Evaluation of The Effect of Injectable Platelet-rich Fibrin With Collagen Membrane in Miller Class II Gingival Recession Coverage

NCT07717398 | Completed

• 1 other identifier: I_PRF with collagen membrane
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effect of injectable Platelet-Rich Fibrin (i-PRF) in combination with collagen membrane in the treatment of Miller Class II gingival recession. Gingival recession is a common periodontal condition characterized by apical displacement of the gingival margin, which may lead to aesthetic concerns, root hypersensitivity, and increased risk of root caries. The study will include patients diagnosed with Miller Class II gingival recession. Participants will be treated using a regenerative periodontal surgical approach involving coronally advanced flap combined with injectable platelet-rich fibrin and collagen membrane. Clinical parameters such as recession depth, clinical attachment level, and keratinized tissue width will be evaluated before and after treatment at specific follow-up intervals. The objective is to compare the effectiveness of this combined regenerative approach in improving root coverage and soft tissue healing, and to assess its potential benefits in periodontal regeneration and esthetic outcomes.

Conditions

Gingival Recession (Miller II)

Outcome Measures

Primary Outcomes (1)

• Keratinized Tissue Thickness

  measured in millimeters (mm) using a endodontic file

  Baseline, 1 month ,3 months and 6 months after surgery

Secondary Outcomes (4)

• Recession Depth (RD)

  baseline,1 month,3 months,6 months after surgery

• Recession Width (RW)

  Baseline,1 month,3 months ,and 6 months after surgery

• keratinized Tissue Height (KTH)

  Baseline, 1 month, 3 months, 6 months after surgery

• Probing Pocket Depth (PPD)

  Baseline and 6 months after surgery

Study Arms (2)

Group 1

EXPERIMENTAL

i-PRF +collagen membrane

Procedure: Group (1)

Group 2

ACTIVE COMPARATOR

CAF+SCTG

Procedure: Group 2

Interventions

Group (1) PROCEDURE

Application of injectable platelet -rich fibrin (I-PRF) in combination with a collagen membrane during the surgical procedure to enhance soft and hard tissue healing

Also known as: I-PRF+collagen membrane

Group 1

Group 2 PROCEDURE

coronally advanced flap surgery combined with a subepithelial connective tissue graft for the treatment of gingival recession defects

Also known as: CAF+ SCTG

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both males and females of age ≥ 18

You may not qualify if:

• History of systemic diseases (i.e. diabetes, autoimmune dysfunction, prolonged cortisone therapy, or chemotherapy) that contraindicated periodontal surgical treatment.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of dentistry ,Tanta university

Tanta, Gharbia Governorate, Egypt

Location

MeSH Terms

Conditions

Gingival Recession

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Shereen Abdelmoula Ali

  Faculty of dentistry ,Tanta university .Tanta, Eygpt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaaching Assistant, Faculty of Dentistry,Tanta University

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 21, 2026
• Study Start: February 24, 2024
• Primary Completion: January 9, 2026
• Study Completion: January 12, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)