| CTRI Number |
CTRI/2022/03/041537 [Registered on: 31/03/2022] Trial Registered Prospectively |
| Last Modified On: |
13/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessment of healing after tooth removal, using graft material (sourced from eggshell) and blood derivative |
|
Scientific Title of Study
|
Socket Preservation with and without eggshell derived nanohydroxyapatite and Platelet-rich fibrin (PRF) in Mandible: A Comparative Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1275-3321 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Madhuri Shah |
| Designation |
Post-graduate Trainee |
| Affiliation |
KLE Society’s Institute of Dental Sciences |
| Address |
Department of Oral and Maxillofacial Surgery
KLE Society’s Institute of Dental Sciences
Bangalore
KARNATAKA
560022
India |
| Phone |
9864359588 |
| Fax |
|
| Email |
madhurishah95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramdas Balakrishna |
| Designation |
Professor and Head, Department of Oral and Maxillofacial Surgery |
| Affiliation |
KLE Society’s Institute of Dental Sciences |
| Address |
KLE Institutions of Dental Sciences,20, Tumkur Road, Yeshwanthpur Suburb II Stage,
Raja Industrial Estate, Yeshwanthpur
Bangalore
KARNATAKA
560022
India |
| Phone |
9845149261 |
| Fax |
|
| Email |
drramdas2007@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhuri Shah |
| Designation |
Post-graduate Trainee |
| Affiliation |
KLE Society’s Institute of Dental Sciences |
| Address |
Department of Oral and Maxillofacial Surgery
KLE Society’s Institute of Dental Sciences
Bangalore
KARNATAKA
560022
India |
| Phone |
9864359588 |
| Fax |
|
| Email |
madhurishah95@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Society’s Institute of Dental Sciences, Bangalore, Karnataka |
|
|
Primary Sponsor
|
| Name |
Dr Madhuri Shah |
| Address |
Department of Oral and Maxillofacial Surgery
KLE Society’s Institute of Dental Sciences, Bangalore, Karnataka, India 560022
|
| Type of Sponsor |
Other [SELF] |
|
|
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 Madhuri Shah |
KLE Society’s Institute of Dental Sciences |
No:3 Department Of Oral And Maxillofacial Surgery, KLE Society’s Institute of Dental Sciences, Bangalore, Karnataka, India 560022
Bangalore
KARNATAKA |
9864359588
madhurishah95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE Society’s Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
eggshell derived nanohydroxyapatite and Platelet-rich fibrin (PRF) |
eggshell derived nanohydroxyapatite one time soon after extraction along with Platelet-rich fibrin (PRF) to fill the defect and observed over a period of 6 months |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Mandibular 1st and 2nd molars indicated for extraction |
|
| ExclusionCriteria |
| Details |
Periapical pathology, cyst and/or tumours associated with those teeth
Frankly infected bony sockets
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bone regeneration, wound healing |
3rd month and 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Bone width, height and periodontal health
|
3rd month and 6th month |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/04/2022 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Socket grafting is vital to prevent bone resorption. Remodeling of alveolar bone is a continuous process in physiology and
pathology, but alveolar bone is essential for the replacement of teeth. A
systemic review of dimensional changes of the alveolar bone following
extraction showed a mean reduction of 3.8 mm in width and 1.24 mm of height in
the first six months after extraction. Replacement of missing teeth is essential, but
without the support of adequate healthy alveolar bone, teeth replacement is
difficult. Socket preservation attempts are therefore made to
maintain bone to enable patients to have implant supported prosthesis in the future
without the requirement for additional surgical procedures for augmentation. Socket preservation has been performed using different materials with
varying success rates. Materials used for grafting include autogenous
bone, allograft, xenograft, and alloplasts, among others. Various membranes have been used for wound closure, including
polytetrafluoroethylene and bovine and porcine collagen matrices. Graft materials enhance bone formation by promoting osteoconduction,
osteoinduction, and osteogenesis. However, no graft material to date is
considered ideal. Recently, nanohydroxyapatite derived from chicken eggshell
(nHA) was developed and used as an innovative graft material for bone regeneration
purposes, but only few of these previous studies have evaluated the performance
of nHA and a platelet-rich fibrin (PRF) membrane in socket preservation |