| CTRI Number |
CTRI/2023/07/055620 [Registered on: 24/07/2023] Trial Registered Prospectively |
| Last Modified On: |
18/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinico - radiographic evaluation of 1%
Alendronate gel with platelet rich fibrin in surgical
Treatment of mandibular molar grade-ii furcation defect: a
Randomized clinical trial
|
|
Scientific Title of Study
|
Clinico - radiographic evaluation of 1%
Alendronate gel with platelet rich fibrin in surgical
Treatment of mandibular molar grade-ii furcation defect: a
Randomized clinical 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 Nehal H Desai |
| Designation |
PG Student |
| Affiliation |
Government dental college and Hospital |
| Address |
Department of periodontology
1st floor
room no 112
Government dental College and Hospital jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9586975444 |
| Fax |
|
| Email |
nidhi.desai321@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayana Patel |
| Designation |
PG Guide |
| Affiliation |
Government dental college and Hospital |
| Address |
Department of periodontology
1st floor
room no 112
Government dental College and Hospital jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9586975444 |
| Fax |
|
| Email |
drnayanagpatel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nehal H Desai |
| Designation |
PG Student |
| Affiliation |
Government dental college and Hospital |
| Address |
Department of periodontology
1st floor
room no 112
Government dental College and Hospital jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9586975444 |
| Fax |
|
| Email |
nidhi.desai321@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College And Hospital Jamnagar |
|
|
Primary Sponsor
|
| Name |
Dr Nehal H Desai |
| Address |
room number 112
first floor
Department of periodontoloy
Government dental College and Hospital Jamnagar |
| Type of Sponsor |
Government medical 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 |
| Dr Nehal H Desai |
Government Dental College and hospital |
Department of periodontology
devision 6
room number 112
Jamnagar
GUJARAT |
9586975444
nidhi.desai321@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee,MP Shah Govt medical college & Guru Gobindsingh hospital, jamnagar |
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 |
| Intervention |
1% Alendronate gel and Platelet rich fibrin |
Custom made Alendronate gel and Platelet rich fibrin obtained from patient blood |
| Comparator Agent |
Platelet Rich Fibrin |
Platelet Rich Fibrin obtained from patient blood |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Grade II furcation defects in mandibular first and second molars with a radiolucent furcation
area on an intraoral periapical radiograph (IOPA)
With probing pocket depth (PPD) ≥ 5mm and probing depth horizontal (PD) ≥ 3mm after
etiotrophic phase i.e., scaling and root planing (SRP) |
|
| ExclusionCriteria |
| Details |
patient with known systemic conditions which affects the periodontal status
known medications which affect periodotal therapy outcomes
allergy to bisphophonates or history of their systemic use |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
radiograpgic outcome
Plaque index
Probing depth
Relative vertical attachment level
Relative horizontal attachment level |
preoperatively one & six months postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| radiographic evaluation with periapical radiograph |
baseline & 6 month postoperatively |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="31" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2023 |
| Date of Study Completion (India) |
01/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
Modification(s)
|
Aim & objective of this study is to evaluate clinically & radiographically; efficacy of 1% Alendronate gel in combination with PRF (prf + aln) & PRF alone in the treatment of grade ii furcation defects. 30 sample size will be included: sample will be divided into two groups (1) prf + aln (2) aln alone: after flap reflection & debridement investigational product will be placed in the furcation area & suture will be taken: clinical assessment will be done at 0,1,6 month, radiographic assessment at 0,6 month: collected data will be analysed using chi squre test |