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

Does the De-epithelialization Procedure Affect the Epithelial Remnants and Recession Coverage Outcomes?

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.

Study Overview

• Status: Completed
• Conditions: Connective Tissue Graft Harvesting
• Intervention / Treatment: Procedure: Intraorally de-epithelialization; Procedure: Extraorally de-epithelialization

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intraoral; 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.	Procedure: 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.
Active Comparator: Extraoral; 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recession reduction	RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.	3rd month
Recession reduction	RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.	6th month
Recession reduction	RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.	12th month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recession width (RW)	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.	6th month
Probing pocket depth (PD)	Probing pocket depth (PD), measured from the gingival margin to the bottom of the gingival sulcus.	6th month
Clinical attachment level (CAL)	Clinical attachment level (CAL), measured from the cementoenamel junction to the bottom of the gingival sulcus.	Baseline
Clinical attachment level (CAL)	Clinical attachment level (CAL), measured from the cementoenamel junction to the bottom of the gingival sulcus.	6th month
Clinical attachment level (CAL)	Clinical attachment level (CAL), measured from the cementoenamel junction to the bottom of the gingival sulcus.	12th month
Keratinized tissue change (KTC)	Keratinized tissue change (KTC), GT change (GTC), root coverage, clinical attachment gain (CAG) were calculated in millimeters and percentages.	6th month
Keratinized tissue change (KTC)	Keratinized tissue change (KTC), GT change (GTC), root coverage, clinical attachment gain (CAG) were calculated in millimeters and percentages.	12th month
amount of deciduous cells	Amount of deciduous cells was measured with computerized microscope via histomorfometric methods.	at the day of the surgery.
percentage of deciduous cells	amount of deciduous cells Amount of deciduous cells was measured with computerized microscope via histomorfometric methods.	at the day of the surgery
Recession Depth (RD)	RD, was measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.	Baseline.
Recession Depth (RD)	RD, was measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.	3rd month
Recession Depth (RD)	RD, was measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.	6th month
Recession Depth (RD)	RD, was measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.	12th month
Keratinized Tissue Height (KTH)	TH, was measured from gingival margin to the mucogingival junction (MGJ).	baseline
Keratinized Tissue Height (KTH)	TH, was measured from gingival margin to the mucogingival junction (MGJ).	3rd month
Keratinized Tissue Height (KTH)	TH, was measured from gingival margin to the mucogingival junction (MGJ).	6th month
Keratinized Tissue Height (KTH)	TH, was measured from gingival margin to the mucogingival junction (MGJ).	12th month
Gingival Thickness (GT)	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).	baseline
Gingival Thickness (GT)	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).	3rd month
Gingival Thickness (GT)	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).	6th month
Gingival Thickness (GT)	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).	12th month
Recession width (RW)	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.	baseline
Recession width (RW)	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.	3rd month
Recession width (RW)	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.	12th month
Probing pocket depth (PD)	Probing pocket depth (PD), measured from the gingival margin to the bottom of the gingival sulcus.	baseline
Probing pocket depth (PD)	Probing pocket depth (PD), measured from the gingival margin to the bottom of the gingival sulcus.	3rd month
Probing pocket depth (PD)	Probing pocket depth (PD), measured from the gingival margin to the bottom of the gingival sulcus.	12th month
Clinical attachment level (CAL)	Clinical attachment level (CAL), measured from the cementoenamel junction to the bottom of the gingival sulcus.	3rd month
Keratinized tissue change (KTC)	Keratinized tissue change (KTC), GT change (GTC), root coverage, clinical attachment gain (CAG) were calculated in millimeters and percentages.	3rd month
Wound healing index (WHI)	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.	3rd month
Wound healing index (WHI)	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.	6th month
Wound healing index (WHI)	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.	12th month
Tissue appearance (TA)	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.	3rd month
Tissue appearance (TA)	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.	6th month
Tissue appearance (TA)	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.	12th month
Dentine hypersensitivity (DH)	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).	3rd month
Dentine hypersensitivity (DH)	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).	6th month
Dentine hypersensitivity (DH)	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).	12th month
Aesthetics (A)	Aesthetics (A) was evaluated by the patient at T1 by rating its level as excellent, good, fair or poor.	3rd month
Aesthetics (A)	Aesthetics (A) was evaluated by the patient at T1 by rating its level as excellent, good, fair or poor.	6th month
Aesthetics (A)	Aesthetics (A) was evaluated by the patient at T1 by rating its level as excellent, good, fair or poor.	12th month
Vestibuler Depth	VD was measured from the gingival margin to the deepest point of to vestibule sulcus.	baseline
Vestibuler Depth	VD was measured from the gingival margin to the deepest point of to vestibule sulcus.	3rd month
Vestibuler Depth	VD was measured from the gingival margin to the deepest point of to vestibule sulcus.	6th month
Vestibuler Depth	VD was measured from the gingival margin to the deepest point of to vestibule sulcus.	12th month

Collaborators and Investigators

• Sponsor: Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2021
• Primary Completion (Actual): July 30, 2022
• Study Completion (Actual): August 5, 2022

Study Registration Dates

• First Submitted: August 7, 2022
• First Submitted That Met QC Criteria: August 7, 2022
• First Posted (Actual): August 9, 2022

Study Record Updates

• Last Update Posted (Actual): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: quality of graft

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No