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

Dental Implants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03498911
• Other study ID #: HUM00140205
• Status: Completed
• Phase: N/A
• Start date: July 10, 2018
• Est. completion date: April 11, 2022

Study information

• Verified date: May 2022
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 11, 2022
• Est. primary completion date: March 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Implants

Intervention

Procedure:
• Mucogingival surgery
The gingiva around the mucosal recession at implant site will be coronally positioned by releasing the underlying mucosa

Locations

Country	Name	City	State
United States	University of Michigan School of Dentistry	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Delta Dental Foundation

Country where clinical trial is conducted

United States, 

References & Publications (8)

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 Au — View Citation

Bassetti RG, Stähli 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. Review. — View Citation

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. — View Citation

Morelli T, Neiva R, Nevins ML, McGuire MK, Scheyer ET, Oh TJ, Braun TM, Nör 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. — View Citation

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 — View Citation

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 2 — View Citation

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. Review. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean mid-facial recession coverage (mRC)	mRC measured as a percentage	up to 1 year
Secondary	Esthetic score	Esthetic score measured using numeric values from 0 to 10	6 months and 1 year
Secondary	Patient-reported esthetics	Patient-reported esthetics measured using numeric values from 1 to 5	6 months and 1 year
Secondary	Patient-reported post-operative pain	Patient-reported post-operative pain, based on VAS scale, measured as numbers from 0 to 10.	2 weeks
Secondary	Keratinized tissue (KT) gain	KT gain measured in mm	6 months and 1 year
Secondary	Keratinized tissue thickness (KTT)	KTT gain measured in mm	6 months and 1 year