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

NCT ID: NCT06553677

Last Updated: 2024-08-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-31
• Study Completion Date: 2025-09-30

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.

Detailed Description

Gingival recession can cause clinical conditions that could be of main concern for patients. Techniques aiming for coverage of the gingival recession aim to address dentin hypersensitivity, non-carious cervical lesions (NCCLs) and enhance patient's esthetics (Cortellini & Bissada, 2018). Mid-buccal gingival recessions have been associated with patient's esthetic discomfort (Zucchelli & Mounssif, 2015). Most of the studies in the literature focus on the treatment of RT1 recession as they have the most favorable prognosis of full root coverage (Barootchi et al., 2020). Despite most studies focusing their attention on RT1 cases, RT2 defects are found to be the most prevalent type with 88.8% among patients according to (Romandini et al., 2020).

The coronally advanced flap and the tunneling technique are the most commonly performed surgical approaches for treating gingival recessions. However, these two approaches have commonly been regarded as alternatives to each other, with clinicians choosing to perform only one of them during root coverage procedures.

(Barootchi & Tavelli, 2022) aimed in his conducted case series to designate a surgical technique to treat isolated RT2 gingival recession defects in which he was trying to achieve and combine the advantage of both better access and graft stabilization in CAF and the preservation of the integrity of the papilla and better blood supply to the graft present in tunneling technique. The study concluded that the combination of both techniques in the same surgical design can have the potential to enhance flap and graft vascularization and improve clinical, esthetic, and patient-reported outcomes. To our knowledge, there is no conducted randomized clinical trials comparing the tunneled coronally advanced flap technique to the coronally advanced flap for gingival depth reduction.

So, this clinical trial aims to address this gap of the literature.

Conditions

Gingival Recession, Localized

Study Design

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

Study Groups

Tunneled coronal advanced flap with connective tissue graft

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

Group Type: EXPERIMENTAL

Tunneled coronal advanced flap with connective tissue graft

Intervention Type: PROCEDURE

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

Coronally advanced flap with connective tissue graft

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

Group Type: ACTIVE_COMPARATOR

Coronally advanced flap with connective tissue graft

Intervention Type: PROCEDURE

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

Interventions

Tunneled coronal advanced flap with connective tissue graft

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

Intervention Type: PROCEDURE

Coronally advanced flap with connective tissue graft

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Patients age 18 years or older.

2. Isolated recession defect classified as RT2.

3. Patients with healthy systemic condition.

4. Clinical indication and/or patient request for root coverage.

5. O'Leary index less than 20%.

Exclusion Criteria

1. Pregnant females

2. Smokers: a contraindication for any plastic periodontal surgery.

3. Unmotivated and uncooperative patients with poor oral hygiene

4. Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or parafunctional habits.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Omar Hazem Mohamed Said Sallam

Teaching Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Engy Ahmed, PhD

Role: STUDY_CHAIR

Cairo University

Omar A Ashour, PhD

Role: STUDY_CHAIR

Cairo University

Yehia H Amer, PhD

Role: STUDY_CHAIR

Cairo University

Omar H Sallam, MSc

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Faculty of Dentistry, Cairo University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Omar H Sallam, MSc

Role: CONTACT

omar.sallam@dentistry.cu.edu.eg

+201113203236

References

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.

Reference Type: RESULT

PMID: 35175005 (View on PubMed)

Other Identifiers

Perio2804

Identifier Type: -

Identifier Source: org_study_id