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A Comparative evaluation of Platelet Rich Fibrin Matrix (PRFM) AND Coronally Advanced Flap(CAF) with and without Peripheral Blood Mesenchymal Stem Cells (PBMSCs) in the surgical management of Gingival Recession Type 1 – A Split-mouth Randomised Controlled Trial.

A Comparative evaluation of Platelet Rich Fibrin Matrix (PRFM) AND Coronally Advanced Flap(CAF) with and without Peripheral Blood Mesenchymal Stem Cells (PBMSCs) in the surgical management of Gingival Recession Type 1 – A Split-mouth Randomised Controlled Trial.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/02/062289
Enrollment
34
Registered
2024-02-05
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K060- Gingival recession

Interventions

Intervention1: PBMSCs and PRFM (Supercell): During the mucogingival surgical procedure, lasting for about 2 hours
Following optimum anaesthesia and reflection of a mucoperiosteal flap, thorough debridement will be done. Subsequently, the defect will be filled with PBMSCs and PRFM (Supercell) in the test sites. Co
Following optimum anaesthesia and reflection of a mucoperiosteal flap, thorough debridement will be done. Subsequently, the defect will be filled with PRFM in the control sites.

Sponsors

DR JEEVIKA A DAS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Systemically healthy male and female subjects in the age group of 20-50 years, with gingival recession type 1 defect on at least 2 adjacent teeth, with no radiographic evidence of interdental bone loss. Probing pocket depth = 3 mm. Adequate width of attached gingiva.

Exclusion criteria

Exclusion criteria: Pregnant/lactating women. Patients on drug therapy known to affect the number and function of platelets in the past 3 months. Patients with abnormal platelet count or having disease affecting platelet count. Patients with immunologic diseases. Current and former smokers. Patients having a history of periodontal therapy in the last 6 months. Any other contraindications for periodontal surgery.

Design outcomes

Primary

MeasureTime frame
1. Plaque Index (PI): Silness and Loe (1964) 2. Gingival Index (GI): Loe and Silness (1963) 3. Vertical Component Of The Gingival Recession (VGR) 4. Horizontal Component Of The Gingival Recession (HGR) 5. Probing Pocket Depth (PPD) 6. Clinical Attachment Level (CAL) 7. Width of Attached Gingiva (WAG) 8. Width of Keratinized Gingiva (KG) 9. Gingival Thickness (GT) Timepoint: Baseline, 3 months, 6 months, 1 year, and 2 year.—

Secondary

MeasureTime frame
Root Coverage Esthetic Score (RCES): Cairo et. al. (2009)Timepoint: 6 months, 1 year, 2 year.—

Countries

India

Contacts

Public ContactDR JEEVIKA A DAS

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

doc_sphoo@yahoo.com9916010380

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026