Skip to main content
OpenTrials
Completed

NCT Number: NCT03498911

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

About this study

The primary aim is to compare the test and control groups in terms of:

  • mean mid-facial recession coverage (mRC) measured as a percentage
  • the keratinized tissue (KT) gain measured in mm
  • the keratinized tissue thickness (KTT) gain measured in mm.

The secondary aims are to compare the two groups in terms of:

  • Esthetic score, using numeric values from 0 to 10
  • patient-reported esthetics, using numeric values from 1 to 5
  • patient-reported post-operative pain, based on Visual Analog Scale (VAS) scale, measured as numbers from 0 to 10.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mucogingival surgery

Procedure

The gingiva around the mucosal recession at implant site will be coronally positioned by releasing the underlying mucosa

Primary outcomes

  1. mean mid-facial recession coverage (mRC)

    Time frame: up to 1 year

    mRC measured as a percentage

Secondary outcomes

  1. Esthetic score

    Time frame: 6 months and 1 year

    Esthetic score measured using numeric values from 0 to 10

  2. Patient-reported esthetics

    Time frame: 6 months and 1 year

    Patient-reported esthetics measured using numeric values from 1 to 5

  3. 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.

  4. Keratinized tissue (KT) gain

    Time frame: 6 months and 1 year

    KT gain measured in mm

  5. Keratinized tissue thickness (KTT)

    Time frame: 6 months and 1 year

    KTT gain measured in mm

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Delta Dental Foundation

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Apr 17, 2018
Registry last updated
May 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.