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CTRI Number  CTRI/2025/05/087440 [Registered on: 22/05/2025] Trial Registered Prospectively
Last Modified On: 02/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluating the Impact of Diode Laser Therapy Combined with Modified Widman Flap Surgery: A Split-Mouth Study 
Scientific Title of Study   Assessment of diode laser effectiveness as an adjunct to modified widman flap surgery – a split-mouth study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gorremutchu Sarath Swaroop 
Designation  Pg student 
Affiliation  SIBAR INSTITUTE OF DENTAL SCIENCES 
Address  Room no 8 department of periodontology Sibar institute of dental sciences Takellapadu guntur Guntur ANDHRA PRADESH 522509 India Guntur ANDHRA PRADESH 522509 India

Guntur
ANDHRA PRADESH
522509
India 
Phone  9502992296  
Fax    
Email  sarathswaroop300@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  K Lakshmikanth 
Designation  Professor 
Affiliation  SIBAR INSTITUTE OF DENTAL SCIENCES 
Address  Room no 8 department of periodontology Sibar institute of dental sciences Takellapadu guntur Guntur ANDHRA PRADESH 522509 India Guntur ANDHRA PRADESH 522509 India

Guntur
ANDHRA PRADESH
522509
India 
Phone  9441081047  
Fax    
Email  drkanth99@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  K Lakshmikanth 
Designation  Professor 
Affiliation  Sibar institute of dental sciences 
Address  Room no 8 department of periodontology Sibar institute of dental sciences Takellapadu guntur Guntur ANDHRA PRADESH 522509 India Guntur ANDHRA PRADESH 522509 India

Guntur
ANDHRA PRADESH
522509
India 
Phone  9441081047  
Fax    
Email  drkanth99@yahoo.co.in  
 
Source of Monetary or Material Support  
Sibar institute of dental sciences takellapdu guntur Andhrapradesh India 522509 
 
Primary Sponsor  
Name  Gorremutchu Sarath Swaroop 
Address  Room no 8 department of periodontology Sibar institute of dental sciences Takellapadu guntur Guntur ANDHRA PRADESH 522509 India Guntur ANDHRA PRADESH 522509 India 
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 K Lakshmikanth  Sibar institute of dental sciences  Room no 8 Department of periodontology Sibar institute of dental sciences takkellapadu Guntur Andhrapradesh India 522509
Guntur
ANDHRA PRADESH 		 9441081047

drkanth99@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sibar institute of dental sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  chronic periodontitis 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  laser debridement as an adjunct to modified widman flap surgery  a 980nm diode laser is used for debridement 
Comparator Agent  periodontal flap surgery alone  modified widman periodontal flap surgery alone is performed in control group 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Age group 35-55 years
2. Apparently healthy subjects
3. Stage 3 periodontitis (Interdental CAL loss greater than or equal to 5mm, radiographic bone loss extending to mid-third of root and beyond, tooth loss due to periodontitis of less than or equal to 4 teeth, Pocket depth of greater than or equal to 6mm).
 
 
ExclusionCriteria 
Details  1. H/o antibiotics intake in last 3months.
2. Periodontal treatment in last 6 months.
3. Pregnant (or) lactating women.
4. Any form of tobacco usage.
5. Presence of any intra bony defects, and
teeth with grade 2 or 3 mobility.
6. Patients who are deemed to be
uncooperative.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.To assess Pocket depth, Clinical attachment level, Gingival Recession, Gingival bleeding index, Microbial analysis (PCR) and wound healing with laser following Modified Widman flap.
2.To assess Pocket depth, Clinical attachment level, Gingival Recession, Gingival bleeding index, Microbial analysis (PCR) and wound healing without laser following Modified Widman flap. 		 baseline and 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare Pocket depth, Clinical attachment level, Gingival Recession, Gingival bleeding index, Microbial analysis (PCR) and wound healing with and without laser following modified Widman flap.  baseline and 3 months 
 
Target Sample Size   Total Sample Size="16"
Sample Size from India="16" 
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 3 
Date of First Enrollment (India)   17/06/2025 
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="1"
Months="6"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The present study is a split mouth study design. A total of 16 Stage 3 Periodontitis patients will be selected into the study. Out of it the sample is equally divided into two groups based on inclusion and exclusion criteria.

 Group A  Modified Widman flap surgery with laser application

 Group B  Modified Widman flap surgery alone

At the initial visit, clinical examination will be performed on each patient and those who are diagnosed as stage 3 periodontitis, are indicated for surgery will be included in the study. All patients will receive phase I therapy which includes scaling, root planing and thorough oral hygiene instructions will be given. Two weeks after scaling, baseline clinical parameters will be recorded and subgingival plaque samples will be collected using sterile curette, the collected samples will be transferred for microbiologic analysis.
Patients who had atleast 2 quadrants with minimum  of 3 teeth each having a probing depth of greater than or equal to 6mm indicated for the surgery will be selected and quadrants will be  randomly allocated to group A or Group B by a flip of coin method.   


 

 
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