Clinical trial NCT05777811: The Relationship Between Root Coverage Procedures and Buccal Vestibular Depth
Official title: Effect of Different Recession Coverage Approaches on Sites With Shallow Vestibule Depth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shallow Vestibular Depth
Gingival Recession
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this comparative trial, 50 patients with shallow vestibules and Type 1/2 recessions will be treated with either a vertically coronally advanced flap + connective tissue graft or a free gingival graft. At baseline, 3rd-month, 6th-month, and 12th-month visits, the following parameters will be evaluated: buccal vestibular depth, keratinized tissue height, gingival thickness, recession depth, recession width, probing depth, and clinical attachment level. Keratinized tissue change, gingival thickness change, root coverage, clinical attachment gain, and complete root coverage will be calculated. The wound healing index, tissue appearance, patient expectations, aesthetics, and dentin hypersensitivity will be assessed at baseline and at the 6th week.

Detailed description: Buccal vestibule depth was recorded using two different measurement methods. First, the distance between the cementoenamel junction and the deepest point of the vestibule sulcus was measured and recorded as VD1. Then, the distance between the gingival margin and the base of the vestibule sulcus was measured and recorded as VD2.

Eligibility criteria: Inclusion Criteria:

* full-mouth plaque and bleeding scores \<15%
* the presence of at least one recession type-1/2 recession and at least one recession with recession depth ≥ 2 mm
* the presence of an identifiable cemento-enamel junction

Exclusion Criteria:

* Vestibule depth \> 6mm
* Smoking \> 10 cigarettes per day
* Any contraindications for periodontal surgery
* Unstable endodontic conditions or presence of any restoration.

Primary outcomes:
measure: Vestibule depth 2
timeFrame: Baseline
measure: Vestibule depth 2
timeFrame: 3rd month
measure: Vestibule depth 2
timeFrame: 6th month
measure: Vestibule depth 2
timeFrame: 12th month.
measure: Vestibule depth 1
timeFrame: Baseline
measure: Vestibule depth 1
timeFrame: 3rd month
measure: Vestibule depth 1
timeFrame: 6th month
measure: Vestibule depth 1
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: Probing depth (PD)
timeFrame: Baseline
measure: Probing depth (PD)
timeFrame: 6th week
measure: Probing depth (PD)
timeFrame: 6th month
measure: Probing 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 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.
measure: Gingival thickness (GT)
timeFrame: Baseline.
measure: Gingival thickness (GT)
timeFrame: 6th week.
measure: Gingival thickness (GT)
timeFrame: 6th month.
measure: Gingival thickness (GT)
timeFrame: 12th month.
measure: Wound healing index (WHI)
timeFrame: 2nd 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: