Clinical trial NCT05494294: Comparison of Different De-epithelialization Techniques of Soft Tissue Grafts.
Official title: Does the De-epithelialization Procedure Affect the Epithelial Remnants and Recession Coverage Outcomes?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Connective Tissue Graft Harvesting
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this randomized comparative controlled clinical trial, 50 patients with single recession defects with thin phenotype were treated with coronally advanced flap. The connective tissue graft was obtained by removing the keratinized layer of the tissue. Removal of the epithelium was achieved by to different approach. At first group epithelium and remnants were removed extraorally whereas others were intraorally. After the removal, obtained graft laid on a lamella, and residual keratinocytes were observed under the microscope. Amount of recession reduction recorded at the 6th week, 6th month, 12th month, and keratinized tissue height, gingival thickness, recession depth, recession width, probing depth, and clinical attachment level, were also 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.


Eligibility criteria: Inclusion Criteria:

* Single tooth recession more than 2mm
* Gingival thickness less than 1mm

Exclusion Criteria:

* unstable endodontic conditions or presence of any restoration/abrasion,
* tooth mobility, any surgical history or gingival enlargement in the area,
* smoking
* uncontrolled systemic disease, pregnancy or use of drugs known to affect gingival conditions

Primary outcomes:
measure: Recession reduction
timeFrame: 3rd month
measure: Recession reduction
timeFrame: 6th month
measure: Recession reduction
timeFrame: 12th month
Secondary outcomes:
measure: amount of deciduous cells
timeFrame: at the day of the surgery.
measure: percentage of deciduous cells
timeFrame: at the day of the surgery
measure: Recession Depth (RD)
timeFrame: Baseline.
measure: Recession Depth (RD)
timeFrame: 3rd month
measure: Recession Depth (RD)
timeFrame: 6th month
measure: Recession Depth (RD)
timeFrame: 12th month
measure: Keratinized Tissue Height (KTH)
timeFrame: baseline
measure: Keratinized Tissue Height (KTH)
timeFrame: 3rd month
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: 3rd month
measure: Gingival Thickness (GT)
timeFrame: 6th month
measure: Gingival Thickness (GT)
timeFrame: 12th month
measure: Recession width (RW)
timeFrame: baseline
measure: Recession width (RW)
timeFrame: 3rd month
measure: Recession width (RW)
timeFrame: 6th month
measure: Recession width (RW)
timeFrame: 12th month
measure: Probing pocket depth (PD)
timeFrame: baseline
measure: Probing pocket depth (PD)
timeFrame: 3rd month
measure: Probing pocket depth (PD)
timeFrame: 6th month
measure: Probing pocket depth (PD)
timeFrame: 12th month
measure: Clinical attachment level (CAL)
timeFrame: Baseline
measure: Clinical attachment level (CAL)
timeFrame: 3rd month
measure: Clinical attachment level (CAL)
timeFrame: 6th month
measure: Clinical attachment level (CAL)
timeFrame: 12th month
measure: Keratinized tissue change (KTC)
timeFrame: 3rd month
measure: Keratinized tissue change (KTC)
timeFrame: 6th month
measure: Keratinized tissue change (KTC)
timeFrame: 12th month
measure: Wound healing index (WHI)
timeFrame: 3rd month
measure: Wound healing index (WHI)
timeFrame: 6th month
measure: Wound healing index (WHI)
timeFrame: 12th month
measure: Tissue appearance (TA)
timeFrame: 3rd month
measure: Tissue appearance (TA)
timeFrame: 6th month
measure: Tissue appearance (TA)
timeFrame: 12th month
measure: Dentine hypersensitivity (DH)
timeFrame: 3rd month
measure: Dentine hypersensitivity (DH)
timeFrame: 6th month
measure: Dentine hypersensitivity (DH)
timeFrame: 12th month
measure: Aesthetics (A)
timeFrame: 3rd month
measure: Aesthetics (A)
timeFrame: 6th month
measure: Aesthetics (A)
timeFrame: 12th month
measure: Vestibuler Depth
timeFrame: baseline
measure: Vestibuler Depth
timeFrame: 3rd month
measure: Vestibuler Depth
timeFrame: 6th month
measure: Vestibuler Depth
timeFrame: 12th month
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References: