic scaler and hand instruments. The laser tip will be placed within the sulcus of the tooth and will be moved circumferentially around the tooth for 20 seconds. This will be done once for all teeth 
Intervention  Non surgical periodontal therapy  full mouth scaling and root planing in one session using a combination of ultrasonic scaler and hand scaling instruments 
Comparator Agent  Systemic antimicrobials  After scaling and root planing using ultrasonic scaler and hand instruments, 250mg Tetracycline, four times a day for two days will be prescribed. 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Age: 45 -60yrs
2. Stage 3 & Stage 4 Periodontitis patients
(According to AAP & EFP 2017 Classification)
3. Minimum of 20 teeth, excluding third molars to be present.
 
 
ExclusionCriteria 
Details  1. Any systemic or debilitating disease affecting periodontal health.
2. Immunocompromised patients
3. Regular NSAIDS and Aspirin use
4. Regular anti-inflammatory medication use
5. Antimicrobial use in the last three months
6. Antimicrobial mouthwash use in the last three months
7. Surgical periodontal treatment in the last three months
8. Pregnant or lactating women
9. Former or current smokers
10. Former or current alcoholics
11. Active carious lesions
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Serum Procalcitonin, Serum CRP  Baseline, 4 weeks and 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Plaque index, Gingival index,Probing pocket depth, CAL, RAL  baseline, 1 month, 3 months 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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 
Date of First Enrollment (India)   08/04/2024 
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 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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [benedicta2846@gmail.com].

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Periodontitis is a chronic infectious disease, in which the microbial biofilm plays a significant role, resulting in inflammation within the supporting tissues of the teeth and if left untreated, will ultimately lead to tooth loss. The management centers on the mechanical disruption of the biofilm and systemic antimicrobials. However, there are significant limitations to antimicrobial therapy, especially multidrug resistance, patient compliance, overt use of antimicrobials and poor efficacy against the biofilm. The objectives of this study is to determine the CRP and PCT levels in Periodontitis Stage 3 and Stage 4 patients. To evaluate the reduction in CRP and PCT levels after Non Surgical Periodontal Therapy (NSPT), NSPT + adjunctive antimicrobials, NSPT + adjunctive LLLT and to compare the reduction in CRP and PCT levels among the three groups. Participants will be grouped into two groups- Group 1- Periodontally Healthy Group (Control) (n=16) and Group 2- Periodontitis Stage 3 and 4 Group (Test) (n=48).  Standardized serum samples will be collected from both groups to determine the values of CRP and PCT. Only Group 2, treatment group participants whose PCT values >0.25ng/mL will be included in the interventional randomized control trial. Standardized sub-gingival plaque samples from Group 2 participants will be collected for microbial analysis. Group 2 participants will be further sub grouped into three subgroups based on the interventions- A) NSPT (n=16), B) NSPT along with systemic antimicrobials (n=16), C) NSPT along with Low Level Light Therapy (n=16). A 400-500nm blue light source with power outputs ranging from 50-500mW, equipped with a probe tip will be used. It will be placed at the depth of the pocket and moved circumferentially around the tooth.
 
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