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Clinical Trials/NCT01934530
NCT01934530
Completed
Not Applicable

Implant Associated Soft Tissue Defects in the Anterior Maxilla: A Randomized Control Trial Between Subepithelial Connective Tissue Graft and Acellular Dermal Matrix Allograft

University of Michigan1 site in 1 country13 target enrollmentAugust 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Implant Soft Tissue Defects in the Anterior Maxilla
Sponsor
University of Michigan
Enrollment
13
Locations
1
Primary Endpoint
Recession Correction
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

This randomized controlled clinical pilot trial compared the efficacy of two soft tissue grafting methods for correcting esthetic discrepancies associated with non-molar implants in the maxilla. Specifically, it was explored whether defects treated with connective tissue grafts (SCTG) differed in their outcomes from defects treated with acellular dermal matrix allografts (ADM).

Detailed Description

Thirteen patients who presented with implants displaying recession, thin biotype, concavity defects or a combination thereof associated with single crowned dental implants participated in this randomized control trial. The control group (N=7) received SCTG and the test group (N=6) received ADM, both under coronally positioned flaps. Data were collected before surgery, and 6 weeks, 3 months, and 6 months after the surgery. Outcome measures included soft tissue, hard tissue, and esthetics parameters and psychosocial data.

Registry
clinicaltrials.gov
Start Date
August 2009
End Date
July 2012
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Healthy adults of at least 18 years of age
  • Maxillary non-molar implant with failing pink esthetic profile
  • Implants with adjacent landmarks (only one can be an implant)
  • Healthy implants measured by the lack of peri-implantitis and mucositis
  • Good oral hygiene.

Exclusion Criteria

  • Unstable systemic diseases, compromised immune system, or unstable bleeding disorders
  • History of radiation or cancer in the oral cavity
  • Use of IV bisphosphonate or steroid medication
  • Use of tobacco products (\>1/2 pack per day)
  • Pregnancy
  • Mucogingival surgery or implant placement within the past six months

Outcomes

Primary Outcomes

Recession Correction

Time Frame: 6 Months

Change in recession was recorded at baseline, 6 weeks, 3 months and 6 months after grafting.

Secondary Outcomes

  • Concavity Correction(6 Months)

Study Sites (1)

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