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
|
|
Primary Sponsor
|
Name |
Dr Vivekanand kattimani |
Address |
SIBAR institute of dental sciences, Takkelapadu, Guntur. |
Type of Sponsor |
Other [investigator initiated ] |
|
Details of Secondary Sponsor
|
|
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
|
|
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. |