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Recruiting NCT06553677

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

No phase Interventional Gingival Recession, Localized

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tunneled coronal advanced flap with connective tissue graft, Coronally advanced flap with connective tissue graft.
Who it may be relevant to
Registry conditions: Gingival Recession, Localized. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Clinical Evaluation of Tunneled Coronally Advanced Flap (TCAF) Versus Coronally Advanced Flap (CAF) Combined With Connective Tissue Graft in the Treatment of Isolated RT2 Gingival Recession Sites: A Randomized Clinical Trial

Overview

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.

Interventions

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

Primary outcome measures

  • Gingival Recession Depth [Time frame: 6 months]
Secondary outcome measures (11)
  • Percentage of mean root coverage (MRC%) [Time frame: 6 months]
  • Percentage of complete root coverage (CRC%) [Time frame: 6 months]
  • Gingival Recession Width [Time frame: 6 months]
  • Gingival Thickness [Time frame: 6 months]
  • Keratinized Tissue Width [Time frame: 6 months]
  • Clinical Attachment Level [Time frame: 6 months]
  • Probing Pocket Depth [Time frame: 6 months]
  • Pink Esthetic Score [Time frame: 6 months]
  • Post-operative pain [Time frame: 2 weeks]
  • Post-operative patient satisfaction [Time frame: 2 weeks, 6 months]
  • Root coverage esthetic score [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • 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%.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Dentistry, Cairo University — Cairo

Publications

  • 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

Identifiers

NCT: NCT06553677 · Perio2804

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗