| CTRI Number |
CTRI/2025/08/093259 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two types of membranes with blood concentrate to heal gum bone loss around teeth |
|
Scientific Title of Study
|
Pericardium membrane v/s collagen membrane with PRF in the treatment of 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 Sruthy Sudir |
| Designation |
Postgraduate student |
| Affiliation |
Vydehi Institute of Dental Sciences and Research Centre |
| Address |
Department of Periodontics, Room number 6,Vydehi Institute of Dental Sciences and Research Centre,82, Nallurahalli Main Rd, near BMTC 18th Depot, Whitefield, Bengaluru, Karnataka
Bangalore
KARNATAKA
560066
India |
| Phone |
9535520386 |
| Fax |
|
| Email |
SRUTHYSUDIR@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeela Guru |
| Designation |
Associate Professor |
| Affiliation |
Vydehi Institute of Dental Sciences and Research Centre |
| Address |
Department of Periodontics, Room number 6,Vydehi Institute of Dental Sciences and Research Centre,82, Nallurahalli Main Rd, near BMTC 18th Depot, Whitefield, Bengaluru, Karnataka
Bangalore
KARNATAKA
560066
India |
| Phone |
7259665551 |
| Fax |
|
| Email |
sanjeelaguru@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjeela Guru |
| Designation |
Associate Professor |
| Affiliation |
Vydehi Institute of Dental Sciences and Research Centre |
| Address |
Department of Periodontics, Room number 6,Vydehi Institute of Dental Sciences and Research Centre,82, Nallurahalli Main Rd, near BMTC 18th Depot, Whitefield, Bengaluru, Karnataka
KARNATAKA
560066
India |
| Phone |
7259665551 |
| Fax |
|
| Email |
sanjeelaguru@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sruthy Sudir |
| Address |
Department of Periodontics, Room number 6,Vydehi Institute of Dental Sciences and Research Centre,82, Nallurahalli Main Rd, near BMTC 18th Depot, Whitefield, Bengaluru, Karnataka |
| Type of Sponsor |
Other [Individual sponsor] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sruthy Sudir |
Department of Periodontics, Room number 6,Vydehi Institute of Dental Sciences and Research Centre,82, Nallurahalli Main Rd, near BMTC 18th Depot, Whitefield, Bengaluru, Karnataka |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sruthy Sudir |
Vydehi Institute of Dental Sciences and Research Centre |
Department of Periodontics, Room number 6,Vydehi Institute of Dental Sciences and Research Centre,82, Nallurahalli Main Rd, near BMTC 18th Depot, Whitefield, Bengaluru, Karnataka
Bangalore
KARNATAKA |
9535520386
SRUTHYSUDIR@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vydehi Institute of Dental Sciences Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K056||Periodontal disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Collagen membrane or Pericardium membrane |
One group treated with pericardium membrane and prf and other group treated with collagen membrane and prf in furcation defects |
| Intervention |
Treatment of furcation defects |
Two treatment options used for the resolution of furcation defects.
One group treated with pericardium membrane and prf and other group treated with collagen membrane and prf in furcation defects
Duration - 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Presence of minimum of 16 permanent teeth and more than or equal to 4 molars. Maxillary and mandibular molars with the presence Grade II furcation involvement as detected on radiography
|
|
| ExclusionCriteria |
| Details |
Patients with any systemic disease or currently under any medical treatment.
Pregnancy or lactation.
Third molars, lingual furcation sites of mandibular molars, bone loss extending to the apex.
Endodontically and non-endodontically treated teeth with periapical radiolucency, teeth with vertical fractures or cracks, mobility.
Smokers, people using other forms of smoking along with cigarettes.
Patients undergoing orthodontic treatment.
Teeth intended for extraction.
Teeth with metallic crowns.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in clinical attachment level (CAL) and probing pocket depth (PPD) at the furcation site from baseline to the endpoint (e.g., 6 or 9 months), measured clinically and confirmed radiographically. |
Change in clinical attachment level (CAL) and probing pocket depth (PPD) at the furcation site from baseline to the endpoint (e.g., 6 or 9 months), measured clinically and confirmed radiographically. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Radiographic bone fill (%) at T1/T2/T3 (standardized periapical/CBCT measurements).
Vertical and horizontal defect depth reduction (mm) on radiograph.
Furcation grade conversion (e.g., Miller/Goldman classification improvement).
Tooth mobility change (Miller index).
Gingival recession (mm) at treated sites.
Plaque Index & Gingival Index changes.
Patient-reported outcomes: post-op pain (VAS 0–10), discomfort, and satisfaction.
Wound/healing index & soft-tissue complications (dehiscence, membrane exposure, infection).
Need for re-intervention or adverse events related to procedure/materials. |
Change in clinical attachment level (CAL) and probing pocket depth (PPD) at the furcation site from baseline to the endpoint (e.g., 6 or 9 months), measured clinically and confirmed radiographically. |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 2 |
|
Date of First Enrollment (India)
|
16/09/2025 |
| 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="6"
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
|
The study will begin with a non-surgical phase, during which case history will be recorded in a standard proforma after obtaining written consent. Oral hygiene instructions will be provided, followed by scaling and root planing to control supra- and sub-gingival plaque. Clinical parameters, including plaque index (PI), gingival index (GI), probing pocket depth (PPD), clinical attachment level (CAL), and percentage of bleeding sites, along with radiographic parameters using CBCT for three-dimensional visualization and measurement of furcation defects (from cementoenamel junction to alveolar crest), will be recorded at baseline, 3 months, and 6 months after regenerative therapy. PRF will be prepared following Choukroun’s protocol by collecting 10 mL of blood without anticoagulant in a glass or glass-coated tube, immediately centrifuging at 2700 rpm for 12 minutes, and isolating the middle PRF clot between the acellular plasma layer and red corpuscle base. In the surgical phase, after routine preoperative tests, the procedure will be performed under local anesthesia (2% lignocaine with adrenaline 1:200,000). A full-thickness mucoperiosteal flap will be raised, and the furcation defect will be debrided. The defect will be filled with PRF combined with a Type I collagen membrane in Group A and PRF combined with a pericardium membrane in Group B, followed by flap suturing and standard postoperative care. |