| CTRI Number |
CTRI/2014/12/005340 [Registered on: 31/12/2014] Trial Registered Prospectively |
| Last Modified On: |
30/04/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
To check healing using bone material produced from egg shell |
|
Scientific Title of Study
|
AN EVALUATION OF EGG SHELL DERIVED HYDROXYAPATITE AS BONE GRAFT MATERIAL IN THE HEALING OF BONE DEFECTS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1163-5922 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vivekanand Kattimani |
| Designation |
Asst Prof |
| Affiliation |
Department of Oral and Maxillofacial surgery, |
| Address |
SIBAR Institute of dental Sciences
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9912400988 |
| Fax |
|
| Email |
drvivekanandsk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr L Krishna Prasad |
| Designation |
Prof and HOD |
| Affiliation |
Department of Oral and Maxillofacial surgery, |
| Address |
SIBAR Institute of dental Sciences
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
|
| Fax |
|
| Email |
dr_lkp@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vivekanand Kattimani |
| Designation |
Asst Prof |
| Affiliation |
Department of Oral and Maxillofacial surgery, |
| Address |
Department of Oral and Maxillofacial surgery,
SIBAR Institute of dental Sciences
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
09912400988 |
| Fax |
|
| Email |
drvivekanandsk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Oral and Maxillofacial suregry, SIBAR institute of dental sciences, Guntur |
|
|
Primary Sponsor
|
| Name |
Dr Vivekanand Kattimani |
| Address |
Dr Vivekanand Kattimani,
Department Oral and Maxillofacial suregry, SIBAR institute of dental sciences, Guntur |
| Type of Sponsor |
Other [Dr Vivekanand Kattimani] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr L Krishna Prasad |
Professor and HOD,
Department Oral and Maxillofacial suregry, SIBAR institute of dental sciences, Guntur |
|
|
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 |
Departament of Oral and Maxillofacial surgery |
SIBAR Institute of dental Sciences
Guntur
ANDHRA PRADESH |
09912400988
drvivekanandsk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
1) Extraction of decayed tooth 2) surgical removal of impacted tooth Extraction for orthodontic and prosthodontic purpose 3) Any tooth indicated for extraction either using closed or open method of extraction requiring socket preservation or grafting |
| Patients |
1. undergoing cystectomy
2.undergoing surgical removal of impacted third molar
3.patients with periodontal bone defects
4. Requiring bone grafting for bone regeneration after ablative surgery , (1) ICD-10 Condition: M275||Periradicular pathology associatedwith previous endodontic treatment, (2) ICD-10 Condition: M278||Other specified diseases of jaws, (3) ICD-10 Condition: D164||Benign neoplasm of bones of skulland face, (4) ICD-10 Condition: M897||Major osseous defect, (5) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
The patients who are not receiving the graft material and are considered as control groups |
| Intervention |
Hydroxyapatite graft material derived from natural bio mineral |
Particulate graft material derived from natural bio mineral hens egg shell waste.
As per required quantity will be implanted in the defects for bone regeneration. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients who require grafting after cystic removal, tumor surgery, periodontal bone defects.
2)Willing to participate in study and followup visits
|
|
| ExclusionCriteria |
| Details |
1) Pregnant patients
2) Medically compromised patients
3) Metabolic diseases affecting bone regeneration- Diabetics, Thyroid.
4)Not willing for regular followup visits |
|
Method of Generating Random Sequence
Modification(s)
|
Other |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1)Healing will be faster than control group |
1,3,6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) In surgical removal no pocket formation
2)Bone height will be maintained
3)Periodontally tooth will get support
4)the aesthetics, function will improve with structural balance to orofacial structure |
1,3,6 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/01/2015 |
| 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="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
1) Natural bioceramics: our experience with changing perspectives in the reconstruction of maxillofacial skeleton. J Korean Assoc Oral Maxillofac Surg. 2019;45(1):34–42.
2) Eggshell-Derived Hydroxyapatite: A New Era in Bone Regeneration. J Craniofac Surg. 2016 Jan;27(1):112-7. doi: 10.1097/SCS.0000000000002288. PubMed PMID:
26674907. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Eggshell-derived hydroxyapatite becomes a viable choice as regenerative material because of its biocompatibility, lack of disease transfer risks, ease of use, and unlimited availability of eggshell raw material. The grafting prevented dead space and undue complications associated with a large hematoma in the surgical defect. The EHA acts as a space filler and osteoconductive economic graft material. It is a versatile biocompatible graft substitute that does not cause any chronic inflammatory, allergic, or toxic reactions.
|