| CTRI Number |
CTRI/2018/05/013782 [Registered on: 09/05/2018] Trial Registered Prospectively |
| Last Modified On: |
08/05/2018 |
| 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 clinical study to evaluate the effect of drug simvastatin in treatment of jaw bone defects in between the teeth. |
|
Scientific Title of Study
|
Efficacy of locally delivered simvastain combined with autologous platelet rich fibrin in treatment of intrabony defects: A Randomized control clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
kommula mani meghana devi |
| Designation |
post graduate student |
| Affiliation |
vishnu dental college |
| Address |
Department of Periodontics,
Room no. 7,
Block no. 2,
Vishnu dental college,
Vishnupur,
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9441253717 |
| Fax |
|
| Email |
mkommula93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gautami S Penmetsa |
| Designation |
Professor |
| Affiliation |
vishnu dental college |
| Address |
Department of Periodontics,
Room no. 7,
Block no. 2,
Vishnu dental college,
Vishnupur,
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9951011618 |
| Fax |
|
| Email |
gautamipenmetsa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gautami S Penmetsa |
| Designation |
Professor |
| Affiliation |
vishnu dental college |
| Address |
Department of Periodontics,
Room no. 7,
Block no. 2,
Vishnu dental college,
Vishnupur,
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9951011618 |
| Fax |
|
| Email |
gautamipenmetsa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of periodontics,
room number 7, block II,Vishnu Dental College, Bhimavaram 534202 |
|
|
Primary Sponsor
|
| Name |
kommula mani meghana |
| Address |
vishnu dental college, vishnupur, bhimavaram-534202,west godavari district, andhra pradesh |
| Type of Sponsor |
Other [Private dental college] |
|
|
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 |
| kommula mani meghana devi |
vishnu dental college |
Department of periodontics and Implantology,Block-II,
Room number-7,
Bhimavaram-534202,
West Godavari,
Andhra Pradesh.
West Godavari
ANDHRA PRADESH |
9441253717
mkommula93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Intra-bony defects, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1.2% Simvastatin gel |
1.2% Simvastatin is mixed with methylcellulose to form gel base and combined with autologous platelet rich fibrin. |
| Comparator Agent |
Autologous Platelet rich fibrin |
10 ml of patient blood is drawn and centrifuged by choukron et al method for 10minutes to form autologous platelet rich fibrin |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age range of 20-65yrs.
2.Presence of atleast on tooth on each side of mouth with probing depth and clinical attachment level≥5mm.
3.Radiographic evidence of interproximal intra osseous defect depth≥3mm
|
|
| ExclusionCriteria |
| Details |
1.Uncontrolled periodontitis.
2.Pregnancy or lactating women.
3.Patients with any systemic disorders
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Bone fill occurring in the intrabony defects
At 3 months and 6 months.
|
Bone fill occurring in the intrabony defects
At 3 months and 6 months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Reduction in probing depth
2. Clinical attachment level gain |
1. Reduction in probing depth - 0,3,6months
2. Clinical attachment level gain - 0,3,6 months
|
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/05/2018 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized controlled clinical trial to evaluate the efficacy of 1.2%simvastatin in management of similar contra lateral intrabony defects. The primary outcome is measured in terms of amount of radiographic bone fill and reduction in the defect depth at 3 and 6 months. Secondary variables are reduction in probing pocket depth(PD), gain in clinical attachment level(CAL), gingival recession(GR) recorded at 3 months and 6 months. |