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CTRI Number  CTRI/2017/11/010348 [Registered on: 02/11/2017] Trial Registered Retrospectively
Last Modified On: 02/11/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Laser treatment of the gums 
Scientific Title of Study   Efficacy of Laser Assisted New Attachment Procedure(LANAP) as an adjunct to Scaling and Root Planning (SRP) in Controlled Type 2 Diabetes Mellitus Patients with Chronic Periodontitis: A Clinical and 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  Dr sourav chandra 
Designation  Post Graduate student 
Affiliation  JSS dental college and hospital 
Address  Room no 9,Department of Periodontology, JSS dental college and hospital, Mysore

Mysore
KARNATAKA
570015
India 
Phone  8105064416  
Fax    
Email  drschandra9@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pratibha Shashikumar 
Designation  Reader 
Affiliation  Jagadguru Sri Shivarathreeshwara University(JSS) 
Address  Room no 9,Department of Periodontology, JSS dental college and hospital, Mysore

Mysore
KARNATAKA
570015
India 
Phone  9986544409  
Fax    
Email  drpratibhavg@gmail.com  
 
Details of Contact Person
Public Query
 
Name  sourav chandra 
Designation  Post Graduate student 
Affiliation  JSS dental college and hospital 
Address  Room no 9,Department of Periodontology, JSS dental college and hospital, Mysore

Mysore
KARNATAKA
570015
India 
Phone  8105064416  
Fax    
Email  drschandra9@gmail.com  
 
Source of Monetary or Material Support  
JAGADGURU SRI SHIVARATHREESWARA UNIVERSITY Research Grants, ss nagar, Myore-570015 
 
Primary Sponsor  
Name  JSS University 
Address  Room no 9, department of Periodontology,JSS dental college and hospital, Mysore, Karnataka 
Type of Sponsor  Research institution and hospital 
 
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 Sourav Chandra  JAGADGURU SRI SHIVARATHREESWARA UNIVERSITY  Room no 9, Department of Periodontology, JSS dental college and Hospital,SS nagar, Mysore-570015
Mysore
KARNATAKA 
8105064416

drschandra9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  type 2 diabetic patients with chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  scaling and root planing  To study the beneficial effect of scaling and root planing in the treatment of chronic periodontitis in Type 2 Diabetes mellitus patients 
Intervention  scaling and root planing and diode laser   to study the beneficial effect of diode laser therapy over conventional scaling and root planing in the treatment of chronic periodontitis in Type 2 Diabetes mellitus patients 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Patients with confirmed diagnosis of Type 2 diabetes mellitus.
2 Generalized moderate to severe chronic periodontitis and ≥20 remaining teeth.
3 Each quadrant containing at least 3 teeth with periodontal pocket depth of 4-7mm and clinical attachment level of 2mm or greater.
4 Consenting patients who are co-operative and able to come for regular follow up.
 
 
ExclusionCriteria 
Details  1 Pregnant /lactating women.
2 Patients who are on antibiotic therapy in the previous six months.
3 Patients who have undertaken any periodontal therapy in past 6 months.
4 Smoking.
5 Alcoholism.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
improvement in clinical parameters such as plaque index, gingival index, probing depth, clinical attachment level and improvement in Glycated Haemoglobin level HbA1c  from baseline to 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
reduction in periodontal microbiology of anaerobic bacteria Aggregatibacter actinimycetemcomitans and porphyromonas gingivalis  from baseline to 3 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" 
Phase of Trial   N/A 
Date of First Enrollment (India)   29/04/2016 
Date of Study Completion (India) 10/10/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="6" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   In review process in "Journal of lasers in medical sciences" 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

SUMMARY

Periodontal therapy for the treatment of periodontitis involves the elimination of bacterial plaque. Considering the various advantages of laser irradiation, its use in combination with conventional mechanical treatment has the potential to improve the periodontal condition than mechanical therapy alone. Also, considering the evidence of bacterial invasion into the soft tissue of periodontal pockets, not only debridement of the root surface but also removal of the epithelium lining and granulation tissue of the gingival wall within periodontal pockets could be an important factor in the treatment of moderate to deep pockets in order to promote attachment of gingival connective tissue to the root surface. The present clinical study was designed to compare and evaluate the bactericidal effects of Laser Assisted New Attachment Procedure (LANAP) as an adjunct to scaling and root planing on the various clinical and microbiological parameters and the improvement in glycemic control (HbA1c) .

The primary aim of the present study was to determine the efficacy of the LANAP as an adjunct to scaling and root planing in the treatment of periodontal pockets in Type 2 Diabetes Mellitus (DM2) patients with chronic periodontitis. From  the  observations  of  the  present  study  it  can  be  suggested  that  the therapeutic effectiveness of LANAP as an adjunct to scaling and root planing is having an additional benefit over scaling and root planing alone in terms of clinical and microbiological parameters. However no statistically significant difference between two groups in terms of glycemic control was documented in this study. Added advantages of Diode laser are: better patient compliance, enhanced/ improved tissue response, greater ability to sterilize the periodontal pocket and true bactericidal potential. Thus Laser can be a useful tool in the treatment of periodontitis patients with systemic diseases.

 
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