Evaluation of bone formation using laser light in gum disease patients
- Conditions
- Chronic generalised periodontitis
- Registration Number
- CTRI/2018/05/013742
- Lead Sponsor
- Dr Rashmi S Pattanshetty
- Brief Summary
This will be a split mouth studywhere 15 patients, (total 45 sites) will be included. Procedure will beexplained to the patients attending outpatient section, Dept. of Periodontics, Coorg Institute of DentalSciences, Virajpet and those willing voluntarily will be enrolled for the study.His/her writtenconsent will be taken prior to commencement of the study.
INCLUSION CRITERIA:
1. Patient diagnosed with chronicperiodontitis and good systemic health.
2. 30-55 years of age.
3. Untreated chronicperiodontitis.
4. Patients with minimum of 20 number of teeth excluding third molar, with pocket
depth ≥ 5mm.
5. Each of the three quadrantshaving one periodontal pocket.
EXCLUSION CRITERIA:
1.Patients with systemic diseases (e.g., diabetes mellitus, cancer, human immuno-
deficiency virus; bone-relateddiseases 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 andocclusion.
7. Radiation or immunosuppressive therapy.
8.Patients who have undergone previous periodontal surgeries within the last 1year.
9.Patientsnot willing for treatment.
Each individual will be categorized into three groups by random allocationof 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 ofprobing pocket depth) treated by scaling and root planing and with LLLTtherapy.
(Group 3) TEST: Chronic periodontitis patients (sites having ≥ 5mm ofprobing pocket depth) treated by scaling and root planing and with diode lasertherapy.
Patients will be reviewed in series of four appointments (1, 7, 30 and 90thday). At first visit all groups will undergo scaling and root planing. Group1(control) will be on maintenance phase on 7th and 30thday.
**Laser application procedure:**
Diode laser therapy
The Periodontal pocket will be subjected to treatment with a diode laseroperating at 810 nm wavelength (1W output power, continuous wave), equippedwith a (300µ) optical fibre. Irradiation will be performed in contact mode, thefiber tip touching the pocket wall, to remove the pocket lining all around theteeth. To minimize gingival damage the tip will be moved at a constant speed of1mm/sec.
Diode laser therapy will be performed on Group 3 (Test) on days 1 and 7respectively after scaling and root planing procedure.
Low level laser therapy
Laser biostimulation (Low level laser therapy) will be done with a diodelaser operating at 810 nm wavelength (0.1W output power, continuous wave), equippedwith a (300µ) optical fibre. The fibre tip will be positioned in non-contactmode about 0.5 - 1mm away from periodontal pocket externally at right angles tolong axis of tooth in a sweeping motion all over the area starting apically andmoving upwards to coronal portion of pocket.
Low level laser therapy will be performed on Group 2 (Test) on days 1, 7and 30 respectively after scaling and root planing procedure.
CLINICAL PARAMETERS TO BE ASSESSEDARE :
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 90thday for all the groups.
COLLECTION OF SAMPLES
In all the groups, three sites per individual will be selected forsampling. Site will be gently dried with air syringe andcotton rolls, samples of GCF will be obtained by placing calibrated volumetricmicrocapillary pipettes. From each site a standardized volume of 2 microliterwill be collected. GCF sample will be collected from same site test group and control group at base linebefore treatment and on the 90th day for the assessment of osteoprotegerinconcentration in GCF. Samples will be stored in 0.5 ml of 7.4 pH phosphatebuffered saline solution.
BIOMARKER ANALYSIS
Concentration of osteoprotegerin in GCF will be determined using enzymelinked immunosorbant assay kit (ELISA) according to manufacturer’s directions.
STATISTICAL ANALYSIS :
All clinical and biochemicalparameters will be subjected to appropriate statistical analysis by eitherparametric or non-parametric tests.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 15
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the osteoprotegerin level in GCF of chronic periodontitis patients 3 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
coorg institue of dental sciences
🇮🇳Kodagu, KARNATAKA, India
coorg institue of dental sciences🇮🇳Kodagu, KARNATAKA, IndiaDr Rashmi S PattanshettyPrincipal investigator9986187860rashmi2bs@gmail.com