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CTRI Number  CTRI/2017/02/007942 [Registered on: 21/02/2017] Trial Registered Prospectively
Last Modified On: 18/12/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   to check if dentin can be used as a bone graft instead of commercially available bone grafts. 
Scientific Title of Study   Evaluation of efficacy of demineralized dentin autograft , demineralized freeze dried bone allograft and hydroxyapatite, in the treatment of periodontal intraosseous defects: A comparative clinical trial 
Trial Acronym  DFDBA , HA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Divya Raj 
Designation  PG student 
Affiliation  Manipal College of Dental Sciences, Manipal 
Address  Department of Periodontology,Department no.3 Manipal College of Dental Sciences, Manipal III floor, CBS building, Tiger circle

Udupi
KARNATAKA
576104
India 
Phone  7259573377  
Fax    
Email  divyarajsinghrore@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pratibha PK 
Designation  Professor and Head 
Affiliation  Manipal College of Dental Sciences, Manipal 
Address  Department of Periodontology,Department no.3 Manipal College of Dental Sciences, Manipal

Udupi
KARNATAKA
576104
India 
Phone  7259573377  
Fax    
Email  pratibha.pk@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Divya Raj 
Designation  PG student 
Affiliation  Manipal College of Dental Sciences, Manipal 
Address  Department of Periodontology,Department no.3 Manipal College of Dental Sciences, Manipal III floor, CBS building, Tiger circle

Udupi
KARNATAKA
576104
India 
Phone  7259573377  
Fax    
Email  divyarajsinghrore@gmail.com  
 
Source of Monetary or Material Support  
Manipal College of Dental Sciences,Department no. 3, Department of Periodontology,Manipal ,Karnataka,576104 
 
Primary Sponsor  
Name  DrDivya Raj 
Address  Department of Periodontology, Department No. 3 Manipal College oof Dental Sciences, Manipal 576104 
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 Divya Raj  Manipal College of Dental Sciences  Department no 3, Maniapl college of Dental sciences, Maniapl 576104
Udupi
KARNATAKA 		 7259573377

divyarajsinghrore@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Karturba hospital Instituitional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Intraossesous Vertical Defect,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  autogenous demineralized dentin   The tooth selected for the procurement of dentin graft is extracted as atraumatically as possible. Following extraction, the root surface is made free of any calculus, soft tissue and diseased cementum using a straight carbide bur. The root portion is then made devoid of pulp tissue using number 10, 20, 30 and 40 endodontic files in a retrograde manner. The tooth is then separated into crown and root portions using a diamond separating disc. The tooth is crushed to homogenized particles using a bone crusher. The crushed granules were demineralized in 2% nitric acid (HNO3) solution (pH 1.0) for 10 minutes and rinsed in saline and then washed by Phosphate buffered saline at 7.4pH. The particulate dentin is then immersed in the basic alcohol cleanser consisting of 0.5M of NaOH and 30% alcohol (V/V) for dissolving all organic debris, bacteria and toxins .After decanting the basic alcohol cleanser, the particulate is washed twice in sterile phosphate-buffered saline. The phosphate buffer saline is decanted, washed once again with saline, leaving wet particulate dentin ready for use.  
Comparator Agent  demineralized freeze dried bone graft  obtained from Tata Tissue Bank ,Mumbai 
Comparator Agent  hydroxyapatite  commercially available as Sybograft  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Chronic generalized periodontitis
Clinical probing depth ≥ 5mm
Radiographic presence of vertical defects
Patient selected for autograft to have a tooth indicated for extraction
 
 
ExclusionCriteria 
Details  Patients with generalized aggressive periodontitis
Suffering from any systemic disease
Pregnancy or lactation
Underwent periodontal surgery previously for the same
Smokers or using other tobacco products
For patients receiving dentin as autograft:
Extracted tooth due to dental caries or periapical pathology.
Endodontically treated tooth indicated for extraction
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improved GINGIVAL INDEX – ( Loe and Silness – 1963)
• PLAQUE INDEX – (Silness and Loe – 1964)
• Pocket probing depth
• Improved Clinical attachment level 		 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Radiographic eveidence of BONE FILL
(Will be calculated using standardized IOPA Radiograph using a grid in paralleling technique) 		 6 months 
 
Target Sample Size   Total Sample Size="69"
Sample Size from India="69" 
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/03/2017 
Date of Study Completion (India) 15/10/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 ... 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Objective: The aim of the present study was to evaluate and compare the efficacy of Autogenous Demineralized Dentin (ADD) with nanocrystalline Hydroxyapatite (nHA) bone graft in intrabony periodontal defects.


Material and Methodology: Twenty-one patients with chronic periodontitis with a total of 57 intrabony defects were divided into two treatment groups. Group A (n=34) was treated with ADD, derived from a tooth indicated for extraction because of non-endodontic reasons and Group B (n=23) treated with nHA bone graft (SyboGrafâ„¢, Eurocare, India). Clinical parameters were recorded at baseline and six months and radiographic parameters recorded at baseline three months and six months.


Results: Both groups showed significant improvement of clinical and radiographic parameters from baseline to 6 months and on comparing the two groups both ADD and HA had similar treatment outcomes. Mean Probing Depth (PD) reduction from baseline to 6 months was 3.53 ± 0.95mm and 3.70 ± 1.03 mm with ADD and nHA respectively (p value = 0.764, NS), whereas the mean Probing Attachment Level (PAL) gain was 3.41 ± 1.64mm and 3.1 ±mm (p value = 0.445) respectively.  The radiographic defect fill also showed similar results (p value = 0.331) as the mean percentage 6 months post-op was 79.80% for ADD and 78.25% for nHA.


Conclusion: No adverse reaction or complication was seen in cases treated with ADD and clinically it showed comparable results with commercially available nHA. Moreover, radiographically areas of graft resorption and trabeculae formation were evident at some sites treated with ADD unlike sites treated with nHA. Therefore, ADD may be used as a bone graft substitute following histopathologic confirmation of bone formation. 
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