| CTRI Number |
CTRI/2021/07/034617 [Registered on: 06/07/2021] Trial Registered Prospectively |
| Last Modified On: |
05/07/2021 |
| 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
|
SIMVASTATIN EFFECTS AROUND IMMEDIATE IMPLANTS |
|
Scientific Title of Study
|
"EVALUATION OF CRESTAL BONE LEVELS USING SIMVASTATIN AS AN ADJUVANT AROUND IMMEDIATE IMPLANTS- A CLINICO-RADIOGRAPHIC STUDY". |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
HYMASREE BETHA |
| Designation |
MDS |
| Affiliation |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL,VIJAYAWADA |
| Address |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL
VIJAYAWADA
KRISHNA DISTRICT
GOVERNMENT DENTAL COLLEGE AND HOSPITAL
VIJAYAWADA
KRISHNA DISTRICT
Krishna
ANDHRA PRADESH
520004
India |
| Phone |
8688645587 |
| Fax |
|
| Email |
hymasree.betha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SONGA VAJRA MADHURI |
| Designation |
PROFESSOR |
| Affiliation |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL,VIJAYAWADA |
| Address |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL
VIJAYAWADA
KRISHNA DISTRICT
Krishna
ANDHRA PRADESH
520004
India |
| Phone |
9885333771 |
| Fax |
|
| Email |
madhuri.songa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
HYMASREE BETHA |
| Designation |
MDS |
| Affiliation |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL |
| Address |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL
VIJAYAWADA
KRISHNA DISTRICT
GOVERNMENT DENTAL COLLEGE AND HOSPITAL
VIJAYAWADA
KRISHNA DISTRICT
Krishna
ANDHRA PRADESH
520004
India |
| Phone |
8688645587 |
| Fax |
|
| Email |
hymasree.betha@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT DENTAL COLLEGE AND HOSPITAL,VIJAYAWADA |
|
|
Primary Sponsor
|
| Name |
hymasree betha |
| Address |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL,VIJAYAWADA |
| 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 |
| HYMASREE BETHA |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL |
DEPARTMENT OF PERIODONTICS
2ND FLOOR
ROOM NO 4
Krishna
ANDHRA PRADESH |
8688645587
hymasree.betha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE GOVERNMENT DENTAL COLLEGE AND HOSPITAL |
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 |
EVALUATION OF CRESTAL BONE LEVELS USING SIMVASTATIN AROUND IMMEDIATE IMPLANTS. |
local application of 2.2mg simvastatin granules on the site of implant placement
duration of therapy lasts for 3 months
|
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Age between 18-55 years
2.Good general health
3.Adequate quality and quantity of bone & Good oral hygiene status
4.Presence of non- restorable teeth due to trauma, caries, root resorption, root fracture, endodontic failure
|
|
| ExclusionCriteria |
| Details |
1.Uncontrolled diabetes measured with HbA1c levels
2.Pregnancy
3.Poor oral hygiene
4.Treatment with a bisphosphonate drug
5. Severe bruxism and clenching
Active infection or severe inflammation at proposed implant site |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| peri implant crestal bone level around immediate implants. |
BASELINE,3 MONTHS,9 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| peri implant bone volume |
cu.mm of bone volume around implant at baseline and after 9 months of placement |
|
|
Target Sample Size
|
Total Sample Size="14"
Sample Size from India="14"
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)
|
22/07/2021 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
1. The peri implant bone loss immediately after implant placement is a significant phenomenon.
2.The preservation of crestal bone is considered as a key feature for the success of the treatment given that the bone around the implant determines the stability of the soft tissue, which in turn is a crucial aspect for esthetics and long-term survival. 3.There are many proven animal studies on the positive effects and bone inducing properties of simvastatin around implants. 4.so ,the present study is planned on humans to know the effectiveness of simvastatin as an adjuvant on crestal bone levels in immediate loaded implants after extraction. |