NCT04690140|Completed
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Sponsor study identifier
interventional
50
1 country
1
Study Start
May 5, 2019
Actual (reported)Primary Completion
June 5, 2020
Actual (reported)Study Completion
July 10, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 10, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 5, 2019
Actual (reported)June 5, 2020
Actual (reported)July 10, 2020
Actual (reported)December 17, 2020
Actual (reported)December 30, 2020
Actual (reported)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.
Recession Depth (RD)
Baseline
Recession Depth (RD)
6th week
Recession Depth (RD)
6th month
Recession Depth (RD)
12th month.
Recession width (RW)
Baseline
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.
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.
The Epithelialized free gingival graft placed on the prepared bed.
Connective tissue graft placed under the prepared tunnel
Hacettepe University
Ankara, 06100, Turkey (Türkiye)
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.
50 participants (actual enrollment reported by the registry).
First Submitted
December 17, 2020
First Posted
December 30, 2020
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Study Start
May 5, 2019
Actual (reported)Primary Completion
June 5, 2020
Actual (reported)Study Completion
July 10, 2020
Actual (reported)Last Updated
March 6, 2024
Record last verified: 2020-12
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Source: ClinicalTrials.gov.
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