Ridge Augmentation Without Primary Closure

NCT01901783 | Completed

• 1 other identifier: 13.0331
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Alveolar Ridge Augmentation

Keywords

allograft; regeneration; alveolar ridge

Outcome Measures

Primary Outcomes (1)

• Crestal ridge width

  The ridge width at the crest will be compared between the two treatment groups.

  4 months

Secondary Outcomes (1)

• Percent vital bone

  4 months

Study Arms (2)

With primary closure

ACTIVE COMPARATOR

The ridge augmentation graft will be covered with a barrier membrane and the soft tissue will be primarily closed.

Procedure: With primary closure

Without primary closure

EXPERIMENTAL

The ridge augmentation graft will be covered with a barrier membrane and the soft tissue will not be primarily closed.

Procedure: Without primary closure

Interventions

With primary closure PROCEDURE

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.

Also known as: Primary soft tissue closure over the membrane.

With primary closure

Without primary closure PROCEDURE

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.

Also known as: No primary soft tissue closure over the membrane.

Without primary closure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Healthy person that is at least 18 years old.
• Patient understands and signs an informed consent approved by the University of Louisville Human Studies Committee.

You may not qualify if:

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

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

Graduate Periodontics Clinic University of Louisville

Louisville, Kentucky, 40202, United States

Location

Study Officials

• Henry Greenwell, DMD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 12, 2013
• First Posted: July 17, 2013
• Study Start: September 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: December 8, 2016

Record last verified: 2016-12

Locations

US (1)