Ridge Preservation Comparing 2 Membranes

NCT ID: NCT01905280

Last Updated: 2016-12-08

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-07-31

Brief Summary

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The purpose of this study is to compare the clinical and histologic outcomes for acellular dermal matrix and a nonresorbable membrane to determine if either provides a significant therapeutic advantage. The hypothesis is that there will be no difference in crestal ridge width between the two treatments.

Detailed Description

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30 patients will be selected that meet the following criteria:

Inclusion Criteria

1. Have one non-molar tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by at least one tooth.
2. Healthy male or female who is at least 18 years old.
3. Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria

1. Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.
2. Presence or history of osteonecrosis of jaws.
3. Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration.
4. Patients who have been treated with oral bisphosphonates for more than three years.
5. Patients with an allergy to any material or medication used in the study.
6. Patients who need prophylactic antibiotics.
7. Previous head and neck radiation therapy.
8. Chemotherapy in the previous 12 months.
9. Patients on long term NSAID or steroid therapy.
10. Pregnant patients.

Conditions

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Alveolar Ridge Deficiency

Keywords

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allograft acellular dermal matrix alveolar ridge

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Acellular dermal matrix

A ridge preservation graft will be performed and then covered using acellular dermal matrix as a membrane.

Group Type EXPERIMENTAL

Acellular dermal matrix

Intervention Type PROCEDURE

The ridge preservation graft will be covered with an acellular dermal matrix allograft during the surgery.

Non-resorbable membrane

A ridge preservation graft will be performed and then covered using a non-resorbable PTFE membrane.

Group Type ACTIVE_COMPARATOR

Non-resorbable membrane

Intervention Type PROCEDURE

The ridge preservation graft will be covered with a non-resorbable PTFE membrane during the surgery.

Interventions

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Non-resorbable membrane

The ridge preservation graft will be covered with a non-resorbable PTFE membrane during the surgery.

Intervention Type PROCEDURE

Acellular dermal matrix

The ridge preservation graft will be covered with an acellular dermal matrix allograft during the surgery.

Intervention Type PROCEDURE

Other Intervention Names

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PTFE or Cytoplast Acellular dermal matrix allograft, Alloderm

Eligibility Criteria

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Inclusion Criteria

1. Have one non-molar tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by at least one tooth.
2. Healthy male or female who is at least 18 years old.
3. Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria

1. Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.
2. Presence or history of osteonecrosis of jaws.
3. Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration.
4. Patients who have been treated with oral bisphosphonates for more than three years.
5. Patients with an allergy to any material or medication used in the study.
6. Patients who need prophylactic antibiotics.
7. Previous head and neck radiation therapy.
8. Chemotherapy in the previous 12 months.
9. Patients on long term NSAID or steroid therapy.
10. Pregnant patients.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Louisville

OTHER

Sponsor Role lead

Responsible Party

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Henry Greenwell

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Henry Greenwell, DMD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

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Graduate Periodontics Clinic University of Louisville

Louisville, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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13.0330

Identifier Type: -

Identifier Source: org_study_id