Comparison of Different De-epithelialization Techniques of Soft Tissue Grafts.

Not Applicable

Completed

• Conditions: Connective Tissue Graft Harvesting
• Interventions: Procedure: Intraorally de-epithelialization; Procedure: Extraorally de-epithelialization

• Registration Number: NCT05494294
• Lead Sponsor: Hacettepe University

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2021-07-04
• Primary Completion: 2022-07-30
• Status Verified: 2022-08
• Study Completion: 2022-08-05
• Study First Submitted: 2022-08-07
• Study First Submitted QC: 2022-08-07
• Study First Posted: 2022-08-09
• Last Update Submitted: 2022-08-09
• Last Update Posted: 2022-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intraoral	Intraorally de-epithelialization	In this group, the grafts were de-epithelialized at the donor site before harvesting. The calibrated surgeon removed the epithelium with a sharp Kirkland knife under magnification. To be sure of the elimination whole epithelial layer, bleeding was observed. Recipient site was prepared as follows; A after sulculer incision had done (blade 15c) two vertical incions were made from the gingival margin to 3 mm beyond the mucogingival junction A partial-thickness flap was elevated under the recession area and full thickness flap elevated adjacent flap portions. then relasing incisions were made apically from the mucogingival junction. After the preparation of the recipient site, obtained graft was sutured 1 mm apically to the cemento-enamel junction. Finally flap was positioned without tension and stabilized at least 2mm coronally from the cemento-enamel margin with the single interrupted sutures.
Extraoral	Extraorally de-epithelialization	In this group, the grafts were de-epithelialized after graft harvesting. The calibrated surgeon removed the epithelium with 15 c knife under magnification. all remnants were removed under magnification. Same recipient site procedure was conducted in this group.

Primary Outcome Measures

Name	Time	Method
Recession reduction	12th month	RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.

Secondary Outcome Measures

Name	Time	Method
amount of deciduous cells	at the day of the surgery.	Amount of deciduous cells was measured with computerized microscope via histomorfometric methods.
Gingival Thickness (GT)	12th month	GT, was 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).
percentage of deciduous cells	at the day of the surgery	amount of deciduous cells Amount of deciduous cells was measured with computerized microscope via histomorfometric methods.
Recession Depth (RD)	12th month	RD, was measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.
Keratinized Tissue Height (KTH)	12th month	TH, was measured from gingival margin to the mucogingival junction (MGJ).
Recession width (RW)	12th month	Recession 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.
Probing pocket depth (PD)	12th month	Probing pocket depth (PD), measured from the gingival margin to the bottom of the gingival sulcus.
Clinical attachment level (CAL)	12th month	Clinical attachment level (CAL), measured from the cementoenamel junction to the bottom of the gingival sulcus.
Keratinized tissue change (KTC)	12th month	Keratinized tissue change (KTC), GT change (GTC), root coverage, clinical attachment gain (CAG) were calculated in millimeters and percentages.
Wound healing index (WHI)	12th month	Wound 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.
Aesthetics (A)	12th month	Aesthetics (A) was evaluated by the patient at T1 by rating its level as excellent, good, fair or poor.
Tissue appearance (TA)	12th month	Tissue 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.
Dentine hypersensitivity (DH)	12th month	Dentine 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).
Vestibuler Depth	12th month	VD was measured from the gingival margin to the deepest point of to vestibule sulcus.

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Turkey