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

Gingival Phenotype Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04690140
• Other study ID #: Phenotype Modification
• Status: Completed
• Phase: N/A
• Start date: May 5, 2019
• Est. completion date: July 10, 2020

Study information

• Verified date: December 2020
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 10, 2020
• Est. primary completion date: June 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingival Phenotype

Intervention

Procedure:
• Epithelialized free gingival graft
The Epithelialized free gingival graft placed on the prepared bed.
• Modified coronally advanced tunnel technique
Connective tissue graft placed under the prepared tunnel

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Keratinized Tissue Height (KTH)	KTH, measured from gingival margin to the mucogingival junction (MGJ).	Baseline
Primary	Keratinized Tissue Height (KTH)	KTH, measured from gingival margin to the mucogingival junction (MGJ).	6th week
Primary	Keratinized Tissue Height (KTH)	KTH, measured from gingival margin to the mucogingival junction (MGJ).	6th month
Primary	Keratinized Tissue Height (KTH)	KTH, measured from gingival margin to the mucogingival junction (MGJ).	12th month.
Secondary	Recession Depth (RD)	RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.	Baseline
Secondary	Recession Depth (RD)	RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.	6th week
Secondary	Recession Depth (RD)	RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.	6th month
Secondary	Recession Depth (RD)	RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.	12th month.
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	Probing pocket depth (PD)	Probing pocket depth (PD), measured from the gingival margin to the bottom of the gingival sulcus.	Baseline
Secondary	Probing pocket depth (PD)	Probing pocket depth (PD), measured from the gingival margin to the bottom of the gingival sulcus.	6th week
Secondary	Probing pocket depth (PD)	Probing pocket depth (PD), measured from the gingival margin to the bottom of the gingival sulcus.	6th month
Secondary	Probing pocket depth (PD)	Probing pocket depth (PD), measured from the gingival margin to the bottom of the gingival sulcus.	12th month.
Secondary	Clinical attachment level (CAL)	Clinical attachment level (CAL), measured from the cementoenamel junction to the bottom of the gingival sulcus.	Baseline
Secondary	Clinical attachment level (CAL)	Clinical attachment level (CAL), measured from the cementoenamel junction to the bottom of the gingival sulcus.	6th week
Secondary	Clinical attachment level (CAL)	Clinical attachment level (CAL), measured from the cementoenamel junction to the bottom of the gingival sulcus.	6th month
Secondary	Clinical attachment level (CAL)	Clinical attachment level (CAL), measured from the cementoenamel junction to the bottom of the gingival sulcus.	12th month
Secondary	Keratinized tissue change (KTC)	Keratinized tissue change (KTC), GT change (GTC), root coverage, clinical attachment gain (CAG) were calculated in millimeters and percentages.	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Aesthetics (A)	Aesthetics (A) was evaluated by the patient at T1 by rating its level as excellent, good, fair or poor.	6th week