Can Modified Coronally Advanced Tunnel be an Alternative in Gingival Phenotype Modification?

Study Overview
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Brief Summary
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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.

Official Title
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Can Modified Coronally Advanced Tunnel be an Alternative to Epithelialized Free Gingival Graft Technique in Gingival Phenotype Modification? A Comparative Controlled Randomized Clinical Trial

Conditions
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Gingival Phenotype

Intervention / Treatment
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* Procedure: Epithelialized free gingival graft
* Procedure: Modified coronally advanced tunnel technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: presence of at least two anterior mandibular teeth with keratinized tissue height≤1 mm with gingival thickness ≤1mm presence of at least two recession type-1 recessions at mandibular anterior teeth and at least one recession with recession depth ≥2 mm, aged between 18-60. Exclusion Criteria: unstable endodontic conditions or presence of any restoration/abrasion, tooth mobility, any surgical history or gingival enlargement in the area, smoking or alcohol use, uncontrolled systemic disease, pregnancy or use of drugs known to affect gingival conditions
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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: modified coronally advanced tunnel technique<br>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. | Procedure: Modified coronally advanced tunnel technique<br>* Connective tissue graft placed under the prepared tunnel<br>|
| Active Comparator: epithelialized free gingival graft<br>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. | Procedure: Epithelialized free gingival graft<br>* The Epithelialized free gingival graft placed on the prepared bed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recession Depth (RD) | RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin. | Baseline | 
| Recession Depth (RD) | RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin. | 6th week | 
| Recession Depth (RD) | RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin. | 6th month | 
| Recession Depth (RD) | RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin. | 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. | 6th week | 
| 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. | 6th week | 
| 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. | 6th week | 
| 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. | Baseline | 
| Keratinized tissue change (KTC) | Keratinized tissue change (KTC), GT change (GTC), root coverage, clinical attachment gain (CAG) were calculated in millimeters and percentages. | 6th week | 
| 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. | 6th week | 
| 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 week | 
| 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 week | 
| Patient expectations (PE) | Patient expectations (PE) were evaluated by requesting from the patients to rate their treatment results at T2, as satisfactory or not, in terms of appearance, experience and obtained root coverage. | 6th week | 
| Aesthetics (A) | Aesthetics (A) was evaluated by the patient at T1 by rating its level as excellent, good, fair or poor. | 6th week |