| CTRI Number |
CTRI/2019/11/022143 [Registered on: 26/11/2019] Trial Registered Prospectively |
| Last Modified On: |
27/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare a substance in gum fluids of smokers and non-smokers with gum disease before and after treatment with and without red light therapy. |
|
Scientific Title of Study
|
A randomized controlled trial comparing the effect of low level laser therapy as an adjunct to scaling and root planing on MMP-8 levels in smoking and nonsmoking patients with chronic periodontitis – A clinico biochemical study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Parikshith H M |
| Designation |
Post graduate student |
| Affiliation |
Coorg Institute Of Dental Sciences |
| Address |
Room no 4, Department of Periodontics and Implantology, Coorg institute of dental sciences, Kanjithanda Kushalappa campus, Maggula village, Virajpet, Kodagu
Kodagu
KARNATAKA
571218
India |
| Phone |
8277753340 |
| Fax |
|
| Email |
parikshith.gowda@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Walvekar |
| Designation |
Professor and HOD |
| Affiliation |
Coorg Institute Of Dental Sciences |
| Address |
Room no 4, Department of Periodontics and Implantology, Coorg institute of dental sciences, Kanjithanda Kushalappa campus, Maggula village, Virajpet, kodagu
Kodagu
KARNATAKA
571218
India |
| Phone |
9480085687 |
| Fax |
|
| Email |
amitakw@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Walvekar |
| Designation |
Professor and HOD |
| Affiliation |
Coorg Institute Of Dental Sciences |
| Address |
Room no 4, Department of Periodontics and Implantology, Coorg institute of dental sciences, Kanjithanda Kushalappa campus, Maggula village, Virajpet, kodagu
Kodagu
KARNATAKA
571218
India |
| Phone |
9480085687 |
| Fax |
|
| Email |
amitakw@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontics and Implantology, Coorg institute of dental sciences, Virajpet Kodagu Karnataka, 571218 |
|
|
Primary Sponsor
|
| Name |
Dr Parikshith H M |
| Address |
Department of Periodontics and Implantology, Coorg institute of dental sciences, Virajpet Kodagu Karnataka, 571218 |
| Type of Sponsor |
Other [Self] |
|
|
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 Parikshith H M |
Coorg Institute of Dental Sciences |
Department of Periodontics and Implantology,Room no 4, Kanjithanda Kushalappa campus, Maggula village, Virajpet, Kodagu
Kodagu
KARNATAKA |
8277753340
parikshith.gowda@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Chronic Periodontitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LASER |
Diode LASER 810nm |
| Comparator Agent |
Scaling and Root planing |
Debridement of supra gingival and sub gingival calclus |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with chronic periodontitis.
Subjects with periodontal pocket ≤10mm.
Subjects who are current smokers (≥ 10 cigarettes/day) and nonsmokers.
|
|
| ExclusionCriteria |
| Details |
Subjects with any systemic disease.
Subjects who have undergone any periodontal treatment in the last 6 months.
Subjects who have received antibiotics/anti-inflammatory drugs/steroids in the recent past
Pregnant or lactating women.
Subjects with teeth mobility of grade III.
Subjects with periodontal pockets greater than 10mm.
Subjects who are current smokers and smoke less than 10 cigarettes per day.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Expecting reduction in Probing Pocket Depth, gain in Clinical Attachment Level and reduction in MMP - 8 levels in gingival crevicular fluid |
Baseline, 1 month and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gradual reduction of Probing pocket depth, increase in Clinical attachment level and Gradual reduction in MMP - 8 levels. |
Baseline, 1 month and 3 months |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
Final Enrollment numbers achieved (Total)= "16"
Final Enrollment numbers achieved (India)="16" |
Phase of Trial
Modification(s)
|
N/A |
|
Date of First Enrollment (India)
|
09/12/2019 |
| Date of Study Completion (India) |
29/05/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Periodontitis is a highly prevalent inflammatory disease in tooth supporting tissues, induced by bacteria growing in a biofilm on tooth surfaces. Conventional periodontal therapy includes surgical and non-surgical approaches that involve instrumentation of inflamed dentogingival complex. Low level laser therapy (LLLT) has been widely applied in reducing inflammation. Research indicates that LLLT induces an anti-inflammatory effect that may enhance periodontal disease therapy. Smoking is an independent risk factor for initiation, extent and severity of periodontal disease. This study is done to evaluate the effect of LLLT as an adjunct to non-surgical periodontal therapy in smoking and nonsmoking patients with chronic periodontitis. A total of 16 patients including males and females, with chronic periodontitis aged between 30-65 years are included in the study. The proposed study will be explained to each of the selected patients and his/her written consent will be obtained prior to the commencement of the study. The demographic characteristics of the patients (age and sex), clinical parameters will be recorded initially. All the patients in the study will be divided into two groups (Group-A and Group-B) based on their smoking habits. Group-A consists of current smokers (≥10 cigarettes/day) and group-B consists of non-smoker patients. 4 clinical variables will be evaluated at the baseline by one examiner who will be recording all measurements in a single blind design including Plaque Index (PI), Sulcus Bleeding Index (SBI), Probing Pocket depth (PPD), Clinical Attachment Level (CAL). The study will be done in a split mouth design in both groups, where two quadrants will receive Scaling and Root Planing (SRP) and the other two quadrants will receive LLLT as an adjunct to SRP. LLLT will be done on 1st, 7th and 21st day. Gingival crevicular fluid will be collected from the deepest periodontal pocket in both SRP and LLLT as an adjunct to SRP sites. GCF samples will be collected using micro-capillary pipettes at baseline, 1st and 3rd month after treatment for assessment of MMP-8 levels. The assessment of MMP-8 levels will be done using Enzyme Linked Immuno Sorbant Assay (ELISA). Clinical parameters will also be recorded at the same time intervals.
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