| CTRI Number |
CTRI/2025/05/086688 [Registered on: 09/05/2025] Trial Registered Prospectively |
| Last Modified On: |
06/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study comparing Titanium-platelet rich fibrin membrane with Bone graft vs Collagen Membrane with Bone Graft to manage bone loss between roots of teeth. |
|
Scientific Title of Study
|
Comparative evaluation of Titanium-platelet rich fibrin membrane and Collagen membrane along with Nanohydroxyapatite graft for the management of Grade II Furcation defects: A clinico-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 Shivani Karmalkar |
| Designation |
Post-graduate student |
| Affiliation |
SMBT Dental College and Hospital |
| Address |
G-02, Department of Periodontology, SMBT Dental College and
Hospital, Amrutnagar-Ghulewadi, Sangamner
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
9226580797 |
| Fax |
|
| Email |
karmalkars16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lisa Chacko |
| Designation |
Professor and PG Guide |
| Affiliation |
SMBT Dental College and Hospital |
| Address |
G-02, Department of Periodontology, SMBT Dental College and
Hospital, Amrutnagar-Ghulewadi, Sangamner
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
7378488875 |
| Fax |
|
| Email |
lisabrahamj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivani Karmalkar |
| Designation |
Post-graduate student |
| Affiliation |
SMBT Dental College and Hospital |
| Address |
G-02, Department of Periodontology, SMBT Dental College and
Hospital, Amrutnagar-Ghulewadi, Sangamner
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
9226580797 |
| Fax |
|
| Email |
karmalkars16@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMBT Dental College and Hospital,Amrutnagar-Ghulewadi Sangamner,
Ahmednagar, Maharashtra, India 422608 |
|
|
Primary Sponsor
|
| Name |
Dr. Shivani Karmalkar |
| Address |
G-02, Department of Periodontology, SMBT Dental College and
Hospital, Amrutnagar-Ghulewadi, Sangamner, Ahmednagar,
Maharashtra 422608 |
| 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 Shivani Karmalkar |
SMBT Dental College and Hospital |
G-02, Department of
Periodontology,
Sangamner,
Ahmadnagar
MAHARASHTRA |
9226580797
karmalkars16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Committee on Ethics, SMBT Dental College, Sangamner |
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 |
Nanocrystalline hydroxyapatite graft (Sybograf™) and Collagen membrane( Healiguide) |
In Open flap debridement Grade II Furcation defects will receive Nanocrystalline hydroxyapatite graft (Sybograf™) and Collagen membrane( Healiguide) . After packing the graft and membrane into the defect, the flaps will be repositioned to their original position and will be secured using sutures. Sutures will be removed after 7-10 days postoperatively. All clinical parameters will be re-evaluated at 3 and 6 months after surgery while radiographic bone fill will be re-assessed at 6 months postoperatively. |
| Intervention |
Nanocrystalline hydroxyapatite graft (Sybograf™) with T-PRF membrane. |
In Open flap debridement Grade II Furcation defects will receive a Nanocrystalline hydroxyapatite graft (Sybograf™) with T-PRF membrane. The T-PRF will be prepared from the patients own blood. The venous blood will be drawn into two (5mL) titanium coated tubes and centrifuged at 2800 rpm for 12 minutes. After centrifugation, the T-PRF clots will be removed from the tubes using sterile tweezers, separated from the RBC base , and placed on sterile woven gauze for 20 minutes to release the serum and compressed using PRF box to form T-PRF membrane. After packing the defects with the graft and membrane the flaps will be repositioned to their original position and will be secured using sutures. Sutures will be removed after 7-10 days postoperatively. All clinical parameters will be re-evaluated at 3 and 6 months after surgery while radiographic bone fill will be re-assessed at 6 months postoperatively. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients exhibiting atleast one Glickman’s Grade II Furcation defect with Horizontal probing depth more than or equal to 3mm, vertical probing depth more than or equal to 5mm after evaluation of phase-I therapy
2. Radiographic evidence of inter-radicular bone loss.
3. Patient willing for surgery and ready to give written consent. |
|
| ExclusionCriteria |
| Details |
1. Systemic illness known to affect the outcomes of periodontal therapy.
2. History of intake of antibiotics or other medications affecting the healing of periodontium in preceding 6 months.
3. Smokers, pregnant/lactating patients & patients with malocclusion will be excluded.
4. Platelet count less than 1,50,000/mm3
5. Patients with mobility of tooth more than or equal to Grade II.
6.Patients allergic to medications. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Full mouth Turesky Gilmore Modified Quigley Hein Plaque Index
2. Site specific Sulcus bleeding index (SBI) (Muhlemann et al 1971)
3.Site specific Probing pocket depth (PPD)
4. Relative vertical clinical attachment level (RVCAL)
5. Relative horizontal clinical attachment level (RHCAL)
6.Gingival margin level (GML)
7. Radiographic bone fill |
3 and 6 months after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
20/05/2025 |
| 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="0"
Months="9"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [karmalkars16@gmail.com].
- For how long will this data be available start date provided 15-05-2025 and end date provided 15-11-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Aim of this study is to determine if there is a difference in clinical and radiographic parameters of Grade II Furcation defects treated with open flap debridement utilizing Nanohydroxyapatite graft and Titanium platelet-rich fibrin, when compared to open flap debridement with Nanohydroxyapatite graft and Collagen membrane. After obtaining informed consent and recording a comprehensive case history, 40 sites presenting with Grade II Furcation defects were enrolled and randomly assigned into two groups: a control group treated with OFD + NcHA bone graft + Collagen membrane., and a test group treated with OFD + NcHA bone graft + T-PRF membrane. Following phase I periodontal therapy, clinical re-evaluation was conducted to confirm suitability. Defect sites were allocated using the manual lottery method, with allocation concealment and blinded assessment to minimize bias. All surgical procedures were performed by a single operator using the kirkland flap. In control group, after periodontal debridement is done, Grade II Furcation defects will receive Nanocrystalline hydroxyapatite graft (Sybograf™) and Collagen membrane( Healiguide) . After packing the graft and membrane into the defect, the flaps will be repositioned to their original position and will be secured using sutures. In test group, the Grade II Furcation defects will receive a Nanocrystalline hydroxyapatite graft (Sybograf™) with T-PRF membrane. The T-PRF will be prepared from the patient’s own blood. The venous blood will be drawn into two (5mL) titanium coated tubes and centrifuged at 2800 rpm for 12 minutes. After centrifugation, the T-PRF clots will be removed from the tubes using sterile tweezers, separated from the RBC base , and placed on sterile woven gauze for 20 minutes to release the serum and compressed using PRF box to form T-PRF membrane. After packing the defects with the graft and membrane the flaps will be repositioned to their original position and will be secured using sutures. Sutures will be removed after 7-10 days postoperatively. All clinical parameters will be re-evaluated at 3 and 6 months after surgery while radiographic bone fill will be re-assessed at 6 months postoperatively. |