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Not yet recruiting NCT07239180

Clinical Evaluation Comparing Tunneled Coronally Advanced Flap and Modified Coronally Advanced Tunnel With Connective Tissue Graft for Managing Single Gum Recession

No phase Interventional Single Recession Defects (RT2)

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: Modified Coronally Advanced Tunnel with Connective Tissue Graft, Tunneled Coronally Advance Flap with Connective Tissue Graft.
Who it may be relevant to
Registry conditions: Single Recession Defects (RT2). 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 Advance Flap (TCAF) Versus Modified Coronally Advanced Tunnel With Connective Tissue Graft in Management of Single Recession Defects (RT2): A Randomized Clinical Trial

Overview

The technique under investigation aims to provide effective root coverage while offering the advantage of being less invasive.

Detailed description

Limited RCTs have been found in the literature comparing the root coverage capacity of the tunneled coronally advanced flap versus modified coronally advanced tunnel combined with connective tissue graft in single RT2 defects. So, this trial aims to fill this gap of knowledge.

Interventions

  • Procedure Modified Coronally Advanced Tunnel with Connective Tissue Graft
    Modified coronally advanced tunnel with connective tissue graft without vertical releasing incisions
  • Procedure Tunneled Coronally Advance Flap with Connective Tissue Graft
    Tunneled coronally advance flap with connective tissue graft with one vertical releasing incision

Primary outcome measures

  • Gingival Recession Depth (GRD) [Time frame: 6 months]
Secondary outcome measures (12)
  • The Percentage of Mean Root Coverage (MRC %) [Time frame: 6 months]
  • Complete Root Coverage (CRC) [Time frame: 6 months]
  • Root Coverage Esthetic Score (RES) [Time frame: 6 months]
  • The Distance between the contact point and the top of the papilla (DCP) [Time frame: 6 months]
  • Gingival Recession Width (RW) [Time frame: 6 months]
  • Probing Pocket Depth (PPD) [Time frame: 6 months]
  • Clinical Attachment Level (CAL) [Time frame: 6 months]
  • Gingival Index (GI) [Time frame: 6 months]
  • Plaque Index (PI) [Time frame: 6 months]
  • Keratinized Tissue Width (KTW) [Time frame: 6 months]
  • Gingival Thickness (GT) [Time frame: 6 months]
  • Postoperative Patient Satisfaction (Visual Analogue Scale) [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • Patients with single RT2 gingival recession defect ≥ 2 mm
  • Age >18 years old.
  • Systemically healthy patients with no contraindications for periodontal surgeries.
  • Gingival and plaque index less than 20%.
  • No previous surgeries at the defect site.
  • Accepts 6 months follow-up period (compliant patients).

Exclusion criteria

  • RT1 gingival recession.
  • Smokers >10 cigarettes a day a contraindicating for any plastic periodontal surgery.
  • Poor oral hygiene.
  • Active periodontitis patients.
  • Patients on medications causing gingival enlargement.
  • Pregnancy.
  • Teeth mobility ≥ 1 mm.
  • Patients using fixed or removable orthodontic appliances.
  • Restoration and/or periapical radiolucency at the defect site.

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
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07239180 · CairoU PhD protocol for Khaled

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗