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

NCT06646432 | Recruiting

• 1 other identifier: 486/2022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Gingival Recession

Keywords

Tunneling; Gingival recession; Injectable platelet rich fibrin; Minimally invasive periodontology

Outcome Measures

Primary Outcomes (3)

• Recession depth

  it will be recorded as the distance between the CEJ and gingival margin-measurements were performed at the mid-buccal aspect of the teeth, by manual probe and were rounded up to the nearest millimeter.

  6 months after the surgery

• Keratinized tissue height

  It will be measured from the mucogingival junction to the gingival margin-measurements were performed at the mid-buccal aspect of the teeth, by manual probe and were rounded up to the nearest millimeter.

  6 months

• Gingival thickness

  It will be measured at a mid-buccal location 1 mm apical to the probing depth level with an spreader. It will be pierced, perpendicularly to the mucosal surface, through the soft tissue with light pressure until a hard surface is felt. The silicone disk stop will then be placed in tight contact with the soft tissue surface. Penetration depth will be measured.

  6 months

Secondary Outcomes (2)

• Post operative pain

  10 days

• Recession width

  6 months

Study Arms (2)

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

EXPERIMENTAL

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.

Procedure: Tunnel with connective tissue graft and injectable platelet rich fibrin

Control group: tunnel with connective tissue graft only

ACTIVE COMPARATOR

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.

Procedure: Tunnel with connective tissue graft only

Interventions

Tunnel with connective tissue graft and injectable platelet rich fibrin PROCEDURE

Tunnel with connective tissue graft and injectable platelet rich fibrin

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

Tunnel with connective tissue graft only PROCEDURE

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

Control group: tunnel with connective tissue graft only

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Faculty of dentistry, Suez canal university

Ismailia, 41522, Egypt

RECRUITING

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

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

Study Officials

• Abdelnasser Elrefaey

  Suez Canal University

  STUDY CHAIR

• Shaimaa Morsy

  Suez Canal University

  STUDY DIRECTOR

Central Study Contacts

Mohammed Abdel-aziz

CONTACT

00201118580817; mohamed_naser@dent.suez.edu.eg

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: SPONSOR

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 17, 2024
• Study Start: November 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)