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Ridge Augmentation Without Primary Closure

University of Louisville (UOFL) logo

University of Louisville (UOFL)

Status

Completed

Conditions

Alveolar Ridge Augmentation

Treatments

Procedure: With primary closure
Procedure: Without primary closure

Study type

Interventional

Funder types

Other

Identifiers

NCT01901783
13.0331

Details and patient eligibility

About

This study is designed to compare the clinical and histologic results of ridge augmentation with and without primary closure over the barrier membrane. The hypothesis is that there will be no difference in crestal ridge width between the two groups.

Full description

A maximum of 30 patients will be selected that meet the following criteria:

Inclusion Criteria

  1. At least a one tooth area with a ridge defect, treatment planned to receive a dental implant. The site must be bordered by at least one tooth.
  2. Healthy person that is at least 18 years old.
  3. Patient understands and signs an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria

  1. Patients with debilitating systemic diseases, diseases that affect the periodontium, or psychological problems that would interfere with treatment.
  2. Previous head and neck radiation or chemotherapy within the previous 12 months.
  3. Patients with known allergy to any of the materials that will be used in the study.
  4. Smokers.
  5. Patients who need prophylactic antibiotics prior to dental procedures.
  6. Patients on long-term steroid therapy or oral bisphosphonates > 3 years or any IV biosphosphonates.
  7. Patients who are pregnant.

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. At least a one tooth area with a ridge defect, treatment planned to receive a dental implant. The site must be bordered by at least one tooth.
  2. Healthy person that is at least 18 years old.
  3. Patient understands and signs an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion criteria

  1. Patients with debilitating systemic diseases, diseases that affect the periodontium, or psychological problems that would interfere with treatment.
  2. Previous head and neck radiation or chemotherapy within the previous 12 months.
  3. Patients with known allergy to any of the materials that will be used in the study.
  4. Smokers.
  5. Patients who need prophylactic antibiotics prior to dental procedures.
  6. Patients on long-term steroid therapy or oral bisphosphonates > 3 years or any IV biosphosphonates.
  7. Patients who are pregnant.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

18 participants in 2 patient groups

With primary closure
Active Comparator group
Description:
The ridge augmentation graft will be covered with a barrier membrane and the soft tissue will be primarily closed.
Treatment:
Procedure: With primary closure
Without primary closure
Experimental group
Description:
The ridge augmentation graft will be covered with a barrier membrane and the soft tissue will not be primarily closed.
Treatment:
Procedure: Without primary closure

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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