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
|
|
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
|
|
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. |