A Randomized Control Trial Testing Connective Tissue Grafts vs. Allograft on Dental Implants

Not Applicable

Completed

• Conditions: Dental Implant Soft Tissue Defects in the Anterior Maxilla

• Registration Number: NCT01934530
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2012-05
• Study Completion: 2012-07
• Study First Submitted: 2013-08-29
• Study First Submitted QC: 2013-08-29
• Study First Posted: 2013-09-04
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recession Correction	6 Months	Change in recession was recorded at baseline, 6 weeks, 3 months and 6 months after grafting.

Secondary Outcome Measures

Name	Time	Method
Concavity Correction	6 Months	At baseline, 6 weeks, 3 months, and 6 months after grafting, buccal concavities were measured.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States