Clinical Evaluation of Platelet Rich Fibrin Membrane With or Without Hyaluronic Acid Along With Coronally Advanced Flap in the Treatment of Rt1 Gingival Recession

NCT07662447 | Active Not Recruiting

• 1 other identifier: NoorMDSperio
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Gingival recession is a common mucogingival deformity that may result in root hypersensitivity, esthetic concern, plaque accumulation, and difficulty in oral hygiene maintenance. Modified coronally advanced flap procedures are widely used for Cairo RT1 gingival recession defects. Platelet-rich fibrin has been used as an autologous biologic adjunct, while hyaluronic acid has shown potential benefits in wound hydration, inflammation modulation, and soft tissue healing. Aim: To evaluate the clinical effectiveness of multilayered platelet-rich fibrin with cross-linked hyaluronic acid compared with platelet-rich fibrin alone in the treatment of Cairo RT1 gingival recession defects using modified coronally advanced flap without vertical releasing incisions.

Conditions

PRF; Gingival Recession; Hyaluronic Acid

Outcome Measures

Primary Outcomes (1)

• Percentage of root coverage

  baseline, 3 months, 6 months

Secondary Outcomes (1)

• postoperative pain VAS score 1-10

  baseline, 3 days, 3 weeks

Study Arms (2)

root coverage with multilayered PRF

ACTIVE COMPARATOR

Procedure: root coverage with multilayered PRF

root coverage with multilayered PRF and hyaluronic acid

EXPERIMENTAL

Procedure: root coverage with multilayered PRF and hyaluronic acid

Interventions

root coverage with multilayered PRF PROCEDURE

root coverage with multilayered PRF

root coverage with multilayered PRF

root coverage with multilayered PRF and hyaluronic acid PROCEDURE

root coverage with multilayered PRF and hyaluronic acid application

root coverage with multilayered PRF and hyaluronic acid

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemically healthy patients aged 18-50 years presenting with Cairo RT1 gingival recession defects were included in the study.
• Patients were selected if the recession defect was present on a vital tooth with an identifiable cementoenamel junction and no interproximal clinical attachment loss.
• The selected tooth was required to be free from caries, cervical restorations, non-carious cervical lesions interfering with measurement, pulpal pathology, and pathological mobility. Patients with acceptable oral hygiene after initial periodontal therapy, preferably with Plaque Index ≤1, were included.
• Patients willing to participate in the study, sign informed consent, and report for all follow-up visits were included.

You may not qualify if:

• Patients with systemic conditions that could affect periodontal wound healing, such as uncontrolled diabetes mellitus, immunosuppressive disorders, bleeding disorders, connective tissue disorders, or any serious systemic illness, were not included. Pregnant or lactating women were excluded from the study.
• Patients taking medications known to influence gingival healing, including corticosteroids, immunosuppressants, bisphosphonates, anticoagulants, or long-term anti-inflammatory drugs, were excluded. Patients with poor oral hygiene, untreated gingival inflammation, active periodontal disease, or recession defects classified as Cairo RT2 or RT3 were not included.
• Teeth with cervical caries, cervical restorations, deep abrasion, erosion, non-carious cervical lesions interfering with CEJ identification, endodontic pathology, periapical lesions, non-vital pulp, traumatic occlusion that could not be corrected before surgery, or previous periodontal plastic surgery at the selected site within the past 12 months were excluded.
• Patients undergoing orthodontic treatment or those who had recently completed orthodontic treatment were also excluded if tooth movement could affect gingival margin stability. Patients unwilling to provide consent or unable to attend the follow-up schedule were not included.

Sponsors & Collaborators

• Gulf Medical University: lead

Study Sites (1)

Gulf Medical University

Ajman, Ajman Emirate, 00000, United Arab Emirates

Location

MeSH Terms

Conditions

Gingival Recession

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 23, 2026
• Study Start: July 1, 2025
• Primary Completion: July 1, 2026
• Study Completion (Estimated): September 10, 2026
• Last Updated: June 23, 2026

Record last verified: 2026-06

Locations

AE (1)