| CTRI Number |
CTRI/2018/04/013337 [Registered on: 18/04/2018] Trial Registered Prospectively |
| Last Modified On: |
05/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of Aspirin in gum diseases |
|
Scientific Title of Study
|
Evaluation of Platelet-Rich Fibrin with and without Aspirin complex in the management of bilateral mandibular grade-II furcation defects- A Randomized 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 |
Pallavarapu Pradeepa |
| Designation |
Post Graduate Student |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Room no 5
Second Floor
Department of Periodontology
Narayana Dental College and Hospital
Chinthareddypalem
Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
8555976760 |
| Fax |
|
| Email |
pradeepabds199@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vijaykumar Chava |
| Designation |
Professor and Head |
| Affiliation |
Narayana Dental College |
| Address |
Department of Periodontology
Narayana Dental College and Hospital
Chinthareddypalem
Nellore
Narayana Dental College
Chinthareddypalem
Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9441978737 |
| Fax |
|
| Email |
chava7@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vijaykumar Chava |
| Designation |
Professor and Head |
| Affiliation |
Narayana Dental College, Chinthareddypalem, Nellore |
| Address |
Department of Periodontology
Narayana Dental College
Nellore
Narayana Dental College, Chinthareddypal
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9441978737 |
| Fax |
|
| Email |
chava7@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Dr.Pradeepa P
Postgraduate student
Department of periodontology
Narayana Dental College
Nellore |
| Type of Sponsor |
Other [Personal funding] |
|
|
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 |
| Pallavarapu Pradeepa |
Narayana Dental College Hospital |
Room No.5,
Department of Periodontology
Narayana Dental college
Chinthareddypalem, Nellore
Nellore
ANDHRA PRADESH |
8555976760
pradeepabds199@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 |
Chronic Generalised Periodontitis With Mandibular Grade-II Furcation Defects, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Open Flap Debridement with PRF, PRF Aspirin Complex |
30mg Aspirin was incorporated into 10 ml of blood to prepare PRF aspirin complex as membrane and used for local delivery in furcation defects only once. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Bilateral mandibular grade II furcation defects according to Glickman’s classification.
2.Systemic diseases known to influence the periodontal condition and not receiving any medication known to affect the status.
|
|
| ExclusionCriteria |
| Details |
1.Smokers.
2.Pregnant females.
3.Patient who are under antibiotic coverage for past 1 month.
4.Patients who had received periodontal therapy with in 6months before study are excluded.
5.Patients who are known hypersensitivity or allergy to aspirin are excluded.
6.History of alcohol abuse.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparative assessment of grade 2 furcation defect fill with PRF and PRF aspirin complex |
Baseline and six month postoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Regenerative capacity of PRF alone and PRF aspirin Complex |
Base line and six month Postoperative |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
20/04/2018 |
| Date of Study Completion (India) |
21/11/2019 |
| 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)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
No |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
A randomized clinical trial will be conducted by the Department of Periodontology, Narayana Dental College and Hospital, Nellore, Andhra Pradesh, India. A total of 30 patients with mandibular grade-II furcation defects will be selected . After full mouth scaling and root planing selected patients will be assigned to following groups. Group A: Open Flap Debridement (OFD) with PRF. Group B: Open Flap Debridement (OFD) with PRF-ASPIRIN COMPLEX. Gingival index (GI), Plaque Index (PI),Probing Depth (PD),Clinical Attachment Level and Standardized radiographic recordings will be done at baseline and 6 months. All the parameters will be subjected for statistical analysis after completion of the study to evaluate and compare the bone fill between the groups in grade-II furcation defects . Significant difference was found in both clinical and radiographic measurements in both groups.Significant radiographic bone fill was observed in PRF-A group
|