| CTRI Number |
CTRI/2025/02/080500 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparing Patient Autologous Blood Derived Membrane And Guided Tissue Regeneration Membrane To Treat Bony Defects With Radiographic Techniques |
|
Scientific Title of Study
|
Comparison Between Use of Platelet-Rich Fibrin Membrane and Collagen Membrane Using Guided Tissue Regeneration Technique for Management of Infrabony Defects: A Clinical and Radiographic 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. Arti Odedara |
| Designation |
3rd year student |
| Affiliation |
|
| Address |
Room No. 102, Department of Periodontology and Implantology, Government Dental College and Hospital, Jamnagar
Room No. 102, Department of Periodontology and Implantology, Government Dental College and Hospital, Jamnagar, Gujarat – 361008.
Jamnagar
GUJARAT
361008
India |
| Phone |
9574958403 |
| Fax |
|
| Email |
odedraartiben@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. |
| Designation |
Head Of Department |
| Affiliation |
|
| Address |
Room No. 102, Department of Periodontology and Implantology, Government Dental College and Hospital, Jamnagar
Room No. 102, Department of Periodontology and Implantology, Government Dental College and Hospital, Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9825191911 |
| Fax |
|
| Email |
drnayanagpatel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Arti Odedara |
| Designation |
3rd year student |
| Affiliation |
|
| Address |
Room No. 102, Department of Periodontology and Implantology, Government Dental College and Hospital, Jamnagar
Room No. 102, Department of Periodontology and Implantology, Government Dental College and Hospital, Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9574958403 |
| Fax |
|
| Email |
odedraartiben@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontology Government Dental College Hospital jamnagar, Pin-361008, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Dr Arti Odedara |
| Address |
Department of Periodontology Government Dental College &
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 Arti odedara |
Government Dental College and Hospital, Jamnagar |
Room No. 102, Department of Periodontology and Implantology, Government Dental College and Hospital, Jamnagar
Jamnagar
GUJARAT |
9574958403
odedraartiben@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shree M.P. Shah Govt. Medical College and G.G. Govt. Hospital, Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K055||Other periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Guided Tissue Regenerative Membrane |
Same procedure as done for Group A will be carried out in 10 infrabony defect sites for access flap surgery in this group under local anesthesia. The defect will be managed by placing resorbable collagen membrane covering the defect. Primary closure will be obtained by 4-0 silk suture. |
| Intervention |
Platelet Rich Fibrin Membrane |
Thorough scaling and root planing will be performed with hand, rotary and ultrasonic instruments in all treated sites. Patients fulfilling the criteria for 10 infrabony defects will be appointed for surgery. Acrylic stents will be fabricated for the selected sites. These acrylic stents will made of uniform thickness with a groove placed in the line of interproximal defect, adjacent to the study tooth. This groove will be used as a fixed reference point for standardized measurements at baseline and 3 months post-operatively. Preparation of platelet-rich fibrin Before the surgical procedure, 10 mL of blood will be drawn from the subject’s antecubital site. The blood sample will be collected in glass-coated plastic tubes without adding an anticoagulant. These tubes will then immediately centrifuged for 10 min at 3000 revolutions per minute. The centrifuged blood mass presented with a structured fibrin clot in the middle of the tube, between the red corpuscle layer at the bottom and the acellular plasma on the top. The fibrin clot could easily be retrieved from the tube, shaped freely, and used immediately after its collection. PRF will be compressed between two gauze pieces to take the form. Under local anesthesia, buccal and lingual crevicular incisions will be given using a surgical blade, and mucoperiosteal flaps will be reflected. Interproximal soft tissue will be preserved as much as possible. Thorough defect debridement and root planing will be carried out with ultrasonic instruments and area-specific curettes, and the site will be irrigated. After debridement primary closure will be obtained by 4-0 silk suture. Post-surgical protocols The periodontal dressing will be given in both groups. Suitable antibiotics and analgesics will prescribed along with Chlorhexidine gluconate rinses (0.2%) twice daily for 14 days. Patients will be instructed regarding proper oral hygiene measures. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a) Probing pocket depth was more than 5mm following initial therapy.
b) Age 18- 60 years
c) Interproximal angular infrabony defects more than 3mm.
d) Acceptable oral hygiene before access flap surgery
|
|
| ExclusionCriteria |
| Details |
a) Any systemic disease which would alter the clinical outcome.
b) Habit of tobacco in any form.
c) Have no history of a previous periodontal surgery on a specified site for the last 6 months.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To gain vertical bone fill |
Baseline, 4 weeks, 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Better wound healing |
Baseline, 4 weeks, 12 weeks, 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
01/03/2025 |
| 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="1"
Months="6"
Days="3" |
|
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
|
|
The
data will be collected from the patients will be selected visiting the OPD of the
Department of Periodontology, Government Dental College and Hospital,
Jamnagar, Gujarat. After informing the patient about the study and completing
the formalities in the consent form, the patients will be enrolled and data
collection in the proforma will be done.
|
Written informed consent
will be obtained from all study participants before starting of the study.
The participants will be
randomly allocated with envelope
method into the following groups:
Group A : Open flap
debridement with placement of platelet
rich fibrin membrane
Group B : Open flap
debridement with placement of collagen membrane
|
|
|