Clinical and Histological Evaluation of Healos® for Alveolar Ridge Augmentation

Phase 4

Withdrawn

• Conditions: Dental Implantation
• Interventions: Procedure: Alveolar ridge augmentation

• Registration Number: NCT01154868
• Lead Sponsor: William Giannobile

Brief Summary

The purpose of this study is to document and evaluate how a bone graft material (Healos®) can help rebuild bone width. Dental implants can only be placed when enough bone is found and this bone graft may help to rebuild bone width for dental implant placement. The ultimate goal of this study is to evaluate how this graft material can help bone healing.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-29
• Study First Submitted QC: 2010-06-30
• Study First Posted: 2010-07-01
• Study Start: 2010-08
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-11
• Last Update Posted: 2015-12-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• age 21 and older
• 2-4 ADJACENT maxillary front teeth missing
• require ridge augmentation and dental implant
• nonsmoker for at least 6 months
• willing to follow oral hygiene instruction and other study instruction
• able to read, understand and sign informed consent

Exclusion Criteria

• Residual upper jaw bone equal to or narrower than 3mm.
• Insufficient gum tissue to obtain wound closure after surgery.
• Clinically significant or unstable (as defined by the investigators) systemic diseases affecting bone or soft tissue growth; or other kidney, liver, heart, thyroid, blood, autoimmune or acute infectious diseases that makes interpretation of the data more difficult
• A history of head & neck radiation treatment due to certain medical conditions.
• Taking steroids, tetracycline or tetracycline analogs, bone therapeutic levels of fluorides, bisphosphonates, medications affecting bone turnover, antibiotics for >7 days or any investigational drug
• Pregnancy or become pregnant during the length of the study
• Wearing removable partial dentures that may put pressure over the area where the bone graft will be placed.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healos	Alveolar ridge augmentation	-

Primary Outcome Measures

Name	Time	Method
horizontal (width) bone gain or loss in millimeters.	18 weeks

Secondary Outcome Measures

Name	Time	Method
radiographic bone changes measured using computer tomography	18 weeks
percentage of new bone formation in the alveolar bone core biopsies.	18 weeks

Trial Locations

Locations (1)

Michigan Center for Oral Health Research; 🇺🇸 Ann Arbor, Michigan, United States