| CTRI Number |
CTRI/2014/09/004947 [Registered on: 01/09/2014] Trial Registered Retrospectively |
| Last Modified On: |
28/10/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To know the effectiveness of different origin bone graft material in earlier formation of bone in bone defects after removal of disease. |
|
Scientific Title of Study
|
An evaluation of egg shell derived hydroxyapatite as bone graft substitute in the healing of maxillary cystic bone defects - a clinical study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1156-2850 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vivekanand Kattimani |
| Designation |
Asst Prof |
| Affiliation |
SIBAR institute of dental sciences |
| Address |
SIBAR institute of dental sciences, Takkelapadu, Guntur. Andhra Pradesh. India. .
Takkelapadu, Guntur.
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
09912400988 |
| Fax |
08632292139 |
| Email |
drvivekanandsk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivekanand Kattimani |
| Designation |
Asst Prof |
| Affiliation |
SIBAR institute of dental sciences |
| Address |
SIBAR institute of dental sciences, Takkelapadu, Guntur. Andhra Pradesh. India. .
Takkelapadu, Guntur.
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
09912400988 |
| Fax |
08632292139 |
| Email |
drvivekanandsk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vivekanand Kattimani |
| Designation |
Asst Prof |
| Affiliation |
SIBAR institute of dental sciences |
| Address |
SIBAR institute of dental sciences, Takkelapadu, Guntur. Andhra Pradesh. India. .
Takkelapadu, Guntur.
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
09912400988 |
| Fax |
08632292139 |
| Email |
drvivekanandsk@gmail.com |
|
|
Source of Monetary or Material Support
|
| SIBAR institute of dental sciences, Guntur, Andhra Pradesh. India. |
|
|
Primary Sponsor
|
| Name |
DrVivekanand Kattimani |
| Address |
Asst Prof,
SIBAR institute of Dental Sciences,Takkelapadu, Guntur |
| Type of Sponsor |
Other [investigator initiated ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Prof Dr Sampat Kumar |
Head of Department.
Department of metallurgical and materials engineering, IITM, Chennai. 6000036 |
|
|
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
|
| Health Type |
Condition |
| Patients |
Patients who requires bone grafting after cystectomy or apicoectony ., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Egg shell derived hydroxyapatite |
The hydroxyapatite crystals will be grafted in cystic bone defects depending on size of lesion. example- average 2X2 cm lesions require 10 cc of graft material. The graft will be filled in bony defects under periosteum and in bone.once after cystic enucleation. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients with periapical cyst diagnosed clinically and radiologically,who required cystectomy and grafting . |
|
| ExclusionCriteria |
| Details |
Medically compromised patients.
Patients with metabolic diseases e.g.diabetes.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Enhanced bone healing |
4-8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Good bone density, early bone formation, less pain. No infection |
4-8 weeks |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
02/03/2009 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
Eggshell Derived Hydroxyapatite as Bone Graft Substitute in the Healing of Maxillary Cystic
Bone Defects: A Preliminary Report- Journal of International Oral Health 2014; 6(3):15-19 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Egg shell derived hydroxyapatite showed biocompatibility , better bone healing compared to bovine derived hydroxyapatite. Raw material for Egg shell derived hydroxyapatite is available in unlimited quantity. It can be easily sterilized by autoclaving without altering its biological properties. It’s economical and showed good bone regeneration efficacy in rats and surface modified egg shell material in human maxillary defects. . |