NCT03498911CompletedNot Applicable
Comparison of Envelope Coronally Advanced Flap and Modified Tunnel Technique in Soft Tissue Dehiscence Coverage Around Implants: A Randomized Clinical Trial
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 28
- Locations
- 2
- Primary Endpoint
- mean mid-facial recession coverage (mRC)
Study Overview
Brief Summary
The purpose of this study is to assess the influence of two different flap designs (envelope Coronally Advanced Flap (eCAF) and Modified Tunnel Technique (MTT)) with the addition of a connective tissue graft (CTG) in treating soft tissue dehiscences at implant sites
Detailed Description
The primary aim is to compare the test and control groups in terms of:
- mean mid-facial recession coverage (mRC) measured as a percentage
- the keratinized tissue (KT) gain measured in mm
- the keratinized tissue thickness (KTT) gain measured in mm.
The secondary aims are to compare the two groups in terms of:
- Esthetic score, using numeric values from 0 to 10
- patient-reported esthetics, using numeric values from 1 to 5
- patient-reported post-operative pain, based on Visual Analog Scale (VAS) scale, measured as numbers from 0 to 10.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years
- •Periodontally and systemically healthy
- •Full-mouth plaque score and full-mouth bleeding score ≤ 20% (measured at four sites per tooth)
- •Correct implant 3-dimensional position or buccal position ≤ 1 mm
- •Buccal soft tissue dehiscence ≤ 4 mm
- •Only osseointegrated implants
- •The patient must be able to perform good oral hygiene
Exclusion Criteria
- •Contraindications for periodontal surgery
- •Patients pregnant or attempting to get pregnant
- •Malpositioned implant
- •Soft tissue dehiscence (STD) > 4 mm
- •Multiple adjacent implants with STD
- •Existing of peri-implantitis
- •Severe bone loss (≥4mm)
- •Moderate-severe interproximal bone loss (implant fixture level to the alveolar bone > 3 mm)
- •Moderate-severe papilla height loss (Nordland and Tarnow implant papillae index >1)
- •Previous mucogingival surgery around the implant within the past six months or implant placement at the surgical site less than six months prior
- •Smoking more than 10 cigarettes a day
Outcomes
Primary Outcomes
mean mid-facial recession coverage (mRC)
Time Frame: up to 1 year
mRC measured as a percentage
Secondary Outcomes
- Esthetic score(6 months and 1 year)
- Patient-reported esthetics(6 months and 1 year)
- Keratinized tissue thickness (KTT)(6 months and 1 year)
- Patient-reported post-operative pain(2 weeks)
- Keratinized tissue (KT) gain(6 months and 1 year)
Investigators
Hom-Lay Wang, DDS, MSD, Ph D
Collegiate Professor of Periodontics and Professor of Dentistry
University of Michigan
Study Sites (2)
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