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CTRI Number  CTRI/2019/12/022223 [Registered on: 03/12/2019] Trial Registered Prospectively
Last Modified On: 26/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study comparing the effects of light therapy and an antibiotic-Minocycline gel on the levels of a certain microorganism present in patients with gum diseases 
Scientific Title of Study   A RANDOMIZED CONTROL TRIAL COMPARING THE EFFICACY OF MINOCYCLINE AS LOCAL DRUG DELIVERY AND DIODE LASER DEBRIDEMENT ON THE LEVELS OF PORPHYROMONAS GINGIVALIS IN CHRONIC PERIODONTITIS:A CLINICO MICROBIOLOGICAL STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrSneha Fal Dessai 
Designation  Post graduate student 
Affiliation  Coorg Institute Of Dental Sciences 
Address  Department Of Periodontics Coorg Institute Of Dental Sciences KK Campus Coorg District Virajpet

Kodagu
KARNATAKA
571218
India 
Phone  9483925940  
Fax    
Email  snehafaldessai9@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrKrishnaraj GN 
Designation  Professor 
Affiliation  Coorg Institute Of Dental Sciences 
Address  Department Of Periodontics Coorg Institute Of Dental Sciences KK Campus Coorg District Virajpet

Kodagu
KARNATAKA
571218
India 
Phone  7259456314  
Fax    
Email  dentalsolutions@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrKrishnaraj GN 
Designation  Professor 
Affiliation  Coorg Institute Of Dental Sciences 
Address  Department Of Periodontics Coorg Institute Of Dental Sciences KK Campus Coorg District Virajpet

Kodagu
KARNATAKA
571218
India 
Phone  7259456314  
Fax    
Email  dentalsolutions@gmail.com  
 
Source of Monetary or Material Support  
Coorg Institute Of Dental Sciences Coorg Instituite of Dental Sciences, K.K.Campus, Maggula Village, Virajpet Coorg District Karnataka Pin: 571218 
 
Primary Sponsor  
Name  Dr Sneha Fal Dessai 
Address  Department of Periodontics Coorg Institute of Dental Sciences KK Campus Maggula village Virajpet Kodagu District Karnataka 571218 
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 Sneha Fal Dessai  Coorg Institute of Dental Sciences  Department Of Periodontics and Implantology,Department No-4
Kodagu
KARNATAKA 
9483925940

snehafaldessai9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board Coorg Institute Of Dental Science  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Chronic Generalised Periodontitis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Diode LASER therapy  One quadrant will receive the laser therapy using 980 nm Diode LASER on the 1st, 3rd and the 7th day after scaling and root planing. 
Intervention  Minocycline  2% Minocycline Gel application after scaling and root planing in the other quadrant.The gel application will be repeated at two and four weeks after scaling and root planing in the test sites,according to the manufacturer’s instructions. 
Comparator Agent  Scaling and Root Planing  Debridement of supragingival and subgingival calculus 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients with probing depth of greater than 4mm
Patients suffering from chronic periodontitis without any medical history.
No history of smoking
No periodontal treatment within the previous 6 month



 
 
ExclusionCriteria 
Details  Pregnant ladies, lactating mothers were excluded from the study.
Patients on anti-inflammatory and steroid therapy within the last three months.
History of any systemic diseases.
Use of hormonal contraceptives.

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Expecting reduction in the number of levels of Porphyromonas Gingivalis along with reduction in Sulcus Bleeding Index,Plaque Index,Probing Pocket depth and Clinical Attachment Levels.   Baseline and Three Months 
 
Secondary Outcome  
Outcome  TimePoints 
Gradual reduction in the number of levels of Porphyromonas Gingivalis along with reduction in Sulcus Bleeding Index,Plaque Index,Probing Pocket depth and Clinical Attachment Levels.   Baseline and Three months 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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 1 
Date of First Enrollment (India)   07/12/2019 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Chronic periodontitis is an infectious disease resulting in inflammation within the supporting tissues of the teeth, progressive attachment loss, and bone loss.The role of Porphyromonas gingivalis is well established in the development and pathogenesis of periodontitis.Minocycline acts by interfering with protein synthesis in the bacterial cell wall along with its anti-collagenase effect.Diode laser accelerates wound healing, promotes angiogenesis and also augments growth factor release.

This Randomized Clinical Trial protocol is designed as a split mouth single masked clinical trial of 12 weeks duration simulating the treatment flow of conventional periodontal therapy. After qualifying for the study, 15 patients age ranging from 30-65 years will be enrolled and 4 clinical variables along with the microbiological samples will be evaluated at the baseline by one examiner who will be recording all measurements in a single blind design. This will include Sulcus Bleeding Index (SBI)Plaque Index (PI), Probing Pocket depth (PPD), Clinical Attachment Level (CAL) along with subgingival plaque samples for Porphyromonas Gingivalis. Full mouth scaling and root planing will be performed at baseline appointment following initial examination.One quadrant will receive the diode laser therapy on the 1st, 3rd and the 7th day after scaling and root planing. The other will receive minocycline gel application after scaling and root planing and the gel application will be repeated at two and four weeks in the test sites, according to the manufacturer’s instructions.Subgingival plaque samples will be collected at baseline, and at three month intervals. Sterile periodontal curette will be used for collection of subgingival plaque samples.For sample collection the teeth surfaces will be dried with sterile gauze to avoid contamination by saliva. Sub gingival plaque samples will be collected from deepest periodontal pockets using sterile periodontal curette and assessed for the microbial load using Polymerase chain reaction

This study is done to compare the efficacy of minocycline as local drug delivery and diode laser debridement and also to evaluate the levels of Porphromonasgingivalisin chronic periodontitis patients.

 

 
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