To compare & evaluate the outcome of surgery using laser or blade for gum disease.
- Conditions
- Chronic periodontitis,
- Registration Number
- CTRI/2023/05/053334
- Lead Sponsor
- MGM Dental College and Hospital Kamothe Navi Mumbai
- Brief Summary
The study design would be single centric, prospective, clinical, randomized split mouth, interventional study. Which would involve single rooted teeth, involve maxillary non- adjacent anterior teeth or adjacent teeth not crossing midline, affected by periodontitis with evidence of Horizontal probing depth of more than 4mm with radiographic evidence of bone loss. Participants will be treated by two interventions Laser sulcus de-epithelization on one side and on another side gingival curettage by excisional new attachment procedure.
Group A – ENAP with surgical blade following SRP
Group B – sulcus de - epithelization with diode laser following SRP.
Group A sites will be treated by gingival curettage by excisional new attachment procedure. Excisional new attachment procedure performed with surgical blade no 15.
Group B sites will be treated using diode laser sulcus de - epithelization using 810 nm wavelength and 2-watt laser, continues, pulsed mode, diameter of optic fiber tip is 3 mm with initiated, hot tip in contact, non – pulsed mode, in apico- coronal directions.
Clinical parameters change probing depth , clinical attachment level, gingival index, sulcus bleeding index measured at baseline , 6 week and 12 weeks .
At 1st visit – (Impressions will be taken) stent preparation to fixed reference point.
At 2nd visit charting done from fixed reference points .Scaling and root planning will be done.
Patients will be treated on one side with ENAP and on other side LSDE .Post operative instructions will be given and patient will be prescribed mouthwash and analgesic.
At 3rd visit pack removal will be done which is after 1 week of 2nd visit.
At 4th visit which will be after 3 weeks of 3rd visit ,Charting recorded from above mentioned fixed reference points. At 5th visit which will be after 6 weeks after 4th visit. Charting recorded from above mentioned fixed reference points.
**Statistical analysis:** Data collected will be compiled on to a MS Office excel worksheet & will be subjected to statistical analysis using an appropriate package like SPSS software. Descriptive statistics like frequency (n) & percentage (%) of categorical data, mean & Standard deviation of numerical data in each time interval will be depicted.
Normality of numerical data will be checked using Shapiro – Wilk test or Kolmogorov-Smirnov test. Depending on the normality of data, statistical tests will be determined.
Inter and Intra group comparisons (split mouth design) for a numerical continuous data following a normal distribution will be done using paired t test (for 2 observations) or repeated measures ANOVA for >2 observations, else a non-parametric substitute like Wilcoxon signed rank test (for 2 observations) or Friedman’s test for >2 observations will be used.
Keeping alpha error at 5% and Beta error at 20%, power at 80%, p<0.05 will be considered statistically significant.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 50
- 1.Systemically healthy patients within age group 18 yrs to 60 yrs who are willing to participate .
- Two non- adjacent Periodontally involved non-adjacent teeth crossing the midline teeth anterior to premolar affected by periodontitis with probing pocket depth of above 4 mm and radiographic evidence of horizontal bone loss.
- Patients who have Diabetic mellitus, hypertension 2.
- Pregnant, nursing mothers 3.
- Patients who have taken systemic antimicrobials during the last 3 months 4.
- Smokers, alcoholic and tobacco chewers.
- History of periodontal therapy in last 6 months.
- Radiographic evidence of vertical bone loss.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate & compare the clinical outcomes assessed through change in probing depth, change in clinical attachment level, change in apparent position of gingiva, & width of attached gingiva by intervention with either excisional new attachment procedure or diode laser assisted Clinical outcomes evaluated at baseline ,6 weeks & 12 weeks from baseline sulcus de-epithelization following root debridement in treatment of periodontitis assessed at baseline ,6 weeks & 12 weeks . Clinical outcomes evaluated at baseline ,6 weeks & 12 weeks from baseline
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
MGM Dental College and Hospital
🇮🇳Mumbai, MAHARASHTRA, India
MGM Dental College and Hospital🇮🇳Mumbai, MAHARASHTRA, IndiaDr Hindavi AshtePrincipal investigator7517974943hindaviashte9624@gmail.com