| CTRI Number |
CTRI/2024/03/064289 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
16/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Bone material produced from egg shell is used to cover the bone defect after extraction of the tooth |
|
Scientific Title of Study
|
Egg shell derived hydroxyapatite as bone graft substitute |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prabhjot Kaur Shahi |
| Designation |
Intern |
| Affiliation |
Sri Guru Gobind Tricentary Dental College, Hospital and Research Institute, Gurgaon, Haryana, 122505 |
| Address |
Room Number 103
First Floor
Department of Oral and Maxillofacial Surgery
Sri Guru Gobind Tricentary Dental College, Hospital and Research Institute
Gurgaon
Haryana
Gurgaon
HARYANA
122505
India |
| Phone |
9560106043 |
| Fax |
|
| Email |
shahiprabhjot@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manu Gupta |
| Designation |
Professor |
| Affiliation |
Sri Guru Gobind Tricentary Dental College, Hospital and Research Institute, Gurgaon,Haryana |
| Address |
Room Number 103
First Floor
Department of Oral and Maxillofacial Surgery
Sri Guru Gobind Tricentary Dental College,Hospital and Research Institute
Gurgaon
Haryana
122505
Gurgaon
HARYANA
122505
India |
| Phone |
9991113943 |
| Fax |
|
| Email |
manu_fds@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vivekanand Kattimani |
| Designation |
Professor |
| Affiliation |
SIBAR Institute of Dental Sciences |
| Address |
Room 3
Ground Floor
Department of Oral and Maxillofacial Surgery
SIBAR Institute of Dental Sciences
Guntur
Post. Takkellpadu, Mandalam
Padakakani
Dist.Guntur
Andhra Pradesh
522509
India
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9912400988 |
| 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 |
Room 3
Ground Floor
Department of Oral and Maxillofacial Surgery
SIBAR Institute of Dental Sciences,
Guntur
Post.Takkellpadu, Mandalam
Pedakakani Dist.Guntur
Andhra Pradesh
522509 |
| Type of Sponsor |
Other [Dr Vivekanand Kattimani] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Manu Gupta |
Room Number 103
Department of Oral and Maxillofacial Surgery
Sri Guru Gobind Tricentary University
Gurgaon
Haryana
122505 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prabhjot Kaur Shahi |
Sri Guru Gobind Tricentary Dental College,Hospital and Research Institute Gurgaon, Haryana |
Room Number 103
First Floor
Department of Oral and Maxillofacial Surgery
Sri Guru Gobind Tricentary Dental College, Hospital and Research Institute
Gurgaon
Haryana
122505
Gurgaon
HARYANA |
9560106043
shahiprabhjot@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE-SGT Dental College,Hospital and Research Institute (IEC-SGTDCHRI) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients that get extraction done and have the need to fill the space that has bony deficient. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hydroxyapatite graft material
derived from natural biocompatible mineral |
Particulate graft material
derived from natural biocompatible mineral, that is, hens egg shell. As per
required quantity will be
implanted in the bone deficient areas for bone regeneration. The patients will be followed for a period of 2 months with interval at 15th day and at 60th day post intervention or grafting. It is one time intervention. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients who require grafting after extraction of the tooth to fill the bone deficient area.
2)Patients with vertical and horizontal bone loss.
3)Patients who require healthy ridge for prosthesis.
4)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
|
Other |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Healing will be faster than control group.
2) Bone height will be maintained. |
15 days, 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Bone height will be maintained.
2)Periodontally tooth will get support.
3)Ridge height will be adequate for prosthesis.
4)Aesthetic outcomes.
|
15 days, 2 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
|
Phase 4 |
|
Date of First Enrollment (India)
|
24/03/2024 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Eggshell - derived hydroxyapatite is a viable choice as a regenerative material because of its biocompatibility, faster healing, lack of disease transfer risks, ease of use, and unlimited availability of eggshell for raw material. The grafting prevented voids and undue complications with a large hematoma in the surgical defect. The Egg shell derived Hydroxyapatite acts as a space filler and osteo-conductive economic graft material. It is a versatile biocompatible graft substitute that does not cause any chronic inflammatory, allergic, or toxic reactions. |