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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03498911
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : April 6, 2020
Sponsor:
Collaborator:
Delta Dental Foundation
Information provided by (Responsible Party):
Hom-Lay Wang, DDS, MSD, Ph D, 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

Condition or disease Intervention/treatment Phase
Dental Implants Procedure: Mucogingival surgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Envelope Coronally Advanced Flap and Modified Tunnel Technique in Soft Tissue Dehiscence Coverage Around Implants: A Randomized Clinical Trial
Actual Study Start Date : July 10, 2018
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2021

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




Primary Outcome Measures :
  1. mean mid-facial recession coverage (mRC) [ Time Frame: up to 1 year ]
    mRC measured as a percentage


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498911


Contacts
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Contact: Hom-Lay Wang, DDS MSD PhD +1 (734) 7633383 homlay@umich.edu
Contact: Lorenzo Tavelli, DDS +1 (734) 6044364 tavelli@umich.edu

Locations
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United States, Michigan
University of Michigan School of Dentistry Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Lorenzo Tavelli, DDS         
Sponsors and Collaborators
University of Michigan
Delta Dental Foundation
Investigators
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Principal Investigator: Hom-Lay Wang, DDS MSD PhD University of Michigan
Publications of Results:

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Responsible Party: Hom-Lay Wang, DDS, MSD, Ph D, Collegiate Professor of Periodontics and Professor of Dentistry, University of Michigan
ClinicalTrials.gov Identifier: NCT03498911    
Other Study ID Numbers: HUM00140205
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 6, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No