Clinical trial NCT03498911: Comparison of Envelope Coronally Advanced Flap and Modified Tunnel Technique in Soft Tissue Dehiscence Around Implants
Official title: Comparison of Envelope Coronally Advanced Flap and Modified Tunnel Technique in Soft Tissue Dehiscence Coverage Around Implants: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implants
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Delta Dental Foundation
First posted: 2018-04-17
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: mean mid-facial recession coverage (mRC)
timeFrame: up to 1 year
Secondary outcomes:
measure: Esthetic score
timeFrame: 6 months and 1 year
measure: Patient-reported esthetics
timeFrame: 6 months and 1 year
measure: Patient-reported post-operative pain
timeFrame: 2 weeks
measure: Keratinized tissue (KT) gain
timeFrame: 6 months and 1 year
measure: Keratinized tissue thickness (KTT)
timeFrame: 6 months and 1 year
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Dentistry
state: Michigan
Study officials:
affiliation: University of Michigan
name: Hom-Lay Wang, DDS MSD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Bassetti RG, Stahli A, Bassetti MA, Sculean A. Soft tissue augmentation around osseointegrated and uncovered dental implants: a systematic review. Clin Oral Investig. 2017 Jan;21(1):53-70. doi: 10.1007/s00784-016-2007-9. Epub 2016 Nov 21.
citation: Anderson LE, Inglehart MR, El-Kholy K, Eber R, Wang HL. Implant associated soft tissue defects in the anterior maxilla: a randomized control trial comparing subepithelial connective tissue graft and acellular dermal matrix allograft. Implant Dent. 2014 Aug;23(4):416-25. doi: 10.1097/ID.0000000000000122.