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CTRI Number  CTRI/2025/08/092174 [Registered on: 01/08/2025] Trial Registered Prospectively
Last Modified On: 31/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Diode laser-assisted non-surgical debridement versus open flap debridement alone. 
Scientific Title of Study   Comparative evaluation of diode laser-assisted non-surgical debridement versus open flap debridement alone. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deiji Bora 
Designation  Postgraduate Student 
Affiliation  Kothiwal Dental College and Research Centre, Moradabad. 
Address  Kothiwal Dental College and Research Centre, Mora Mustaqueem, Kanth Road, Moradabad.
Dhing, Chamuagaon, Nagaon, Assam,782123.
Moradabad
UTTAR PRADESH
244001
India 
Phone  9954176825  
Fax    
Email  itzdeijiborahere96@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Swati Agarwal 
Designation  Professor  
Affiliation  Kothiwal Dental College and Research Centre, Moradabad. 
Address  Kothiwal Dental College and Research Centre, Mora Mustaqueem, Kanth Road, Moradabad.

Moradabad
UTTAR PRADESH
244001
India 
Phone  8192917937  
Fax    
Email  swatimds86@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Swati Agarwal 
Designation  Professor 
Affiliation  Kothiwal Dental College and Research Centre, Moradabad. 
Address  Kothiwal Dental College and Research Centre, Mora Mustaqeem, Kanth Road, Moradabad.

Moradabad
UTTAR PRADESH
244001
India 
Phone  8192917937  
Fax    
Email  swatimds86@gmail.com  
 
Source of Monetary or Material Support  
Kothiwal Dental College and Research Centre, Mora Mustaqeem, Kanth Road, Moradabad, Uttar Pradesh, 244001. 
 
Primary Sponsor  
Name  Dr Deiji Bora 
Address  Kothiwal Dental College and Research Centre, Moradabad, 244001. 
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 DEIJI BORA  KOTHIWAL DENTAL COLLEGE AND RESEARCH CENTRE  KOTHIWAL DENTAL COLLEGE AND RESEARCH CENTER, MORA MUSTAQUEEM, KANTH ROAD, MORADABAD. 244001
Moradabad
UTTAR PRADESH 		 9954176825

itzdeijiborahere96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics and Review Board, Kothiwal Dental College and Research Centre, Moradabad.  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  LASER ASSISTED NONSURGICAL DEBRIDEMENT  FONA LASER power- 0.5 W, wavelength- 940nm, energy-2.5 J, frequency- 20 Hz, 320 micrometer laser tip (7mm length), duration- 60 seconds  
Comparator Agent  OPEN FLAP DEBRIDEMENT  intra-crevicular incision followed by reflection of the flap, debridement of the granulation tissues, and re-adaptation of flap with 3.0 silk suture 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1) residual probing depth 5-8 mm.
2) good level of oral hygiene after initial therapy.
3)no discrimination of gender,caste,religion or socio-economic status. 
 
ExclusionCriteria 
Details  1) medically compromised patients.
2)mentally disabled and physically handicapped patients.
3) smokers.
4) pregnant women and lactating mothers.
5) use of antibiotics in the previous 6 months.
6) uncooperative and poor oral hygiene patients 
 
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 
reduction of probing pocket depth  before intervention, after 3 months and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
plaque index,gingival index,modified sulcular bleeding index,clinical attachment level and gingival recession  before intervention, after 3 months and 6 months 
 
Target Sample Size   Total Sample Size="18"
Sample Size from India="18" 
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 2/ Phase 3 
Date of First Enrollment (India)   06/10/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [itzdeijiborahere96@gmail.com].

  6. For how long will this data be available start date provided 06-10-2025 and end date provided 06-11-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This randomized controlled, single-blind, split-mouth clinical study will compare diode laser-assisted nonsurgical debridement (Group B) with conventional open flap debridement (Group A) in 18 sites (9 per group) among patients aged 25-55 with probing depth of 5-8 mm. After Phase 1 therapy and re-evaluation,eligible patients undergo site-specific treatment. Group A receives flap reflection, debridement, suturing, and dressing. Group B receives diode laser therapy following scaling, with three cycles at set intervals.Clinical parameters PI, GI, mSBI,PPD,CAL, and GR are recorded at baseline, 3 and 6 months using standardized tools. Patients are blinded to group allocation to reduce bias, and outcomes aim to assess laser therapy as a pateint-friendly alternative. Data will be statistically analyzed,with significance set at p<0.05. 
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