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

May 5, 2022 updated by: Hom-Lay Wang, DDS, MSD, Ph D, University of Michigan

Comparison of Envelope Coronally Advanced Flap and Modified Tunnel Technique in Soft Tissue Dehiscence Coverage Around Implants: A Randomized Clinical Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: envelope Coronally Advanced Flap (eCAF)
A mucogingival surgery where an envelope flap is coronally advanced and sutured to cover the mucosal recession
Procedure: Mucogingival surgery
The gingiva around the mucosal recession at implant site will be coronally positioned by releasing the underlying mucosa
Experimental: Modified Tunnel Technique (MTT)
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
Procedure: Mucogingival surgery
The gingiva around the mucosal recession at implant site will be coronally positioned by releasing the underlying mucosa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean mid-facial recession coverage (mRC)
Time Frame: up to 1 year
mRC measured as a percentage
up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Keratinized tissue (KT) gain
Time Frame: 6 months and 1 year
KT gain measured in mm
6 months and 1 year
Esthetic score
Time Frame: 6 months and 1 year
Esthetic score measured using numeric values from 0 to 10
6 months and 1 year
Patient-reported esthetics
Time Frame: 6 months and 1 year
Patient-reported esthetics measured using numeric values from 1 to 5
6 months and 1 year
Patient-reported post-operative pain
Time Frame: 2 weeks
Patient-reported post-operative pain, based on VAS scale, measured as numbers from 0 to 10.
2 weeks
Keratinized tissue thickness (KTT)
Time Frame: 6 months and 1 year
KTT gain measured in mm
6 months and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

Delta Dental Foundation

Investigators

  • Principal Investigator: Hom-Lay Wang, DDS MSD PhD, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2018

Primary Completion (Actual)

March 11, 2022

Study Completion (Actual)

April 11, 2022

Study Registration Dates

First Submitted

April 8, 2018

First Submitted That Met QC Criteria

April 8, 2018

First Posted (Actual)

April 17, 2018

Study Record Updates

Last Update Posted (Actual)

May 9, 2022

Last Update Submitted That Met QC Criteria

May 5, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • HUM00140205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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