| CTRI Number |
CTRI/2025/07/090205 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Diagnostic
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Bone Regeneration In Extracted Sockets of patients by using Eggshell-derived Nanohydroxyapatite and type 1 collagen |
|
Scientific Title of Study
|
Efficacy Of Eggshell-derived Nanohydroxyapatite Graft For Bone Regeneration In Extracted Sockets - Randomized Control 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 Poonguzhali P |
| Designation |
Post Graduate Resident |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Room No : 6 (Fisrt Floor)
Department Of Oral And Maxillofacial Surgery
Sri Ramachandra Dental College And Hospital
No. 1, Mount Poonamalle Road,
Sri Ramachandra Nagar,
Porur,
600116.
Chennai
TAMIL NADU
609001
India |
| Phone |
9629222797 |
| Fax |
|
| Email |
Pooma1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr EMMANUE DHIRAVIA SARGUNAM |
| Designation |
PROFESSOR |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Room No : 6 (First Floor)
Department Of Oral And Maxillofacial Surgery
Sri Ramachandra Dental College And Hospital
No. 1, Mount Poonamalle Road,
Sri Ramachandra Nagar,
Porur,
600116.
Chennai
TAMIL NADU
600116
India |
| Phone |
9840226274 |
| Fax |
|
| Email |
emmanuelazariah@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poonguzhali P |
| Designation |
Post Graduate Resident |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
No. 23, Sms Baby Illam,
Sengamettu Street,
Mayiladuthurai.
No. 1, Mount Poonamalle Road,
Sri Ramachandra Nagar,
Porur,
600116.
Chennai
TAMIL NADU
609001
India |
| Phone |
9629222797 |
| Fax |
|
| Email |
Pooma1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
|
|
Primary Sponsor
|
| Name |
Poonguzhali Pugazhendhi |
| Address |
No 23, Sms Baby Illam,
Sengamettu Street,
Mayiladuthurai |
| 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 |
| Poonguzhali Pugazhendhi |
Sri Ramachandra Institute Of Higher Education And Research |
Room No : 6
Department of Oral and Maxillofacial Surgery
No 1, Mount Poonamalle Road,
Sri Ramachandra Naga,r
Porur - 600116
Chennai
TAMIL NADU |
9629222797
Pooma1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee, SRIHER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K082||Atrophy of edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control |
No graft will be placed in the extraction socket |
| Intervention |
Graft |
60% Egg Shell Derived NanoHydroxyapatite with 40 % Type 1 Collagen will be placed in the extraction sockets to assess bone regeneration |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients between 20 to 60 years of age.
Patients indicated for extraction of maxillary and mandibular teeth
Patients willing for implants post placement of graft material in the socket
|
|
| ExclusionCriteria |
| Details |
Patients with absolute contraindication for extraction.
Patients with systemic disorders
Pregnant and lactating women
Patients unwilling to participate in trail
Patients allergic or sensitive to graft materials V or Type I collagen. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.To assess bone regeneration in extracted sockets using egg shell derived nano hydroxyapatite and type 1 collagen using clinical, radiographic and histologiuc assessment |
1.To assess bone regeneration in extracted sockets using egg shell derived nano hydroxyapatite and type 1 collagen using clinical, radiographic and histologiuc assessment during 1 week, 1 month , 3 months post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess bone formation in extracted sockets in patients grafted with & without egg shell derived nanohydroxyapatite
2.To assess wound healing in extracted sockets in patients grafted with & without egg shell derived nanohydroxyapatite using laundry healing index
3.To assess quality of bone formation in extracted sockets in patients grafted with egg shell derived nano hydroxyapatite during implant placement |
1.Bone formation assessed using IOPA & CBCT at 1 month & 3rd month respectively
2. wound healing assessedt using laundry healing index during 1st week, 1st month & 3rd month
3.Quality of bone formation in grafted extracted socket during implant placement after 3 months
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
23/07/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
1.Efficiency of Egg shell derived Nano hydroxyapatite will be evaluated clinically by measuring the probing depth, wound dehiscence pre operatively and post operatively. 2.Changes in bone density, bone formation characteristics, lamina dura/ surgical/socket outline, bone fill at different time intervals will be evaluated radiographically by using pre operative and post operative intraoperative periodical radiograph and CBCT. 3.Wound healing will be assess by using Landry et al (1988) 4.Histology analysis will be carried out to evaluate bone formation at the grafted site. (For patients opting for implant placement, bone biopsy shall be done from the extraction site that was initially packed with eg shell derived nanohydroxyapatite. 5.To Evaluate any surgical site infection post Extraction. |