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

Study Overview
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Brief Summary
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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.

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

Conditions
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Connective Tissue Graft Harvesting

Intervention / Treatment
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* Procedure: Intraorally de-epithelialization
* Procedure: Extraorally de-epithelialization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intraoral<br>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<br>* 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.<br>|
| Active Comparator: Extraoral<br>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<br>* 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.<br>|

What is the study measuring?
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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 |
| --- | --- | --- |
| 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. | 6th 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. | 6th 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. | Baseline | 
| Clinical attachment level (CAL) | Clinical attachment level (CAL), measured from the cementoenamel junction to the bottom of the gingival sulcus. | 3rd month | 
| 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. | 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. | 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 | 
| 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 |