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CTRI Number  CTRI/2023/05/053334 [Registered on: 31/05/2023] Trial Registered Prospectively
Last Modified On: 29/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   To compare & evaluate the outcome of surgery using laser or blade for gum disease. 
Scientific Title of Study   Comparative evaluation of clinical outcomes following either excisional new attachment procedure or diode laser assisted sulcus de-epithelization in the treatment of periodontitis- a split mouth randomized 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 Hindavi Gopal Ashte 
Designation  Post graduate student  
Affiliation  MGM Dental college and Hospital ,Kamothe,Navi mumbai 
Address  Department of Periodontics, Room no.702, 7th Floor, MGM Dental College and Hospital, at Junction of Sion Panvel Expressway, Sector 1, Kamothe, Navi Mumbai.

Raigarh
MAHARASHTRA
410209
India 
Phone  7517974943  
Fax  27423185  
Email  hindaviashte9624@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vineet Vaman Kini 
Designation  HOD and Professor in Periodontics 
Affiliation  MGM Dental college and Hospital ,Kamothe,Navi mumbai 
Address  Room no.702, 7th Floor, MGM Dental College and Hospital, at Junction of Sion Panvel Expressway, Sector 1, Kamothe, Navi Mumbai.

Raigarh
MAHARASHTRA
410209
India 
Phone  9769804390  
Fax  27423185  
Email  drvinkin@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Karishma Nitin Lodaya 
Designation  Post graduate student  
Affiliation  MGM Dental college and Hospital ,Kamothe,Navi mumbai 
Address  Room no.702, 7th Floor, MGM Dental College and Hospital, at Junction of Sion Panvel Expressway, Sector 1, Kamothe, Navi Mumbai.

Raigarh
MAHARASHTRA
410209
India 
Phone  8275009361  
Fax  27423185  
Email  karishma11lodaya@gmail.com  
 
Source of Monetary or Material Support  
MGM Dental College and Hospital Kamothe Navi Mumbai 
 
Primary Sponsor  
Name  MGM Dental College and Hospital Kamothe Navi Mumbai 
Address  Department of Periodontics Room no. 702 7th Floor MGM Dental College and Hospital Junction of NH4 and Sion-Panvel Expressway Sector 1 Kamothe Navi Mumbai 
Type of Sponsor  Other [Private Dental College and Hospital] 
 
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 Hindavi Ashte  MGM Dental College and Hospital  Department of Periodontics floor no. 7 Room no.702 Junction of NH4 and Sion-Panvel Expressway Sector 1 Kamothe Navi Mumbai
Mumbai
MAHARASHTRA 		 7517974943
27423185
hindaviashte9624@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Mahatma Gandhi Missions Dental College and Hospital Kamothe Navi Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A – Excisional new attachment procedure   clinical outcomes of probing depth reduction and clinical attachment gain following excisional new attachment procedure through use of surgical blade in treatment of periodontal pockets in chronic periodontitis after scaling and root planing at 6 weeks and 12 weeks post surgery. 
Comparator Agent  Group B – Sulcus de - epithelization.  clinical outcomes of probing depth reduction and clinical attachment gain following excisional new attachment procedure through use of diode laser in treatment of periodontal pockets in chronic periodontitis after scaling and root planing at 6 weeks and 12 weeks post surgery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details 
1.Systemically healthy patients within age group 18 yrs to 60 yrs who are willing to participate .
2. 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.
 
 
ExclusionCriteria 
Details  1. 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.
5. History of periodontal therapy in last 6 months.
6. Radiographic evidence of vertical bone loss 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
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
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  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   N/A 
Date of First Enrollment (India)   22/06/2023 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
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.

 
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