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CTRI Number  CTRI/2018/05/013742 [Registered on: 07/05/2018] Trial Registered Retrospectively
Last Modified On: 07/05/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluation of bone formation using laser light in gum disease patients 
Scientific Title of Study   COMPARATIVE EVALUATION OF OSTEOPROTEGERIN (OPG) LEVELS IN GINGIVAL CREVICULAR FLUID (GCF) IN CHRONIC PERIODONTITIS PATIENTS TREATED BY SCALING & ROOT PLANING (SRP), LOW LEVEL LASER THERAPY (LLLT) AND DIODE LASER THERAPY.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rashmi S Pattanshetty 
Designation  Post graduate student 
Affiliation  coorg institute of dental sciences 
Address  Room no 4 Department of periodontics Coorg institute of dental science virajpet
Room no 4 department of periodontics coorg institute of dental science virajpet
Kodagu
KARNATAKA
571218
India 
Phone  9986187860  
Fax    
Email  rashmi2bs@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jayaprakash GS 
Designation  Reader 
Affiliation  coorg institute of dental sciences 
Address  Room no 4 Department of periodontics Coorg institute of dental sciences virajpet
Department of periodontics Coorg institute of dental sciences virajpet
Kodagu
KARNATAKA
571218
India 
Phone  9972912662  
Fax    
Email  jayaprakashgadagi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jayaprakash GS 
Designation  Reader 
Affiliation  coorg institute of dental sciences 
Address  Room no 4 Department of periodontics Coorg institute of dental sciences virajpet
department of periodontics coorg institute of dental sciences virajpet
Kodagu
KARNATAKA
571218
India 
Phone  9972912662  
Fax    
Email  jayaprakashgadagi@gmail.com  
 
Source of Monetary or Material Support  
Coorg institute of dental sciences 
 
Primary Sponsor  
Name  Dr Rashmi S Pattanshetty 
Address  Department of Periodontics, Coorg institute of dental sciences, Virajpet 
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 Rashmi S Pattanshetty  coorg institue of dental sciences  Department of periodontis room no 4 Coorg institue of dental sciences Virajpet
Kodagu
KARNATAKA 
9986187860

rashmi2bs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Chronic generalised periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Low level laser therapy and Diode laser therapy   Low level laser therapy on 1st,7th and 30th day.Diode laser therapy on 1st,7th day 
Intervention  scaling and root planing   scaling and root planing on first visit and maintainance on subsequent visit on 7th and 30th day 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Patients diagnosed with chronic periodontitis and good systemic health
Patients with minimum of 20 number of teeth with probing depth > 5 mm, CAL> 5mm
Atleast 3 quadrants having minimum one tooth with probing depth> 5mm 
 
ExclusionCriteria 
Details  Patients with systemic diseases
Pregnant and lactating women
Smoking
Patient under certain drug therapies which effects bone metabolism
Patient who have undergone previous periodontal surgeries within last 1 year 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the osteoprotegerin level in GCF of chronic periodontitis patients  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the clinical parameters and the treatment outcome of scaling and root planing,low level laser therapy and diode laser therapy on OPG Levels in GCF of chronic periodontitis patients  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)   01/03/2018 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This will be a split mouth study where 15 patients, (total 45 sites) will be included. Procedure will be explained to the patients attending outpatient section, Dept. of Periodontics, Coorg Institute of Dental Sciences, Virajpet and those willing voluntarily will be enrolled for the study. His/her written consent will be taken prior to commencement of the study.

 

INCLUSION CRITERIA:

1. Patient diagnosed with chronic periodontitis and good systemic health.

2. 30-55 years of age.

3. Untreated chronic periodontitis.

4. Patients  with  minimum  of  20  number  of  teeth  excluding  third  molar,   with   pocket

    depth ≥ 5mm.

5. Each of the three quadrants having one periodontal pocket.

 

EXCLUSION CRITERIA:

1. Patients   with   systemic   diseases   (e.g.,  diabetes  mellitus,   cancer,   human  immuno- 

    deficiency virus; bone-related diseases and collagen-metabolic diseases or disorders).

2. Pregnant and lactating women.

3. Smoking within the past 5 years.

4. Patients under certain drug therapies which effects bone metabolism.

5. Periapical pathologies.

 

6. Excessive forces including mechanical forces from orthodontics and occlusion.

7. Radiation or immunosuppressive therapy.

8. Patients who have undergone previous periodontal surgeries within the last 1 year.

9. Patients not willing for treatment.

 

Each individual will be categorized into three groups by random allocation of three quadrants of mouth.

 

(Group 1)  CONTROL:  Chronic periodontitis patients (sites having ≥ 5mm of probing pocket depth) treated by scaling and root planing alone.                   

 

(Group 2) TEST: Chronic periodontitis patients (sites having ≥ 5mm of probing pocket depth) treated by scaling and root planing and with LLLT therapy.

 

(Group 3) TEST: Chronic periodontitis patients (sites having ≥ 5mm of probing pocket depth) treated by scaling and root planing and with diode laser therapy.

 

Patients will be reviewed in series of four appointments (1, 7, 30 and 90th day). At first visit all groups will undergo scaling and root planing. Group1 (control) will be on maintenance phase on 7th and 30th day.

 

Laser application procedure:

Diode laser therapy

The Periodontal pocket will be subjected to treatment with a diode laser operating at 810 nm wavelength (1W output power, continuous wave), equipped with a (300µ) optical fibre. Irradiation will be performed in contact mode, the fiber tip touching the pocket wall, to remove the pocket lining all around the teeth. To minimize gingival damage the tip will be moved at a constant speed of 1mm/sec.

Diode laser therapy will be performed on Group 3 (Test) on days 1 and 7 respectively after scaling and root planing procedure.

 

Low level laser therapy

Laser biostimulation (Low level laser therapy) will be done with a diode laser operating at 810 nm wavelength (0.1W output power, continuous wave), equipped with a (300µ) optical fibre. The fibre tip will be positioned in non-contact mode about 0.5 - 1mm away from periodontal pocket externally at right angles to long axis of tooth in a sweeping motion all over the area starting apically and moving upwards to coronal portion of pocket.

Low level laser therapy will be performed on Group 2 (Test) on days 1, 7 and 30 respectively after scaling and root planing procedure.

 

CLINICAL PARAMETERS TO BE ASSESSED ARE :

  1. Gingival index (Loe & Sillness 1963)
  2. Bleeding index (Muhlemann & son 1971)
  3. Probing pocket depth (PPD) using UNC 15probe standardized by using customized acrylic stent.
  4. Clinical attachment level (CAL) using UNC 15 probe standardized by using customized acrylic stent.

Clinical parameters will be assessed at baseline and on 90th day for all the groups.

 

COLLECTION OF SAMPLES

In all the groups, three sites per individual will be selected for sampling. Site will be gently dried with air syringe and cotton rolls, samples of GCF will be obtained by placing calibrated volumetric microcapillary pipettes. From each site a standardized volume of 2 microliter will be collected. GCF sample will be collected from same site test group and control group at base line before treatment and on the 90th day for the assessment of osteoprotegerin concentration in GCF. Samples will be stored in 0.5 ml of 7.4 pH phosphate buffered saline solution.

 

BIOMARKER ANALYSIS

Concentration of osteoprotegerin in GCF will be determined using enzyme linked immunosorbant assay kit (ELISA) according to manufacturer’s directions.

 

STATISTICAL ANALYSIS :

All clinical and biochemical parameters will be subjected to appropriate statistical analysis by either parametric or non-parametric tests.

 
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