Clinical trial NCT01901783: Ridge Augmentation Without Primary Closure
Official title: Ridge Augmentation Comparing the Clinical and Histologic Healing of a Cancellous Block Allograft Plus a Barrier Membrane With and Without Primary Closure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Ridge Augmentation
Keywords: allograft
regeneration
alveolar ridge
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2013-07-17
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Crestal ridge width
timeFrame: 4 months
Secondary outcomes:
measure: Percent vital bone
timeFrame: 4 months
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Graduate Periodontics Clinic University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Henry Greenwell, DMD
role: PRINCIPAL_INVESTIGATOR
References: