Can Modified Coronally Advanced Tunnel be an Alternative to Epithelialized Free Gingival Graft Technique in Gingival Phenotype Modification? A Comparative Controlled Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hacettepe University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Gingival Thickness (GT)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Patients were randomly assigned into modified coronally advanced tunnel (n=25) and epithelialized free gingival graft (n=25) groups by one of the authors with an allocation ratio of 1:1 by using a computer-generated program after successful completion of phase I periodontal treatment. One calibrated author masked to the applied surgical technique recorded all clinical variables. The labeled envelope containing the intervention name was opened by the surgeon.
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
modified coronally advanced tunnel technique
Initial sulcular incisions and flap separation were then carried out with tunnel knives. Dissection was extended at least 8 mm apically to the mucogingival junction and the muscle attachments were removed with curettes so that the flap could be moved in a coronal direction without tension. Interdental papillae were undermined to prepare the bed for connective tissue graft placement. Connective tissue graft was then inserted under the tunnel at the sites of recession and retracted laterally by sutures towards each end of the tunnel. After connective tissue graft positioning, the flap was gently stretched coronally to obtain passive flap closure. The exposed connective tissue was covered by connecting the adjacent flap margins with additional sutures.
Intervention: Modified coronally advanced tunnel technique (Procedure)
epithelialized free gingival graft
A partial-thickness flap was elevated (blade #15c) with horizontal incisions at the cemento-enamel junction level of the adjacent teeth. Then, two vertical incisions extending to the apical were made from two ends of the horizontal incision. The epithelium in the framed region was removed with a scalpel and the underlying connective tissue was exposed. To achieve the best vascularization from the recipient site, bed preparation was completed with a split-thickness horizontal incision that joins the vertical incisions in the apical region.
Intervention: Epithelialized free gingival graft (Procedure)
Outcomes
Primary Outcomes
Gingival Thickness (GT)
Time Frame: 12th month
GT, measured at the mid-point location between the gingival margin and mucogingival junction, using an endodontic spreader (#25 endodontic spreader, 25 mm; D-perfect, Shenzhen, China).
Gingival Thickness
Time Frame: Baseline
GT, measured at the midpoint location between the gingival margin and mucogingival junction, using an endodontic spreader (#25 endodontic spreader, 25 mm; D-perfect, Shenzhen, China).
Keratinized Tissue Height (KTH)
Time Frame: 12th month.
KTH, measured from gingival margin to the mucogingival junction (MGJ).
Gingival Thickness (GT)
Time Frame: 6th week
GT, measured at the mid-point location between the gingival margin and mucogingival junction, using an endodontic spreader (#25 endodontic spreader, 25 mm; D-perfect, Shenzhen, China).
Gingival Thickness (GT)
Time Frame: 6th month
GT, measured at the mid-point location between the gingival margin and mucogingival junction, using an endodontic spreader (#25 endodontic spreader, 25 mm; D-perfect, Shenzhen, China).
Keratinized Tissue Height (KTH)
Time Frame: Baseline
KTH, measured from gingival margin to the mucogingival junction (MGJ).
Keratinized Tissue Height (KTH)
Time Frame: 6th week
KTH, measured from gingival margin to the mucogingival junction (MGJ).
Keratinized Tissue Height (KTH)
Time Frame: 6th month
KTH, measured from gingival margin to the mucogingival junction (MGJ).
Secondary Outcomes
- Probing pocket depth (PD)(12th month.)
- Keratinized tissue change (KTC)(12th month)
- Wound healing index (WHI)(6th week)
- Aesthetics (A)(6th week)
- Recession Depth (RD)(12th month.)
- Recession width (RW)(12th month.)
- Clinical attachment level (CAL)(12th month)
- Patient expectations (PE)(6th week)
- Tissue appearance (TA)(6th week)
- Dentine hypersensitivity (DH)(6th week)
- Recession Depth (RD)(Baseline)
- Recession Depth (RD)(6th week)
- Recession Depth (RD)(6th month)
- Recession width (RW)(Baseline)
- Recession width (RW)(6th week)
- Recession width (RW)(6th month)
- Probing pocket depth (PD)(Baseline)
- Probing pocket depth (PD)(6th week)
- Probing pocket depth (PD)(6th month)
- Clinical attachment level (CAL)(Baseline)
- Clinical attachment level (CAL)(6th week)
- Clinical attachment level (CAL)(6th month)
- Keratinized tissue change (KTC)(Baseline)
- Keratinized tissue change (KTC)(6th week)
- Keratinized tissue change (KTC)(6th month)
Investigators
Gencay Keceli
Assoc. Prof. Dr.
Hacettepe University