| CTRI Number |
CTRI/2025/04/084299 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
06/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study on Bone Healing After Tooth Extraction |
|
Scientific Title of Study
|
To Assess the Bone Regeneration in extraction sockets using Simvastatin in comparison to Rosuvastatin :
a Randomized Control Trial
|
| 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 Chinmoy sanjay punalekar |
| Designation |
post graduate student |
| Affiliation |
KLE VK INSTITUTE OF DENTAL SCIENCES , KAHER , BELAGAVI, KARNATAKA - 590010 |
| Address |
OPD number 5, OMFS Department,Karnataka lingayat education society,s Vishwanath katti dental college and hospital, nehrunagar, belagavi
Belgaum
KARNATAKA
590010
India
Belgaum KARNATAKA 590010 India |
| Phone |
08605840858 |
| Fax |
|
| Email |
chinmoypunalekar460@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Vijaylaxmi Shettar |
| Designation |
Professor |
| Affiliation |
KLE VK INSTITUTE OF DENTAL SCIENCES , KAHER , BELAGAVI, KARNATAKA - 590010 |
| Address |
OPD number 5, OMFS Department,Karnataka lingayat education society,s Vishwanath katti dental college and hospital, nehrunagar, belagavi
Belgaum
KARNATAKA
590010
India
KARNATAKA
590010
India
Belgaum KARNATAKA 590010 India |
| Phone |
07349570643 |
| Fax |
|
| Email |
vijaylaxmi.s.2245@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Vijaylaxmi Shettar |
| Designation |
Professor |
| Affiliation |
KLE VK INSTITUTE OF DENTAL SCIENCES , KAHER , BELAGAVI, KARNATAKA - 590010 |
| Address |
OPD number 5, OMFS Department,Karnataka lingayat education society,s Vishwanath katti dental college and hospital, nehrunagar, belagavi
Belgaum
KARNATAKA
590010
India
Belgaum KARNATAKA 590010 India |
| Phone |
07349570643 |
| Fax |
|
| Email |
vijaylaxmi.s.2245@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karnataka lingayat education society s Vishwanath katti dental college and hospital. |
|
|
Primary Sponsor
|
| Name |
Dr. Chinmoy punalekar |
| Address |
Karnataka lingayat education society,s Vishwanath katti dental college and hospital-OPD number 5, belagavi |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Vijaylaxmi Shettar |
Karnataka lingayat education society s Vishwanath katti dental college and hospital |
OPD number 5, OMFS Department,Karnataka lingayat education society,s Vishwanath katti dental college and hospital, nehrunagar, belagavi
Belgaum
KARNATAKA
590010
India Belgaum KARNATAKA |
07349570643
vijaylaxmi.s.2245@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS AND RESEARCH COMMITTEE KLE VKIDS |
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 |
| Intervention |
Rosuvastatin 20 mg |
rosuvastatin is drug which acts on the HMG Co A reductase enzyme and leads to decrease in the cholesterol levels. it also has shown pleiotrophic activity of bone formation. |
| Comparator Agent |
Simvastatin 10 mg |
Simvastatin is drug which acts on the HMG Co A reductase enzyme and leads to decrease in the cholesterol levels. it also has shown pleiotrophic activity of bone formation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
Patients between 18 to 65 years requiring tooth extraction
Patients willing to give informed and written consent
|
|
| ExclusionCriteria |
| Details |
• Patients who are medically compromised
• Patients allergic to drug.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bone density, Bone width , Bone height measured on the cone beam computed tomography of the extracted socket |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| post operative pain using visual analog score scale. |
7 days |
|
|
Target Sample Size
|
Total Sample Size="45" Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
17/04/2025 |
| Date of Study Completion (India) |
12/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
·
Tooth loss affects the quality of
life as it leads to ineffective mastication ,altered speech, concern about the
appearance , loss of self confidence.
·
Partial or complete edentulism leads
to bone resorption making rehabilitation difficult.
·
Following tooth extraction
,Several Interventions that involve
autografts, allografts, xenografts, guided bone regeneration (GBR) and growth
factors have been used with varying degrees of success in an effort to maintain
the anatomical dimensions of the alveolus before implantation.
·
Although autograft is considered gold
standard there is risk of donor site morbidity , pain , infection , scarring ,
etc.
·
Commonly used xenograft have higher risk of the
immunological reaction and infection,
etc.
·
There is a constant search for the
ideal graft material
·
Mundy G et al (1999) examined several
compounds and found that Statin drugs like simvastatin used for lowering serum
cholesterol increased the expression of bone morphogenetic protein-2 (BMP-2)
gene in bone cells which leads to bone formation.
·
Rosuvastatin is a 2nd generation ,
hydrophilic stain which has demonstrated bone regeneration properties in
furcation defects: hence the aim of this
study is to assess efficacy of Simvastatin and Rosuvastatin in
regeneration of the bone after the extraction of the teeth. |