Clinical and Histological Evaluation of Healos® for Alveolar Ridge Augmentation

William Giannobile

Status and phase

Withdrawn

Phase 4

Conditions

Dental Implantation

Treatments

Procedure: Alveolar ridge augmentation

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01154868

HUM00035937

Details and patient eligibility

About

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.

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

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.