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NCT Number: NCT06553677

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Cairo University

Cairo, Egypt

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Tunneled coronal advanced flap with connective tissue graft

Procedure

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

Coronally advanced flap with connective tissue graft

Procedure

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

Primary outcomes

  1. Gingival Recession Depth

    Time frame: 6 months

    It's measured as the distance between cemento-enamel junction (CEJ), and gingival margin (GM) using periodontal probe.

Secondary outcomes

  1. Percentage of mean root coverage (MRC%)

    Time frame: 6 months

    (Preoperative vertical recession depth - Postoperative vertical recession/preoperative vertical recession) x 100 [%]

  2. Percentage of complete root coverage (CRC%)

    Time frame: 6 months

    Number of defect sites with complete root coverage/ Total number of recession sites treated x 100 [%]

  3. Gingival Recession Width

    Time frame: 6 months

    Measured at the widest point (it is the distance between the mesial gingival margin and the distal gingival margin of the tooth)

  4. Gingival Thickness

    Time frame: 6 months

    Measured using transgingival needle probing using anesthesic needle a rubber stopper

  5. Keratinized Tissue Width

    Time frame: 6 months

    Measured as the distance between the gingival margin and the mucogingival junction (MGJ).

  6. Clinical Attachment Level

    Time frame: 6 months

    Measured from the CEJ to the bottom of the gingival sulcus.

  7. Probing Pocket Depth

    Time frame: 6 months

    Measured from the gingival margin to the bottom of the gingival sulcus.

  8. Pink Esthetic Score

    Time frame: 6 months

    It's a score by (Fürhauser et al., 2005) based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color and texture.

    Each variable is assessed with a 0-1-2 score, with 2 being the best and 0 being the poorest score.

  9. Post-operative pain

    Time frame: 2 weeks

    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.

  10. Post-operative patient satisfaction

    Time frame: 2 weeks, 6 months

    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.

  11. Root coverage esthetic score

    Time frame: 6 months

    (Cairo et al., 2009) This score evaluates five variables: level of the gingival margin (GM) , marginal tissue contour (MTC), soft tissue texture (STT) , mucogingival junction (MGJ) alignment , and gingival color (GC).

    • GM: Zero point for failure of root coverage (gingival margin apical or equal to the baseline recession); 3 points partial root coverage; 6 points CRC.
    • MTC: Zero point irregular gingival margin (does not follow the CEJ); 1 point -proper marginal contour/ scalloped gingival margin (follows the CEJ).
    • STT: Zero point for scar formation and/or keloid-like appearance; I point absence of scar or keloid formation.
    • MGJ: Zero point -MGJ not aligned with the MGJ of adjacent teeth; 1 point if the MGJ aligned with the MGJ of adjacent teeth.
    • GC: Zero point color of tissue varies from gingival color at adjacent teeth; 1 point normal color and integration with the adjacent soft tissues.

    10 is the ideal esthetic score

Study contacts

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

Omar H Sallam, MSc

CONTACT

[email protected]

+201113203236

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 Isolated RT2 Gingival Recession Sites: A Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 14, 2024
Registry last updated
Aug 14, 2024

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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