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CTRI Number  CTRI/2023/11/059834 [Registered on: 14/11/2023] Trial Registered Prospectively
Last Modified On: 25/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical and radiographic trial to study the treatment outcomes for bony defects using autograft VS combination of demineralized bone matrix and autograft. 
Scientific Title of Study   Comparative evaluation of the treatment outcomes for intrabony vertical defects by intra oral osseous autograft vs demineralized bone matrix and intra oral free osseous autograft- a clinical and radiographic evaluation. 
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sakshi Kanherkar  
Designation  Post Graduate student  
Affiliation  SMBT Dental College and Hospital  
Address  G 02, Department of Periodontics, SMBT Dental and Hospital
Ghulewadi, Sangamner
Ahmadnagar
MAHARASHTRA
422608
India 
Phone  9870531997  
Fax    
Email  sakshik0305@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Purushottam Rakhewar  
Designation  HOD, Proffesor and Guide  
Affiliation  SMBT Dental College And Hospital 
Address  G 02, Department of Periodontics, SMBT Dental and Hospital
Ghulewadi, Sangamner
Ahmadnagar
MAHARASHTRA
422608
India 
Phone  939370017343  
Fax    
Email  drpsrakhewar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sakshi Kanherkar  
Designation  Post Graduate Student 
Affiliation  SMBT Dental College and Hospital  
Address  G 02, Department of Periodontics, SMBT Dental and Hospital
Ghulewadi, Sangamner
Ahmadnagar
MAHARASHTRA
422608
India 
Phone  9870531997  
Fax    
Email  sakshik0305@gmail.com  
 
Source of Monetary or Material Support  
G 02, Department of Periodontics, SMBT Dental and Hospital, Ghulewad, Sangamner 
 
Primary Sponsor  
Name  NONE 
Address  NONE 
Type of Sponsor  Other [NONE] 
 
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 Sakshi Kanherkar  SMBT Dental college and hospital  G-02, Department of periodontics
Ahmadnagar
MAHARASHTRA 
9870531997

sakshik0305@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
COMMITTEE ON ETHICS SMBT DENTAL COLLEGE SANGAMNER  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  Autograft  Autograft from intra oral sites will be procured for treatment of intrabony vertical defects and follow up will be done at 3 months and 6 months 
Comparator Agent  Combination of Demineralized Bone matrix and autograft  Both demineralized bone matrix and autograft in combination will be placed in the vertical defect and follow up will be done at 3 months and 6 months  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.PRESENCE OF PERIODONTITIS WITH VERTICAL INTRABONY DEFECT HAVING PROBING POCKET DEPTH PPD MORE THAN OR EQUAL TO 5 MM, RADIOGRAPHIC DEFECT DEPTH MORE THAN OR EQUALTO 3MM AFTER PHASE I THERAPY.
2.ABSENCE OF ANY ANATOMICAL LIMITATIONS.
3.PATIENT WILLING TO UNDERGO SURGERY AND READY TO GIVE WRITTEN CONSENT.
 
 
ExclusionCriteria 
Details  1) Patients with systemic diseases, smokers and pregnant and lactating women.
2) Individuals with unacceptable oral hygiene.
3) Patients contraindicated for periodontal surgery.
4) Patients undergone periodontal therapy for past 6 months.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
COMPARE REDUCTION IN PROBING DEPTH FOR INTRABONY VERTICAL DEFECTS   Baseline to 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
NONE  NONE 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 4 
Date of First Enrollment (India)   01/01/2024 
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="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    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 [sakshik0305@gmail.com].

  6. For how long will this data be available start date provided 01-08-2024 and end date provided 01-10-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Aim of the study is to compare the treatment outcomes for intrabony vertical defects using autogenous bone graft alone and combination of demineralized bone matrix and autogenous bone graft. All participants will be explained about the need and design of the study. Informed consent will be obtained from the patients. Through clinical case history will be recorded. Each patient will undergo ultrasonic scaling (EMS) by a single operator. All clinical parameters (GI, PI, PPD, CAL, BOP) will be recorded using UNC15 periodontal probe (Hu Friedy )  at baseline, 3 months and 6 months interval. It is a single blind study in which the patient will be randomly assigned to either autogenous bone graft group (control) or combination of demineralized bone matrix and autogenous bone graft group (test) using manual lottery method. After allotment of the groups following surgical method will be performed. . Intraoral antisepsis will be performed with 10ml of 0.2% chlorhexidine digluconate rinse and by a povidine iodine solution extra oral antisepsis will be carried out. The site scheduled for surgery will be anesthetized by appropriate local anesthesia.  After administration of local anesthesia, incisions  will be made intracrevicularly  through the bottom of the pocket on both facial and the lingual/palatal as well as interdental  area. Incision will be performed from distal to mesial aspect of the area planned for the surgery. Mucoperiosteal flaps will be elevated beyond the mucogingival junction in order to achieve primary closure in all cases irrespective of groups. The marginal bone and diseased root surfaces will be exposed. Care will be taken to preserve as much interproximal soft tissue as possible. Meticulous defect debridement and root planning will be carried out using hand instruments and area-specific curettes in order to remove calculus, necrotic cementum and granulation tissues. No osseous recontouring will be performed, similar procedure will be performed for both control site and the test site. Control site will be treated with autogenous bone graft alone and test site will be treated with autogenous bone graft and demineralized bone matrix. The piezo electric device will be used for bone removal for autogenous bone grafting. It will placed directly into the recipient site. Autogenous bone graft of the required size will be procured by extending the mucoperiosteal flap in the adjacent tooth area to cover the osseous defect in the control group.  Combination of ABG + DMM will be used to cover the osseous defect in the test group. Mucoperiosteal flaps will be repositioned and secured in place using non-absorbable black silk suture. The interrupted sutures will be placed. The surgical area will be protected and covered with periodontal dressing. The following post operative care will be given to the patients Sutures will be removed after 7-10 days postoperatively.  Antibiotics & Analgesics will be prescribed. Each patient will be instructed for proper oral hygiene measure at each appointment. Patients will be instructed to avoid using toothbrush at the surgical site. Teeth cleaning will be initiated with gentle brushing using soft brush after suture removal. All clinical parameters will be re-evaluated 3 months and 6 months after surgery by second blinded operator. Radiographic parameters will be re-evaluated 6 months after surgery. 

 
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