| CTRI Number |
CTRI/2024/03/063965 [Registered on: 11/03/2024] Trial Registered Prospectively |
| Last Modified On: |
25/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of the Alveolar Ridge Dimensions Following Simple Extraction of Maxillary and Mandibular Molars With and Without the Use of Local Simvastatin in Post-Extraction Socket: A Randomized Clinical Study. |
|
Scientific Title of Study
|
Comparative Evaluation of the Alveolar Ridge Preservation Following Intra Alveolar Extraction of Maxillary and Mandibular Molars With and Without the Use of Local Simvastatin: A Randomized Clinical 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 CHARLOTTE SALDANHA |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
MGM DENTAL COLLEGE AND HOSPITAL, KAMOTHE |
| Address |
Department of Oral and Maxillofacial Surgery, MGM Dental College and Hospital, Junction of NH4 and Sion-Panvel Expressway, Sector 1, Kamothe, Navi Mumbai.
Raigarh
MAHARASHTRA
410209
India |
| Phone |
9821461878 |
| Fax |
|
| Email |
charlottesaldanha5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR USHA ASNANI |
| Designation |
PROFESSOR |
| Affiliation |
MGM DENTAL COLLEGE AND HOSPITAL, KAMOTHE |
| Address |
Department of Oral and Maxillofacial Surgery, MGM Dental College and Hospital, Junction of NH4 and Sion-Panvel Expressway, Sector 1, Kamothe, Navi Mumbai.
Raigarh
MAHARASHTRA
410 209
India |
| Phone |
9820897181 |
| Fax |
|
| Email |
drushaasnani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR CHARLOTTE SALDANHA |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
MGM DENTAL COLLEGE AND HOSPITAL, KAMOTHE |
| Address |
Department of Oral and Maxillofacial Surgery, MGM Dental College and Hospital, Junction of NH4 and Sion-Panvel Expressway, Sector 1, Kamothe, Navi Mumbai.
Raigarh
MAHARASHTRA
410 209
India |
| Phone |
9821461878 |
| Fax |
|
| Email |
charlottesaldanha5@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Dental College and Hospital, Junction of NH4 and Sion-Panvel Expressway, Sector 1,
Kamothe, Navi Mumbai. Pin 410209. |
|
|
Primary Sponsor
|
| Name |
DR CHARLOTTE SALDANHA |
| Address |
B- 207, Radha Krishan CHS, Plot No 2A, Sector 42A, Seawoods, NAVI MUMBAI- 400706 |
| 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 Charlotte Saldanha |
MGM Dental College and Hospital |
Department of Oral and
Maxillofacial Surgery, 4th floor
Raigarh
MAHARASHTRA |
9821461878
charlottesaldanha5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE MGM DENTAL COLLEGE & HOSPITAL KAMOTHE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
10mg Simvastatin |
Topical Simvastatin is packed in the socket along with absorbable gelatin sponge for 3 months |
| Comparator Agent |
Absorbable gelatin sponge |
Only absorbable gelatin sponge is packed in the socket |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients indicated for maxillary and mandibular molar intra alveolar extraction under local anaesthesia.
2. Tooth with adjacent teeth present and intact.
3. Tooth indicated for extraction without any
radiographically evident periapical lesion.
4. Patients willing to be a part of the study. |
|
| ExclusionCriteria |
| Details |
1. Teeth which require transalveolar method of
extraction under local anaesthesia.
2. Patients indicated for maxillary and mandibular third molar extractions.
3. Patients with uncontrolled periodontal diseases.
4. Patients with known allergy to statins.
5. Patients with systemic comorbidities that are contraindications for extraction and affect bone metabolism and healing.
6. Patients on steroid therapy.
7. Patients undergoing radiotherapy.
8. Smokers and Alcoholics.
9. Pregnancy based on history. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare efficacy of locally applied
simvastatin in alveolar ridge preservation in post extraction sockets of maxillary and mandibular molars. |
Immediate post extraction, at 8 weeks, at 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare bone density following intra
alveolar extraction of maxillary and mandibular molars with and without the use of local simvastatin. |
Immediate post extraction, at 8 weeks, at 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
31/03/2024 |
| 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="9"
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
|
Statins are specific inhibitors of 3-hydroxy-3methylglutaryl coenzyme A (HMG-CoA) reductase which is involved in the conversion of HMG-CoA to mevalonate, thus reducing the hepatic synthesis of cholesterol. Simvastatin is a chemically modified statin that stimulates bone formation by increasing the gene expression of bone morphogenetic protein-2 (BMP 2) and vascular endothelial growth factor (VEGF). The time of extraction is the best time to preserve the alveolar ridge. Ridge preservation can prevent 40%–60% of the jaw bone atrophy that normally happens 2–3 years after tooth extraction. Simvastatin can be topically or systemically administered to take advantage of its anabolic effects on bone. Systemically administered simvastatin has less than 5% bioavailability due to high first pass metabolism in the liver. Hence local drug delivery systems are used to directly deliver simvastatin to the site of action. The existing methods of ridge preservation include the use of autogenous, allogenic, xenogenous grafts, and alloplasts. Autogenous bone offers osteoinduction, osteogenicity and an osteoconductive matrix that are necessary for bone repair. But disadvantages like, a second surgical site, donor site morbidity, stability of graft, storage, post-operative discomfort and increased surgical time subsequently led to the development of various alternatives like pharmacologic compounds such as simvastatin that can upregulate the necessary autogenous growth factors and will be a cost-effective way to correct bone defects. Simvastatin packed locally in extraction sockets is safe, painless, inexpensive with no side effects and improved tissue repair. This study is designed prospectively to radiographically assess the alveolar ridge preservation following intra alveolar extraction of maxillary and mandibular molars with and without the use of local simvastatin by evaluating changes in bone density, ridge width and ridge height by comparing with sockets packed with local simvastatin. The rationale of the study is to evaluate the role of simvastatin in post extraction sockets for ridge preservation. |