Clinical trial NCT06553677: Clinical Evaluation of Tunneled Coronally Advanced Flap v.s Coronally Advanced Flap With Graft for Gingival Recession
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gingival Recession, Localized
Keywords: TCAF
CAF
RT2
Gingival recession depth reduction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-08-14
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It's randomized clinical trial
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients age 18 years or older.
2. Isolated recession defect classified as RT2.
3. Patients with healthy systemic condition.
4. Clinical indication and/or patient request for root coverage.
5. O'Leary index less than 20%.

Exclusion Criteria:

1. Pregnant females
2. Smokers: a contraindication for any plastic periodontal surgery.
3. Unmotivated and uncooperative patients with poor oral hygiene
4. Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or parafunctional habits.

Primary outcomes:
measure: Gingival Recession Depth
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of mean root coverage (MRC%)
timeFrame: 6 months
measure: Percentage of complete root coverage (CRC%)
timeFrame: 6 months
measure: Gingival Recession Width
timeFrame: 6 months
measure: Gingival Thickness
timeFrame: 6 months
measure: Keratinized Tissue Width
timeFrame: 6 months
measure: Clinical Attachment Level
timeFrame: 6 months
measure: Probing Pocket Depth
timeFrame: 6 months
measure: Pink Esthetic Score
timeFrame: 6 months
measure: Post-operative pain
timeFrame: 2 weeks
measure: Post-operative patient satisfaction
timeFrame: 2 weeks, 6 months
measure: Root coverage esthetic score
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
Study officials:
affiliation: Cairo University
name: Engy Ahmed, PhD
role: STUDY_CHAIR
affiliation: Cairo University
name: Omar A Ashour, PhD
role: STUDY_CHAIR
affiliation: Cairo University
name: Yehia H Amer, PhD
role: STUDY_CHAIR
affiliation: Cairo University
name: Omar H Sallam, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.