Dental Implants
Conditions
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: 1. mean mid-facial recession coverage (mRC) measured as a percentage 2. the keratinized tissue (KT) gain measured in mm 3. the keratinized tissue thickness (KTT) gain measured in mm. The secondary aims are to compare the two groups in terms of: 1. Esthetic score, using numeric values from 0 to 10 2. patient-reported esthetics, using numeric values from 1 to 5 3. patient-reported post-operative pain, based on Visual Analog Scale (VAS) scale, measured as numbers from 0 to 10.
Interventions
PROCEDUREMucogingival surgery
The gingiva around the mucosal recession at implant site will be coronally positioned by releasing the underlying mucosa
Sponsors
Delta Dental Foundation
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mean mid-facial recession coverage (mRC) | up to 1 year | mRC measured as a percentage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Keratinized tissue (KT) gain | 6 months and 1 year | KT gain measured in mm |
| Keratinized tissue thickness (KTT) | 6 months and 1 year | KTT gain measured in mm |
| Esthetic score | 6 months and 1 year | Esthetic score measured using numeric values from 0 to 10 |
| Patient-reported esthetics | 6 months and 1 year | Patient-reported esthetics measured using numeric values from 1 to 5 |
| Patient-reported post-operative pain | 2 weeks | Patient-reported post-operative pain, based on VAS scale, measured as numbers from 0 to 10. |
Countries
United States
Outcome results
None listed