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

Not Applicable

Completed

• Conditions: Dental Implants
• Interventions: Procedure: Mucogingival surgery

• Registration Number: NCT03498911
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study First Submitted: 2018-04-08
• Study First Submitted QC: 2018-04-08
• Study First Posted: 2018-04-17
• Study Start: 2018-07-10
• Primary Completion: 2022-03-11
• Study Completion: 2022-04-11
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-05
• Last Update Posted: 2022-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
envelope Coronally Advanced Flap (eCAF)	Mucogingival surgery	A mucogingival surgery where an envelope flap is coronally advanced and sutured to cover the mucosal recession
Modified Tunnel Technique (MTT)	Mucogingival surgery	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

Primary Outcome Measures

Name	Time	Method
mean mid-facial recession coverage (mRC)	up to 1 year	mRC measured as a percentage

Secondary Outcome Measures

Name	Time	Method
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
Keratinized tissue thickness (KTT)	6 months and 1 year	KTT gain measured in mm
Patient-reported post-operative pain	2 weeks	Patient-reported post-operative pain, based on VAS scale, measured as numbers from 0 to 10.
Keratinized tissue (KT) gain	6 months and 1 year	KT gain measured in mm

Trial Locations

Locations (1)

University of Michigan School of Dentistry; 🇺🇸 Ann Arbor, Michigan, United States