NCT04690140

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 30, 2020

Completed
Last Updated

March 6, 2024

Status Verified

December 1, 2020

Enrollment Period

1.1 years

First QC Date

December 17, 2020

Last Update Submit

March 5, 2024

Conditions

Gingival Phenotype

Outcome Measures

Primary Outcomes (8)

  • Gingival Thickness

    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).

    Baseline

  • Gingival Thickness (GT)

    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).

    6th week

  • Gingival Thickness (GT)

    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).

    6th month

  • Gingival Thickness (GT)

    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).

    12th month

  • Keratinized Tissue Height (KTH)

    KTH, measured from gingival margin to the mucogingival junction (MGJ).

    Baseline

  • Keratinized Tissue Height (KTH)

    KTH, measured from gingival margin to the mucogingival junction (MGJ).

    6th week

  • Keratinized Tissue Height (KTH)

    KTH, measured from gingival margin to the mucogingival junction (MGJ).

    6th month

  • Keratinized Tissue Height (KTH)

    KTH, measured from gingival margin to the mucogingival junction (MGJ).

    12th month.

Secondary Outcomes (25)

  • Recession Depth (RD)

    Baseline

  • Recession Depth (RD)

    6th week

  • Recession Depth (RD)

    6th month

  • Recession Depth (RD)

    12th month.

  • Recession width (RW)

    Baseline

  • +20 more secondary outcomes

Study Arms (2)

modified coronally advanced tunnel technique

ACTIVE COMPARATOR

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.

Procedure: Modified coronally advanced tunnel technique

epithelialized free gingival graft

ACTIVE COMPARATOR

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.

Procedure: Epithelialized free gingival graft

Interventions

Epithelialized free gingival graftPROCEDURE

The Epithelialized free gingival graft placed on the prepared bed.

epithelialized free gingival graft
Modified coronally advanced tunnel techniquePROCEDURE

Connective tissue graft placed under the prepared tunnel

modified coronally advanced tunnel technique

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 35708779DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Dr.

Study Record Dates

First Submitted

December 17, 2020

First Posted

December 30, 2020

Study Start

May 5, 2019

Primary Completion

June 5, 2020

Study Completion

July 10, 2020

Last Updated

March 6, 2024

Record last verified: 2020-12

Locations

TU(1)