Comparison of Envelope Coronally Advanced Flap and Modified Tunnel Technique in Soft Tissue Dehiscence Around Implants

University of Michigan

Status: Completed

Conditions: Dental Implants

Treatments: Procedure: Mucogingival surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03498911

HUM00140205

Details and patient eligibility

About

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

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups

envelope Coronally Advanced Flap (eCAF)

Active Comparator group

Description:

A mucogingival surgery where an envelope flap is coronally advanced and sutured to cover the mucosal recession

Treatment:

Procedure: Mucogingival surgery

Modified Tunnel Technique (MTT)

Experimental group

Description:

A mucogingival surgery where the gingiva is released without reflecting a flap (as described for tunnel techniques) and then coronally advanced and sutured to cover the mucosal recession

Treatment:

Procedure: Mucogingival surgery