Clinical trial NCT04690140: Can Modified Coronally Advanced Tunnel be an Alternative in Gingival Phenotype Modification?
Official title: Can Modified Coronally Advanced Tunnel be an Alternative to Epithelialized Free Gingival Graft Technique in Gingival Phenotype Modification? A Comparative Controlled Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Phenotype
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the randomized comparative controlled trial, 50 patients with insufficient keratinized tissue at the anterior mandible were treated with either Modified coronally advanced tunnel or epithelialized free gingival graft. At baseline, 6th week, 6th month, 12th-month visits; keratinized tissue height, gingival thickness, recession depth, recession width, probing depth, and clinical attachment level, were evaluated. Keratinized tissue change, Gingival thickness change, root coverage, clinical attachment gain, and complete root coverage were calculated. Wound healing index, tissue appearance, patient expectations, aesthetics, and dentine hypersensitivity were assessed at baseline and 6th week.


Eligibility criteria: Inclusion Criteria:

* presence of at least two anterior mandibular teeth with keratinized tissue height≤1 mm with gingival thickness ≤1mm
* presence of at least two recession type-1 recessions at mandibular anterior teeth and at least one recession with recession depth ≥2 mm,
* aged between 18-60.

Exclusion Criteria:

* unstable endodontic conditions or presence of any restoration/abrasion,
* tooth mobility, any surgical history or gingival enlargement in the area,
* smoking or alcohol use,
* uncontrolled systemic disease, pregnancy or use of drugs known to affect gingival conditions

Primary outcomes:
measure: Gingival Thickness
timeFrame: Baseline
measure: Gingival Thickness (GT)
timeFrame: 6th week
measure: Gingival Thickness (GT)
timeFrame: 6th month
measure: Gingival Thickness (GT)
timeFrame: 12th month
measure: Keratinized Tissue Height (KTH)
timeFrame: Baseline
measure: Keratinized Tissue Height (KTH)
timeFrame: 6th week
measure: Keratinized Tissue Height (KTH)
timeFrame: 6th month
measure: Keratinized Tissue Height (KTH)
timeFrame: 12th month.
Secondary outcomes:
measure: Recession Depth (RD)
timeFrame: Baseline
measure: Recession Depth (RD)
timeFrame: 6th week
measure: Recession Depth (RD)
timeFrame: 6th month
measure: Recession Depth (RD)
timeFrame: 12th month.
measure: Recession width (RW)
timeFrame: Baseline
measure: Recession width (RW)
timeFrame: 6th week
measure: Recession width (RW)
timeFrame: 6th month
measure: Recession width (RW)
timeFrame: 12th month.
measure: Probing pocket depth (PD)
timeFrame: Baseline
measure: Probing pocket depth (PD)
timeFrame: 6th week
measure: Probing pocket depth (PD)
timeFrame: 6th month
measure: Probing pocket depth (PD)
timeFrame: 12th month.
measure: Clinical attachment level (CAL)
timeFrame: Baseline
measure: Clinical attachment level (CAL)
timeFrame: 6th week
measure: Clinical attachment level (CAL)
timeFrame: 6th month
measure: Clinical attachment level (CAL)
timeFrame: 12th month
measure: Keratinized tissue change (KTC)
timeFrame: Baseline
measure: Keratinized tissue change (KTC)
timeFrame: 6th week
measure: Keratinized tissue change (KTC)
timeFrame: 6th month
measure: Keratinized tissue change (KTC)
timeFrame: 12th month
measure: Wound healing index (WHI)
timeFrame: 6th week
measure: Tissue appearance (TA)
timeFrame: 6th week
measure: Dentine hypersensitivity (DH)
timeFrame: 6th week
measure: Patient expectations (PE)
timeFrame: 6th week
measure: Aesthetics (A)
timeFrame: 6th week
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
citation: Yilmaz BT, Comerdov E, Kutuk C, Nart J, Keceli HG. Modified coronally advanced tunnel versus epithelialized free gingival graft technique in gingival phenotype modification: a comparative randomized controlled clinical trial. Clin Oral Investig. 2022 Oct;26(10):6283-6293. doi: 10.1007/s00784-022-04580-0. Epub 2022 Jun 16.