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Not yet recruiting NCT07064603

Clinical Evaluation of (TCAF) Versus (CAF) Combined With Connective Tissue Graft in the Treatment of Multiple RT2 Gingival Recession Sites

No phase Interventional Gingival Recession, Plastic Surgery

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: TCAF.
Who it may be relevant to
Registry conditions: Gingival Recession, Plastic Surgery. 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
Center list to be confirmed — check the primary protocol.
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 Multiple RT2 Gingival Recession Sites: A Randomized Controlled Clinical Trial

Overview

the aim of the study is to evaluate the changes in gingival recession depth reduction following, treatment of multiple RT2 recession with tunnel coronal advanced flap in comparison to coronal advanced flap, both combined with connective tissue graft

Detailed description

Several techniques for gingival recession defects have been developed for treatment such as are pedicle soft-tissue graft (rotational flap procedures, advanced flap procedure and tunneling), free soft-tissue graft (epithelialized and subepithelial connective tissue graft) and regenerative procedures (barrier membrane or biologic mediators.

The coronally advanced flap and the tunneling technique are the most commonly performed surgical approaches for treating gingival recessions. Barootchi et al. 2024 conducted a clinical study using tunnel coronal advanced flap technique(TCAF) for treating multiple RT2 gingival recession defects ,in order to 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. From the previous study it was concluded that the combination of both techniques in the same surgical design can improve both the flap and graft vascularization and enhance 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 in multiple RT2 recessions.

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

Interventions

  • Procedure TCAF
    tunnel coronal advanced flap

Primary outcome measures

  • Gingival recession depth reduction (GRD) [Time frame: ONE YEAR]
Secondary outcome measures (9)
  • Percentage of mean root coverage (MRC %) [Time frame: one year]
  • Percentage of complete root coverage (CRC%) [Time frame: one year]
  • Gingival Recession width [Time frame: one year]
  • Keratinized tissue width (KTW) [Time frame: one year]
  • Probing pocket depth [Time frame: one year]
  • Root coverage esthetic score [Time frame: one year]
  • Volumetric soft tissue changes [Time frame: one year]
  • Post-operative pain [Time frame: 2 Week post-operative]
  • Post-operative patient satisfaction [Time frame: one year]

Eligibility criteria

Inclusion criteria

  • Patients age 18 years or older.
  • Multiple adjacent recession defect classified as RT2.
  • Patients with healthy systemic condition (Mazzotti et al., 2023).
  • An esthetic concern or hypersensitivity associated with GR
  • The gingival recessions must have at least 1.5 mm of KTW.
  • Presence of an identified CEJ (A step ≤ 1mm of the CEJ level)

Exclusion criteria

  • Full-mouth plaque and bleeding scores >20 (O'Leary et al., 1972)
  • Patients with active periodontal disease;
  • Intake of any medications known to affect gingival homeostasis or to interfere with wound healing
  • Pregnancy and nursing women
  • Smokers: a contraindication for any plastic periodontal surgery (Khuller, 2009).
  • Absence of cervical restorations, crowding or malalignment

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07064603 · 2025-17-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗