Ridge Augmentation Without Primary Closure

Ridge Augmentation Comparing the Clinical and Histologic Healing of a Cancellous Block Allograft Plus a Barrier Membrane With and Without Primary Closure

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01901783

Enrollment

Registered

2013-07-17

Start date

2013-09-30

Completion date

2014-06-30

Last updated

2016-12-08

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

Conditions

Alveolar Ridge Augmentation

Keywords

allograft, regeneration, alveolar ridge

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.

Interventions

PROCEDUREWith primary closure

A cancellous block allograft will be placed for ridge augmentation and covered with a barrier membrane. The soft tissue will be primarily closed over the membrane.

PROCEDUREWithout primary closure

A cancellous block allograft will be placed for ridge augmentation and covered with a barrier membrane. The soft tissue will not be primarily closed over the membrane.

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

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.

Design outcomes

Primary

Measure	Time frame	Description
Crestal ridge width	4 months	The ridge width at the crest will be compared between the two treatment groups.

Secondary

Measure	Time frame	Description
Percent vital bone	4 months	The percent vital bone will be compared between the two treatment groups.

Countries

United States

Outcome results

None listed

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