Treatment of Gingival Recession With Tunnel Technique Using Connective Tissue Graft and Injectable Platelet Rich Fibrin

NCT ID: NCT06646432

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-09-30

Brief Summary

Gingival recession is a common periodontal problem. Consequences include teeth sensitivity, poor esthetics and impaired oral hygiene access. Mild cases are managed by optimizing oral hygiene measures, correction of any causative factor such as faulty tooth brushing, improper dental restoration or denture clasp. Prescription of desensitization products such as specific tooth gels or mouth washes can manage the sensitivity problem. Deeper recession defects need to be addressed by surgical procedures. Coronally advanced flap with connective tissue graft is the gold standard procedure. However, it has some drawbacks due to the need for papillary incisions and vertical incisions in some cases. Within the era of minimally invasive periodontology, tunnel technique with connective tissue graft showed results comparable to coronally advanced flap with connective tissue graft but with some limitations. Addition of another agent may enhance the results of tunnel technique. Injectable platelet rich fibrin is known for its content of growth factors and effects on soft tissue healing. Aim: The study aim is to compare the surgical management of gingival recession with tunnel technique using connective tissue graft and injectable platelet rich fibrin to tunnel with connective graft without injectable platelet rich fibrin.

Methodology: 30 patients with miller class I or II gingival recession will be enrolled. 15 in the test group (Tunnel+ CTG+ i-PRF) and 15 in control group (Tunnel+ CTG). Clinical evaluation at 6 months

Detailed Description

30 patients with miller class I/II gingival recession will be enrolled in this study.

15 patients will be treated using tunnel technique and palatal connective tissue graft inserted and sutured under the prepared tunnel after being soaked in injectable platelet rich fibrin for 15 minutes. The tunnel with the underlying graft will be advanced coronally. (Test Group) The other 15 patients will be treated the same way as in the first group but without soaking the graft in injectable platelet rich fibrin. (Control Group) Clinical parameters will be evaluated at baseline and 6 months follow-up except post-operative pain which will be assessed after 10 days. Histologic examination of small piece of the graft will be done to assess if there is true saturation of growth factors inside the graft.

Conditions

Gingival Recession

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Test group: tunnel with connective tissue graft and injectable platelet rich fibrin

Tunneling will be performed at the recession defect sites with insertion of palatal connective tissue graft taken from the patient hard palate inside the prepared tunnel. The graft will be soaked ,before insertion inside the tunnel, in injectable platelet rich fibrin ,prepared from patient own blood for 15 minutes. The tunnel with the soaked graft inside will be advanced coronally.

Group Type: EXPERIMENTAL

Tunnel with connective tissue graft and injectable platelet rich fibrin

Intervention Type: PROCEDURE

Tunnel with connective tissue graft and injectable platelet rich fibrin

Control group: tunnel with connective tissue graft only

Tunnel preparation will be made in the recession defect sites with insertion of palatal connective tissue graft from the patient hard palate. The tunnel with the graft will be advanced coronally.

Group Type: ACTIVE_COMPARATOR

Tunnel with connective tissue graft only

Intervention Type: PROCEDURE

Tunnel technique with connective tossue graft only without injectable platelet rich fibrin

Interventions

Tunnel with connective tissue graft and injectable platelet rich fibrin

Tunnel with connective tissue graft and injectable platelet rich fibrin

Intervention Type: PROCEDURE

Tunnel with connective tissue graft only

Tunnel technique with connective tossue graft only without injectable platelet rich fibrin

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• More than 21 years old
• Systemically healthy
• Presence of Miller class I/II gingival recession
• Presence of identifiable CEJ

Exclusion Criteria

• Smoking
• Systemic disease that contraindicates surgical procedures.
• Poor compliance with oral hygiene measures
• Necrotizing gingival conditions
• Ongoing active periodontitis

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suez Canal University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abdelnasser Elrefaey

Role: STUDY_CHAIR

Suez Canal University

Shaimaa Morsy

Role: STUDY_DIRECTOR

Suez Canal University

Locations

Faculty of dentistry, Suez canal university

Ismailia, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohammed Abdel-aziz

Role: CONTACT

mohamed_naser@dent.suez.edu.eg

00201118580817

Facility Contacts

Abdelaziz

Role: primary

mohamed_naser@dent.suez.edu.eg

002+ 01118580817

Other Identifiers

486/2022

Identifier Type: -

Identifier Source: org_study_id