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Implant Placement and Simultaneous Soft Tissue Grafting With Single or Double Layers of Acellular Dermal Matrix

Implant Placement and Simultaneous Soft Tissue Grafting With Single or Double Layers of Acellular Dermal Matrix: A Randomized, Controlled Clinical Tria.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01902056
Enrollment
26
Registered
2013-07-17
Start date
2012-11-30
Completion date
2013-06-30
Last updated
2013-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical Efficacy

Keywords

allograft, acellular dermal matrix, Alloderm

Brief summary

The purpose of this study is to compare the effect on soft tissue thickness of placing either a single or double layer of acellular dermal matrix simultaneous with dental implant placement. The hypothesis is that 2 layers of acellular dermal matrix will produce thicker tissues that one layer.

Detailed description

Patients must be greater that 18 years old, not pregnant, and have an edentulous space with a tooth on each side that is treatment planned to receive a dental implant. The primary outcome measure is soft tissue thickness.

Interventions

PROCEDUREOne layer allograft

The acellular dermal matrix was placed on the facial surface.

PROCEDURETwo layer allograft

The acellular dermal matrix was placed on the facial surface.

Sponsors

University of Louisville
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

The inclusion criteria were; 1. one edentulous site bordered by 2 teeth in the maxilla or mandible from first molar to first molar treatment planned to receive an implant 2. at least 18 years of age 3. must sign the informed consent -

Exclusion criteria

The

Design outcomes

Primary

MeasureTime frameDescription
Soft tissue thickness.4 monthsDetermining the soft tissue thickness using a tissue probe.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026