The Clinical Effect of Implant Placement With a Simultaneous Soft Tissue Allograft

Completed · Not applicable

Conditions studied: Dental Implants

In brief

Dental implant placement and simultaneous grafting using one layer gum graft will result in the same facial ridge contour and soft tissue thickness as one layer of gum graft plus bone graft.

Key facts

Study ID

NCT02139748

Run by

University of Louisville

People needed

28

Starts

2014-07-01

Expected to finish

2015-05-01

Last updated by the study team

2016-12-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Have one edentulous site bordered by 2 teeth in maxillary sites from second premolar to second premolar (maxillary 4 to 13) to receive an implant with simultaneous grafting with an ADM with or without bovine-derived xenograft.
• Healthy persons at least 18 years old.
• Understands and has signed the informed consent.

You may not qualify if…

• Patients with uncontrolled diabetes, immune disease, or any systemic disease that significantly affects the periodontium.
• Previous head and neck radiation.
• Patients who have taken oral bisphosphonates for > 3 years or any IV bisphosphonates.
• Smokers (or other tobacco habits that might interfere with soft tissue healing).
• Patients who need prophylactic antibiotics prior to dental procedures.
• Patients with allergies to any medication or material used in the study, or that would adversely affect study procedures.
• Chemotherapy in the previous 12 months.
• Psychological problems that would interfere with treatment.
• Patients unable or unwilling to sign the informed consent.
• Pregnant subjects will be excluded due to risk of miscarriage.
• Post-treatment Exclusion Criteria
• Failure of patient to follow treatment protocol.
• Failure of implant to osseointegrate.
• Failure of the allograft to heal.
• Unanticipated healing complications that will adversely affect treatment results.

Where it is running

• Graduate Periodontics, University of Louisville School of Dentistry — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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