A Histomorphometric Analysis Following Sinus Augmentation Using Two Different Bone Graft Materials.

Completed · Not applicable

Conditions studied: Missing Teeth

In brief

The purpose of this investigator-initiated study is to compare new bone formation through histomorphometric analysis following maxillary sinus augmentation using two different bone graft materials. A total of twenty, sinus augmentation via a lateral approach will be performed for subjects requiring sinus augmentation for implant placement and randomly divided into 2 groups. These subjects will receive one of two different bone graft materials: 1) Anorganic bovine bone matrix- InterOss (Group A), 2) Anorganic bovine bone matrix- Bio-oss (Group B). At the time of implant placement (eight months after the sinus augmentation procedure), two bone biopsies will be collected from augmented site for the histomorphometric analysis. The percentage of vital bone will be measured and analyzed statistically, also the following will be measured: percentage of non-vital bone, percentage of non-bone material , and the percentage of connective tissue.

Key facts

Study ID

NCT03059914

Run by

Loma Linda University

People needed

9

Starts

2017-08-10

Expected to finish

2020-06-26

Last updated by the study team

2024-05-01

Who can join

Age: 18 and older, up to 103. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Over 18 years old who are able to read and sign an informed consent form.
• Patient who has good oral hygiene (Full-mouth plaque score <25%).
• Subject would be available for study monitoring and follow-up visits.
• Patients with missing teeth in the maxillary posterior region who will require sinus augmentation for implant placement. The patients may be partially or completely edentulous.
• Patient is a candidate for delayed implant placement approximately 8 months following sinus grafting

You may not qualify if…

• Alcohol, drug dependency.
• Signs or symptoms of chronic maxillary sinus disease.
• Current smoker.
• History of head and neck radiation treatment.
• Poor health, conditions like uncontrolled diabetes, uncontrolled hypertension or other uncontrolled systemic disease.
• Physical or psychological reason that might affect the surgical procedure or the subsequent prosthodontic treatment and/or required follow-up examinations.
• Also, subjects who are nursing or pregnant will be excluded from the study.

Where it is running

• Loma Linda University school of dentistry — Loma Linda, California, United States

Full record on ClinicalTrials.gov

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