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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02139748

Dental Implants

COMPLETED NA

Clinical Effects of Hard and Soft Tissue Grafting With Dental Implants

NCT03580811

Dental Implants

COMPLETED NA

The Effect of Platform-Matching Versus Platform-Switching Dental Implants on Peri-implant Hard and Soft Tissue Healing

NCT02536716

Missing Tooth

COMPLETED NA

Implant Placement With Simultaneous Gum Grafting

NCT01431144

Edentulous

COMPLETED NA

Soft Tissue Responses Around Nanostructured Calcium-phosphate-coated Implant Abutments on Dental Implants: Histological, Genetic and Clinical Evaluation in Smokers and Non-smokers.

NCT01620918

Missing Several Teeth Minimum of 2 Dental Implants Needed

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Clinical Efficacy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

one layer allograft

One layer allograft as a positive control

Group Type ACTIVE_COMPARATOR

One layer allograft

Intervention Type PROCEDURE

The acellular dermal matrix was placed on the facial surface.

Two layer allograft

Two layer allograft as the test group.

Group Type EXPERIMENTAL

Two layer allograft

Intervention Type PROCEDURE

The acellular dermal matrix was placed on the facial surface.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

One layer allograft

The acellular dermal matrix was placed on the facial surface.

Intervention Type PROCEDURE

Two layer allograft

The acellular dermal matrix was placed on the facial surface.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

One layer of acellular dermal matrix (Alloderm). Two layers of acellular dermal matrix (Alloderm).

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

1. uncontrolled diabetes, immune disease, or any systemic disease that significantly affects the periodontium
2. previous head and neck radiation
3. oral bisphosphonates for \> 3 years or any IV bisphosphonates
4. smoking \> 1/2 pack per day or other tobacco habits that might interfere with soft tissue healing
5. requirement for prophylactic antibiotics
6. allergies to any medication or material used in the study, or that would adversely affect study procedures
7. chemotherapy in the previous 12 months
8. psychological problems that would interfere with treatment
9. patients unable or unwilling to sign the informed consent
10. pregnancy -

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes