NCT03498911

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 17, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

July 10, 2018

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2022

Completed
Last Updated

May 9, 2022

Status Verified

May 1, 2022

Enrollment Period

3.7 years

First QC Date

April 8, 2018

Last Update Submit

May 5, 2022

Conditions

Dental Implants

Outcome Measures

Primary Outcomes (1)

  • mean mid-facial recession coverage (mRC)

    mRC measured as a percentage

    up to 1 year

Secondary Outcomes (5)

  • Esthetic score

    6 months and 1 year

  • Patient-reported esthetics

    6 months and 1 year

  • Patient-reported post-operative pain

    2 weeks

  • Keratinized tissue (KT) gain

    6 months and 1 year

  • Keratinized tissue thickness (KTT)

    6 months and 1 year

Study Arms (2)

envelope Coronally Advanced Flap (eCAF)

ACTIVE COMPARATOR

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

Procedure: Mucogingival surgery

Modified Tunnel Technique (MTT)

EXPERIMENTAL

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

Interventions

Mucogingival surgeryPROCEDURE

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

Modified Tunnel Technique (MTT)envelope Coronally Advanced Flap (eCAF)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (9)

  • Zucchelli G, Mazzotti C, Mounssif I, Mele M, Stefanini M, Montebugnoli L. A novel surgical-prosthetic approach for soft tissue dehiscence coverage around single implant. Clin Oral Implants Res. 2013 Sep;24(9):957-62. doi: 10.1111/clr.12003. Epub 2012 Aug 27.

    PMID: 22924841RESULT

  • Sculean A, Chappuis V, Cosgarea R. Coverage of mucosal recessions at dental implants. Periodontol 2000. 2017 Feb;73(1):134-140. doi: 10.1111/prd.12178.

    PMID: 28000282RESULT

  • Schwarz F, Mihatovic I, Shirakata Y, Becker J, Bosshardt D, Sculean A. Treatment of soft tissue recessions at titanium implants using a resorbable collagen matrix: a pilot study. Clin Oral Implants Res. 2014 Jan;25(1):110-5. doi: 10.1111/clr.12042. Epub 2012 Oct 31.

    PMID: 23113567RESULT

  • Roccuzzo M, Gaudioso L, Bunino M, Dalmasso P. Surgical treatment of buccal soft tissue recessions around single implants: 1-year results from a prospective pilot study. Clin Oral Implants Res. 2014 Jun;25(6):641-6. doi: 10.1111/clr.12149. Epub 2013 Apr 15.

    PMID: 23582029RESULT

  • Morelli T, Neiva R, Nevins ML, McGuire MK, Scheyer ET, Oh TJ, Braun TM, Nor JE, Bates D, Giannobile WV. Angiogenic biomarkers and healing of living cellular constructs. J Dent Res. 2011 Apr;90(4):456-62. doi: 10.1177/0022034510389334. Epub 2011 Jan 19.

    PMID: 21248359RESULT

  • Burkhardt R, Joss A, Lang NP. Soft tissue dehiscence coverage around endosseous implants: a prospective cohort study. Clin Oral Implants Res. 2008 May;19(5):451-7. doi: 10.1111/j.1600-0501.2007.01497.x. Epub 2008 Mar 26.

    PMID: 18371102RESULT

  • Bassetti RG, Stahli A, Bassetti MA, Sculean A. Soft tissue augmentation around osseointegrated and uncovered dental implants: a systematic review. Clin Oral Investig. 2017 Jan;21(1):53-70. doi: 10.1007/s00784-016-2007-9. Epub 2016 Nov 21.

    PMID: 27873018RESULT

  • Anderson LE, Inglehart MR, El-Kholy K, Eber R, Wang HL. Implant associated soft tissue defects in the anterior maxilla: a randomized control trial comparing subepithelial connective tissue graft and acellular dermal matrix allograft. Implant Dent. 2014 Aug;23(4):416-25. doi: 10.1097/ID.0000000000000122.

    PMID: 25033346RESULT

  • Tavelli L, Majzoub J, Kauffmann F, Rodriguez MV, Mancini L, Chan HL, Kripfgans OD, Giannobile WV, Wang HL, Barootchi S. Coronally advanced flap versus tunnel technique for the treatment of peri-implant soft tissue dehiscences with the connective tissue graft: A randomized, controlled clinical trial. J Clin Periodontol. 2023 Jul;50(7):980-995. doi: 10.1111/jcpe.13806. Epub 2023 Apr 4.

    PMID: 36935199DERIVED

Study Officials

  • Hom-Lay Wang, DDS MSD PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Collegiate Professor of Periodontics and Professor of Dentistry

Study Record Dates

First Submitted

April 8, 2018

First Posted

April 17, 2018

Study Start

July 10, 2018

Primary Completion

March 11, 2022

Study Completion

April 11, 2022

Last Updated

May 9, 2022

Record last verified: 2022-05

Locations

US(1)