Ridge Augmentation: Particulate v/s Block Graft

NCT02487784 | Completed DMC

• 1 other identifier: 15.0530
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary aims of this study are to compare the clinical and histologic results of bone regeneration with a cancellous block allograft versus MinerOss Cortico cancellous particulate allograft mixed with autogenous bone chips after 4 months of healing. Titanium reinforced hd-PTFE (Cytoplast) membrane GBR will be used to cover the bone grafts. Specific Aim 1: To compare the baseline to 4 month change in clinical ridge width and height. Specific Aim 2: To compare the histologic percent of vital and nonvital bone and trabecular space at 4 months. The primary outcome variable is the change in horizontal ridge width. The secondary outcomes are the change in ridge height and the percent histologic composition of the augmented site.

Conditions

Alveolar Bone Loss

Outcome Measures

Primary Outcomes (1)

• Horizontal ridge width changes

  Site width (horizontal) changes by comparing the pre- to the 4 month post- augmentation dimensions of hard tissues.

  4 months

Secondary Outcomes (2)

• Vertical ridge height changes

  4 months

• Histologic composition of the graft

  4 months

Study Arms (2)

Particulate allograft + autogenous bone.

EXPERIMENTAL

In the test arm of the study the treatment will include a mix of MinerOss CorticoCancellous Particulate allograft + autogenous bone chips.

Procedure: Particulate allograft + autogenous bone chips

Block allograft

ACTIVE COMPARATOR

The positive control treatment will include a block allograft plus Mineross corticocancellous particulate allograft.

Procedure: Block allograft

Interventions

Block allograft PROCEDURE

A cancellous block allograft plus corticocancellous particulate allograft will be used as the positive control treatment.

Also known as: Cancellous block allograft

Block allograft

Particulate allograft + autogenous bone chips PROCEDURE

The test arm of this study will include a mix of particulate bone allograft and autogenous bone chips.

Also known as: Particulate + ABC

Particulate allograft + autogenous bone.

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 significantly 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 on oral bisphosphonates \> 3 years or any IV bisphosphonates.
• Patients who are pregnant.

Sponsors & Collaborators

• University of Louisville: lead

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

abacavir

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Henry Greenwell, DMD, MSD

  Director of Graduate Periodontics, School of Dentistry, 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: Director of Graduate Periodontics

Study Record Dates

• First Submitted: June 19, 2015
• First Posted: July 1, 2015
• Study Start: August 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: January 3, 2018

Record last verified: 2017-12