CTRI Number |
CTRI/2023/07/054656 [Registered on: 03/07/2023] Trial Registered Prospectively |
Last Modified On: |
10/06/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparison of vitamin C plus blood protein derivative & blood protein derivative in treatment of bone loss seen in posterior teeth |
Scientific Title of Study
|
Comparative evaluation of clinical and
radiographic effects of ascorbic acid
augmented platelet rich fibrin versus platelet
rich fibrin alone in the treatment of Grade II
furcation involvement: A randomised
controlled study. |
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 Tusharika Sharma |
Designation |
Postgraduate Student |
Affiliation |
KM SHAH DENTAL COLLEGE AND HOSPITAL |
Address |
ROOM NO 7 DEPARTMENT OF PERIODONTOLOGY
Vadodara GUJARAT 391760 India |
Phone |
8082864187 |
Fax |
|
Email |
tusharika4064@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Neeraj Deshpande |
Designation |
Professor And PG Guide |
Affiliation |
KM SHAH DENTAL COLLEGE AND HOSPITAL |
Address |
ROOM NO 7 DEPARTMENT OF PERIODONTOLOGY
Vadodara GUJARAT 391760 India |
Phone |
7600918500 |
Fax |
|
Email |
drneeraj78@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Neeraj Deshpande |
Designation |
Professor And PG Guide |
Affiliation |
KM SHAH DENTAL COLLEGE AND HOSPITAL |
Address |
ROOM NO 7 DEPARTMENT OF PERIODONTOLOGY
GUJARAT 391760 India |
Phone |
7600918500 |
Fax |
|
Email |
drneeraj78@gmail.com |
|
Source of Monetary or Material Support
|
KM SHAH DENTAL COLLEGE, SUMANDEEP VIDYAPEETH, VADODARA, GUJARAT |
|
Primary Sponsor
|
Name |
DR TUSHARIKA SHARMA |
Address |
Room No 7 Department Of Periodontology KM Shah Dental College, Vadodara, Gujarat |
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 |
Dr Tusharika Sharma |
Km Shah Dental College |
Room No 7 Department Of Periodontology Vadodara GUJARAT |
8082864187
tusharika4064@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
SUMANDEEP VIDYAPEETH INSTITUTIONAL ETHICS 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 |
Intervention |
Open flap debridement with Ascorbic Acid and Platelet rich fibrin |
In grade II furcation open flap debridement will be done with platelet rich fibrin augmented ascorbic acid and outcome will be assessed at 3 months and 6 months. |
Comparator Agent |
open flap debridement with platelet rich fibrin |
In grade II furcation open flap debridement will be done with platelet rich fibrin |
|
Inclusion Criteria
|
Age From |
25.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Age group between twenty five years to sixty years
Willing to participate in study.
Availability for follow-up appointments
Patients with mandibular molars and grade II furcation.
Clinical attachment loss more than or equal to 5 mm
Probing depth more than or equal to 6 mm
Radiographic intraosseous defect more than or equal to 3 mm
Systemically healthy |
|
ExclusionCriteria |
Details |
Pregnant or lactating mothers.
Patients with known systemic disease or blood dyscrasias or on any
medication known to interfere with outcomes of periodontal therapy.
Current smokers, tobacco chewers and alcoholic patients.
Previously treated for periodontal disease within 6 months. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Other |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Radiographic bone level,
Radiographic bone defect fill percentage |
Baseline
3 Months
6 Months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Probing Pocket Depth,
Plaque index,
Gingival Marginal Level(GML),
Clinical Attachment Level (CAL) |
Baseline
3 Months
6 Months |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
07/08/2023 |
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="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
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
|
Periodontitis is an
inflammatory destructive disorder of the periodontal supporting structures,
which is associated with microbial dysbiosis. Its primary features include the
loss of periodontal tissue support , manifested through clinical attachment
loss , presence of periodontal pocket and radiographically alveolar bone
loss. The goal of regenerative periodontal therapy, is to restore
the tooth supporting apparatus that has benn lost due to periodontal disease or
injury . PRF is classified as a second generation platelet concentrate, as it
is prepared as a natural concentrate without the addition of any
anticoagulants. Platelet rich fibrin is an easily prepared , autologous
natural scaffold harbouring a multitude of growth /differentiation
factor. Vitamin C may lower the risk of periodontal diseases and even
facilitate healing of the periodontium due to its strong
antioxidant capacity that allows it to inactivate ROS that damage
structure and function of tissues.Surgical procedure is done after presurgical
treatment ,that is scaling and root planning. After oral prophylaxis is done ,
1 week follow up is done . After 1 week clinical parameters to be evaluated and
surgery is performed in which OFD with PRF is done on one side and
on the other side OFD alongwith ascorbic acid and PRF is injected
on other side. Then flaps are approximated and then sutured . After that
clinical and radiographic parameters are evaluated at 3 months and 6 months. |