| CTRI Number |
CTRI/2024/03/064054 [Registered on: 13/03/2024] Trial Registered Prospectively |
| Last Modified On: |
12/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate how effective is RegenerOss synthetic bone graft in healing of surgically extracted third molars when it is mixed with simvastatin gel. |
|
Scientific Title of Study
|
Comparative evaluation of Simvastatin Gel infused in commercially available bone graft in healing after surgical removal of impacted third molars – Split mouth study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Damini Goel |
| Designation |
PG. Department of Oral and Maxillofacial surgery |
| Affiliation |
Dr.DY Patil Dental College and Hospital |
| Address |
Room no.9, Dept of Oral and Maxillofacial Surgery,Dr. D Y Patil Dental College and Hospital, Dr. D Y Patil Vidyapeeth, Sant Tukaram Nagar, Pimpri, Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
7406180000 |
| Fax |
|
| Email |
dr.damini14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pushkar P Waknis |
| Designation |
MDS professor |
| Affiliation |
Dr.DY Patil Dental College and Hospital |
| Address |
Room no.9, Dept of Oral and Maxillofacial Surgery,Dr. D Y Patil Dental College and Hospital, Dr. DY Patil Vidyapeeth, Sant Tukaram Nagar, Pimpri, Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
09823047888 |
| Fax |
|
| Email |
pushkar.waknis@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pushkar P Waknis |
| Designation |
MDS professor |
| Affiliation |
Dr.DY Patil Dental College and Hospital |
| Address |
Room no.9, Dept of Oral and Maxillofacial Surgery,Dr. D Y Patil Dental College and Hospital, Dr. DY Patil Vidyapeeth, Sant Tukaram Nagar, Pimpri, Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
09823047888 |
| Fax |
|
| Email |
pushkar.waknis@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Room no.9, Department of Oral and Maxillofacial Surgery,Dr D Y Patil Dental College and Hospital D Y Patil Vidyapeeth Sant Tukaram Nagar Pune |
| SELF, 84 LOTUS ENCLAVE, PITAMPURA , DELHI-110034 |
|
|
Primary Sponsor
|
| Name |
Damini Goel |
| Address |
Room no.9, Department of Oral and Maxillofacial Surgery, Dr D Y Patil Dental College and Hospital D Y Patil Vidyapeeth Sant Tukaram Nagar Pune |
| 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 Damini Goel |
Dr DY Patil Dental College and Hospital |
Dept of Oral and maxillofacial Surgery room no.9,3rd floor,Pune
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
7406180000
dr.damini14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub Committee, Dr D.Y. Patil Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K011||Impacted teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
RegenerOss Synthetic bone graft- 1cc-calcium phosphate-based mineral combined with type I collagen derived from bovine achilles tendon infused with normal saline |
After removal of mandibular third molar, RegenerOss Synthetic bone graft infused with saline will be put into socket and sutured using suture material and will be evaluated after 3 and 6 months. |
| Intervention |
socket with 2% Simvastatin gel infused RegenerOss Synthetic bone graft- 1cc-calcium phosphate-based mineral combined with type I collagen derived from bovine achilles tendon. |
After removal of Impacted third mandibular molar, Simvastatin Gel infused RegenerOss Synthetic bone graft will be placed into the socket and sutured using suture material and will be evaluated after 3 and 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient’s age group between 18 to 35 years.
2.Patient indicated for Bilateral impacted third molar extraction with same degree of angulation.
3.Difficulty Index in between 5 and 6 according to Pederson’s scale.
4.Patient willing to undergo the surgery and participate in the study.
|
|
| ExclusionCriteria |
| Details |
1.Patients suffering from systemic diseases.
2.Any patient refusing to accept the treatment plan.
3.Patients not willing for follow up.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| soft tissue healing and bone height and width of alveolar socket post extraction will be evaluated |
after 7th day postoperatively,3 months, and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| oedema |
POD 7 |
|
|
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)
|
22/03/2024 |
| 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="1"
Months="6"
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
|
Challenges associated with the extraction of third molars, includes alveolar bone resorption and soft tissue changes. Various techniques have been employed to mitigate these issues, such as alveolar ridge preservation using biocompatible materials. Among these materials, anorganic xenografts have shown promise due to their similarity to human bone and ability to enhance bone formation.
Furthermore, statins, particularly simvastatin, have been extensively studied for their role in bone regeneration. Simvastatin has been shown to increase bone morphogenetic protein-2 (BMP-2) expression, leading to enhanced osteoblastic activity and inhibition of osteoclastic activity, ultimately promoting bone formation while also possessing anti-inflammatory properties.
The study’s goal is to evaluate the combined effect of simvastatin gel and the commercially available xenograft "RegenerOss Synthetic" on healing after the surgical removal of impacted third molars, a novel approach not previously explored in the literature. This evaluation aims to leverage the synergistic potential of simvastatin’s osteogenic and anti-inflammatory properties along with the biocompatibility and scaffold-like structure of RegenerOss Synthetic to optimize bone regeneration and soft tissue healing post-extraction. |