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CTRI Number  CTRI/2014/05/004578 [Registered on: 02/05/2014] Trial Registered Retrospectively
Last Modified On: 23/05/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Know the effectiveness of synthetic and bovine derived hydroxyapatite bone graft substitute in the healing of upper front tooth root area of bone.  
Scientific Title of Study   An evaluation of potential efficacy of bovine derived hydroxyapatite and synthetic hydroxyapatite crystals as osteoconductive bone graft substitute - a comparative clinical 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 Vivekanand Kattimani  
Designation  currently working as Asst Prof  
Affiliation  SIBAR institute of dental sciences  
Address  SIBAR institute of dental sciences, Takkelapadu, Guntur.
Takkelapadu, Guntur.
Guntur
ANDHRA PRADESH
522509
India 
Phone  09912400988  
Fax  08632292139  
Email  drvivekanandsk@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Srinivas P Chakravarthi  
Designation  Professor  
Affiliation  SIBAR institute of dental sciences  
Address  SIBAR institute of dental sciences, Takkelapadu, Guntur.
Takkelapadu, Guntur.
Guntur
ANDHRA PRADESH
522509
India 
Phone  09392103703  
Fax  08632292139  
Email  pscomfs@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vivekanand Kattimani  
Designation  currently working as Asst Prof  
Affiliation  SIBAR institute of dental sciences  
Address  SIBAR institute of dental sciences, Takkelapadu, Guntur.
Takkelapadu, Guntur.
Guntur
ANDHRA PRADESH
522509
India 
Phone  09912400988  
Fax  08632292139  
Email  drvivekanandsk@gmail.com  
 
Source of Monetary or Material Support  
SELF  
 
Primary Sponsor  
Name  Dr Vivekanand kattimani  
Address  SIBAR institute of dental sciences, Takkelapadu, Guntur.  
Type of Sponsor  Other [investigator initiated ] 
 
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 vivekanand kattimani   department of Oral and Maxillofacial surgery   SIBAR institute of dental sciences, takkelapadu, Guntur
Guntur
ANDHRA PRADESH 
09912400988
08632292139
drvivekanandsk@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SIBAR Institute of dental sciences, Guntur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M272||Inflammatory conditions of jaws, Patients aged between 15-45 yrs of either sex with periapical cyst or residual cyst of anterior maxilla, who required cystectomy and grafting were enrolled in the study. ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bovine derived hydroxyapatite crystals   Commercially available Bovine derived hydroxyapatite crystals acquired from market.  
Comparator Agent  synthetic hydroxyapatite crystals   Commercially available synthetic hydroxyapatite crystals acquired from market.  
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Healthy patients with periapical or residual cyst of anterior maxilla diagnosed clinically and radiologically. Who requirred cystectomy and grafting . 
 
ExclusionCriteria 
Details  Medically compromised patients.
Patients with existing metabolic diseases e.g.diabetes.
Patients with gross mobility due to moderate bone loss.  
 
Method of Generating Random Sequence   Other 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Enhancement of bone healing   8 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
No infection,
Complete bone regeneration 
3,6 months  
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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)   18/05/2009 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Awaiting for publication  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Both bovine derived and synthetic hydroxyapatite graft material are suitable for filling Bone defects, showing less resorption and enhanced bone formation with similar efficacy. However these results were obtained after short duration of follow-up and smaller sample size, but long term studies with large sample size and histomorphometry is recommended for complete evaluation of these grafts.  
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