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Can Modified Coronally Advanced Tunnel be an Alternative in Gingival Phenotype Modification?

Can Modified Coronally Advanced Tunnel be an Alternative to Epithelialized Free Gingival Graft Technique in Gingival Phenotype Modification? A Comparative Controlled Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04690140
Enrollment
50
Registered
2020-12-30
Start date
2019-05-05
Completion date
2020-07-10
Last updated
2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Phenotype

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.

Interventions

PROCEDUREEpithelialized free gingival graft

The Epithelialized free gingival graft placed on the prepared bed.

PROCEDUREModified coronally advanced tunnel technique

Connective tissue graft placed under the prepared tunnel

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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

Sex/Gender
ALL
Age
18 Years to 60 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Gingival ThicknessBaselineGT, 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).
Gingival Thickness (GT)6th weekGT, 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)BaselineKTH, measured from gingival margin to the mucogingival junction (MGJ).

Secondary

MeasureTime frameDescription
Clinical attachment level (CAL)BaselineClinical attachment level (CAL), measured from the cementoenamel junction to the bottom of the gingival sulcus.
Keratinized tissue change (KTC)BaselineKeratinized tissue change (KTC), GT change (GTC), root coverage, clinical attachment gain (CAG) were calculated in millimeters and percentages.
Wound healing index (WHI)6th weekWound healing index (WHI) was recorded two-weeks after surgery. The wound surface was visually inspected and the soft tissue healing was defined as 'uneventful' (score 1), 'slightly disturbed' (score 2) or 'poor' (score 3) based on the presence and severity of the items including patient discomfort, erythema, edema, suppuration and flap dehiscence.
Probing pocket depth (PD)BaselineProbing pocket depth (PD), measured from the gingival margin to the bottom of the gingival sulcus.
Dentine hypersensitivity (DH)6th weekDentine hypersensitivity (DH) was evaluated with air evaporative stimulus method at baseline and T2. After placement of finger(s) for preserving the nearby teeth, the recession sites were subjected to evaporative stimulus comprised of 1-second air blast from 1 to 3 mm distance by using the air spray at 40-65 psi pressure and 19±50C. After application, the patients were requested to give a score to their DH between 0 (=no pain) and 10 (=extreme pain).
Patient expectations (PE)6th weekPatient expectations (PE) were evaluated by requesting from the patients to rate their treatment results at T2, as satisfactory or not, in terms of appearance, experience and obtained root coverage.
Aesthetics (A)6th weekAesthetics (A) was evaluated by the patient at T1 by rating its level as excellent, good, fair or poor.
Tissue appearance (TA)6th weekTissue appearance (TA) was evaluated by asking the patients to score the consistency, contour, color match, keloid formation degree and contiguity of their treated sites at T2. The scores were collected as points, shown in parentheses, by asking the consistency as firm (1p) or spongy (0p); contour as presence (2p) or absence (0p) of knife-edged and scalloped gingival margin; color match as excellent (3p), good (2p), adequate (1p) or unsatisfactory (0p); keloid formation degree as absent (1p) or present (0p); contiguity as the presence (-1p) or absence (0p) of each perceptible incision mark.
Recession Depth (RD)BaselineRD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.
Recession width (RW)BaselineRecession width (RW), the distance between the mesial gingival margin and the distal gingival margin of the tooth measured from the widest point of the recession.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026