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NCT Number: NCT07064603

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TCAF

Procedure

tunnel coronal advanced flap

Primary outcomes

  1. Gingival recession depth reduction (GRD)

    Time frame: ONE YEAR

Secondary outcomes

  1. Percentage of mean root coverage (MRC %)

    Time frame: one year

  2. Percentage of complete root coverage (CRC%)

    Time frame: one year

  3. Gingival Recession width

    Time frame: one year

  4. Keratinized tissue width (KTW)

    Time frame: one year

  5. Probing pocket depth

    Time frame: one year

  6. Root coverage esthetic score

    Time frame: one year

    10 is the ideal esthetic score

    Zero points will be assigned if the final position of the gingival margin is equal or apical to the previous recession depth (failure of root coverage procedure), irrespective of color, the presence of a scar, MTC, or MGJ.

    Zero points will also be assigned when a partial or total loss of interproximal papilla (black triangle) occurred following the treatment

  7. Volumetric soft tissue changes

    Time frame: one year

  8. Post-operative pain

    Time frame: 2 Week post-operative

    Visual Analogue Scale (VAS) with numerical scale from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first 2 weeks postoperatively

  9. Post-operative patient satisfaction

    Time frame: one year

    A 3-item questionnaire will be given to the patients to be answered using a 7-point answer scale for assessing their satisfaction with the whole surgical procedure and the achieved results of the procedure performed.

Study contacts

Contact information is provided by the study sponsor or research team.

May Mohamed Kamal

CONTACT

[email protected]

01063392983

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 14, 2025
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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