| CTRI Number |
CTRI/2021/09/036533 [Registered on: 15/09/2021] Trial Registered Prospectively |
| Last Modified On: |
13/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of bone graft and bone graft with PRF gel in bone defects. |
|
Scientific Title of Study
|
“Comparison of Novabone putty[Alloplast] and Novabone putty with PRF gel for the treatment of infrabony periodontal defectsâ€- a split mouth study design. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M Greeshma |
| Designation |
post graduate |
| Affiliation |
Dr NTR UHS |
| Address |
Room no - 8, Department of Periodontics, St Joseph dental college,
Eluru
West Godavari
ANDHRA PRADESH
534003
India |
| Phone |
|
| Fax |
|
| Email |
dr.m.greeshma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Aravind kumar |
| Designation |
Professor |
| Affiliation |
Dr NTRUHS |
| Address |
St Joseph dental college,
Eluru
West Godavari
ANDHRA PRADESH
534003
India |
| Phone |
|
| Fax |
|
| Email |
pavuluriak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
M Greeshma |
| Designation |
post graduate |
| Affiliation |
Dr NTR UHS |
| Address |
Room no -8, Department of Periodontics, St Joseph dental college,
Eluru
West Godavari
ANDHRA PRADESH
534003
India |
| Phone |
|
| Fax |
|
| Email |
dr.m.greeshma@gmail.com |
|
|
Source of Monetary or Material Support
|
| St Joseph dental college,
Duggirala, Eluru - 534003 |
|
|
Primary Sponsor
|
| Name |
St Joseph dental college |
| Address |
St Joseph dental college,Duggirala, Eluru |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| MGreeshma |
St Joseph dental college |
Department of Periodontics,
Room No-8,
Eluru
West Godavari
ANDHRA PRADESH |
9640018720
dr.m.greeshma@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 |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOVABONE PUTTY WITH PRF GEL FOR THE TREATMENT OF INFRABONY PERIODONTAL DEFECTS |
Treatment of intra bony periodontal defects |
| Intervention |
NOVABONE PUTTYTM [ALLOPLAST] FOR THE TREATMENT OF INFRABONY PERIODONTAL DEFECTS |
Treatment of intra bony periodontal defects |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed as Chronic/ Aggressive Periodontitis with greater than 30% of the sites having attachment loss |
|
| ExclusionCriteria |
| Details |
Pregnant or lactating mothers, smokers and or alcoholics |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bone regeneration |
Baseline to six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical attachment gain |
Baseline to six months |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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 2 |
|
Date of First Enrollment (India)
|
20/09/2021 |
| 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="0"
Months="7"
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
|
The
purpose of the present study is to compare the clinical efficacy of calcium phospho silicate (NovaBone® putty) and calcium phospho silicate (NovaBone® putty) with PRF gel in treatment of
infrabony periodontal defects. |