Clinical Evaluation of Tunneled Coronally Advanced Flap v.s Coronally Advanced Flap With Graft for Gingival Recession

NCT06553677 | Recruiting DMC

• 1 other identifier: Perio2804
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate gingival recession depth reduction using tunneled coronally advanced flap compared to coronally advanced flap, both combined with connective tissue graft in patients with isolated RT2 gingival recession sites.

Conditions

Gingival Recession, Localized

Keywords

TCAF; CAF; RT2; Gingival recession depth reduction

Outcome Measures

Primary Outcomes (1)

• Gingival Recession Depth

  It's measured as the distance between cemento-enamel junction (CEJ), and gingival margin (GM) using periodontal probe.

  6 months

Secondary Outcomes (11)

• Percentage of mean root coverage (MRC%)

  6 months

• Percentage of complete root coverage (CRC%)

  6 months

• Gingival Recession Width

  6 months

• Gingival Thickness

  6 months

• Keratinized Tissue Width

  6 months

Study Arms (2)

Tunneled coronal advanced flap with connective tissue graft

EXPERIMENTAL

TCAF involves the elevation of one trapezoidal surgical papilla at the papilla with less interproximal clinical attachment loss, by a slightly divergent vertical incision extending beyond the mucogingival junction is done then a horizontal incision at a distance equal to the recession depth plus 1 mm apical to the papilla tip just as the conventional coronally advanced flap (CAF). Then a tunneling knife will be used to perform the intra-sulcular incision on the treated site and on the tooth adjacent to the papilla that will be preserved for tension-free flap advancement. The midfacial aspect of the tooth will be elevated with tunneling knives while the surgical papilla will be elevated in a split-thickness manner. . The anatomical papilla will be de-epithelialized, either with a surgical blade or micro scissors, while the other papilla will be gently mobilized with a tunneling instrument. . The harvested connective tissue graft will be inserted underneath the flap

Procedure: Tunneled coronal advanced flap with connective tissue graft

Coronally advanced flap with connective tissue graft

ACTIVE COMPARATOR

A trapezoidal-shaped flap will be elevated with a split-full-split approach in the coronal-apical direction: * The surgical papillae will be elevated by split thickness keeping the blade almost parallel to the root. * The soft tissue apical to the root exposure will be elevated in a full thickness manner to expose 3-4mm of bone apical to the bone dehiscence. This was done to include the periosteum in the thickness of that central portion of the flap covering the avascular root exposure. * The releasing vertical incisions will be elevated by split thickness keeping the blade parallel to the bone thus leaving the periosteum to protect the underlying bone in the lateral areas of the flap. * The part of the flap apical to bone exposure will be elevated by split-thickness, this step will be done so it is possible to move the flap passively in the coronal direction. The harvested connective tissue graft will be inserted underneath the flap

Procedure: Coronally advanced flap with connective tissue graft

Interventions

Tunneled coronal advanced flap with connective tissue graft PROCEDURE

Tunneled coronal advanced flap with connective tissue graft to treat isolated RT2 gingival recession sites.

Tunneled coronal advanced flap with connective tissue graft

Coronally advanced flap with connective tissue graft PROCEDURE

Coronally advanced flap with connective tissue graft to treat isolated RT2 gingival recession sites

Coronally advanced flap with connective tissue graft

Eligibility Criteria

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

You may qualify if:

• Patients age 18 years or older.
• Isolated recession defect classified as RT2.
• Patients with healthy systemic condition.
• Clinical indication and/or patient request for root coverage.
• O'Leary index less than 20%.

You may not qualify if:

• Pregnant females
• Smokers: a contraindication for any plastic periodontal surgery.
• Unmotivated and uncooperative patients with poor oral hygiene
• Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or parafunctional habits.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

RECRUITING

Related Publications (1)

• Barootchi S, Tavelli L. Tunneled coronally advanced flap for the treatment of isolated gingival recessions with deficient papilla. Int J Esthet Dent. 2022 Feb 17;17(1):14-26.

  PMID: 35175005 RESULT

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

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

Study Officials

• Engy Ahmed, PhD

  Cairo University

  STUDY CHAIR

• Omar A Ashour, PhD

  Cairo University

  STUDY CHAIR

• Yehia H Amer, PhD

  Cairo University

  STUDY CHAIR

• Omar H Sallam, MSc

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Omar H Sallam, MSc

CONTACT

+201113203236; omar.sallam@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Model Details: It's randomized clinical trial

Study Record Dates

• First Submitted: August 11, 2024
• First Posted: August 14, 2024
• Study Start: August 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)