Hacettepe University
Ankara, 06100, Turkey (Türkiye)
NCT Number: NCT04690140
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.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Ankara, 06100, Turkey (Türkiye)
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The Epithelialized free gingival graft placed on the prepared bed.
Connective tissue graft placed under the prepared tunnel
Time frame: Baseline
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).
Time frame: 6th week
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).
Time frame: 6th month
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).
Time frame: 12th month
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).
Time frame: Baseline
KTH, measured from gingival margin to the mucogingival junction (MGJ).
Time frame: 6th week
KTH, measured from gingival margin to the mucogingival junction (MGJ).
Time frame: 6th month
KTH, measured from gingival margin to the mucogingival junction (MGJ).
Time frame: 12th month.
KTH, measured from gingival margin to the mucogingival junction (MGJ).
Time frame: Baseline
RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.
Time frame: 6th week
RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.
Time frame: 6th month
RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.
Time frame: 12th month.
RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.
Time frame: Baseline
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.
Time frame: 6th week
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.
Time frame: 6th 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.
Time frame: 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.
Time frame: Baseline
Probing pocket depth (PD), measured from the gingival margin to the bottom of the gingival sulcus.
Time frame: 6th week
Probing pocket depth (PD), measured from the gingival margin to the bottom of the gingival sulcus.
Time frame: 6th month
Probing pocket depth (PD), measured from the gingival margin to the bottom of the gingival sulcus.
Time frame: 12th month.
Probing pocket depth (PD), measured from the gingival margin to the bottom of the gingival sulcus.
Time frame: Baseline
Clinical attachment level (CAL), measured from the cementoenamel junction to the bottom of the gingival sulcus.
Time frame: 6th week
Clinical attachment level (CAL), measured from the cementoenamel junction to the bottom of the gingival sulcus.
Time frame: 6th month
Clinical attachment level (CAL), measured from the cementoenamel junction to the bottom of the gingival sulcus.
Time frame: 12th month
Clinical attachment level (CAL), measured from the cementoenamel junction to the bottom of the gingival sulcus.
Time frame: Baseline
Keratinized tissue change (KTC), GT change (GTC), root coverage, clinical attachment gain (CAG) were calculated in millimeters and percentages.
Time frame: 6th week
Keratinized tissue change (KTC), GT change (GTC), root coverage, clinical attachment gain (CAG) were calculated in millimeters and percentages.
Time frame: 6th month
Keratinized tissue change (KTC), GT change (GTC), root coverage, clinical attachment gain (CAG) were calculated in millimeters and percentages.
Time frame: 12th month
Keratinized tissue change (KTC), GT change (GTC), root coverage, clinical attachment gain (CAG) were calculated in millimeters and percentages.
Time frame: 6th week
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.
Time frame: 6th week
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.
Time frame: 6th week
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).
Time frame: 6th week
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.
Time frame: 6th week
Aesthetics (A) was evaluated by the patient at T1 by rating its level as excellent, good, fair or poor.
Hacettepe University
Other
Can Modified Coronally Advanced Tunnel be an Alternative to Epithelialized Free Gingival Graft Technique in Gingival Phenotype Modification? A Comparative Controlled Randomized Clinical Trial
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