N/A
N=31
A Comparison of Bone Formation With Three Different Bone Graft Materials Following Sinus Graft
Inadequate Bone Height in Maxillary Posterior Area
Bottom Line
View on ClinicalTrials.gov: NCT01911819 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: The Percentage of Vital Bone in a Total Amount of a Bone Specimen — 10.9; 9.1; 32.0 percentage of vital bone
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sinus augmentation (Procedure); Equimatrix (Drug); OSSIF-i sem (Drug); Bio-oss (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Loma Linda University
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Vital Bone in a Total Amount of a Bone Specimen |
10.9; 9.1; 32.0 | — |
| SECONDARY The Percentage of Non-vital Bone/Residual Bone Graft Material in a Bone. |
34.3; 38.9; 5.5 | — |
Summary
The purpose of this study is to compare new bone formation following bone graft in sinus using three different commercially available bone graft materials. The study hypothesis is that there is no difference in new bone formation among three bone graft materials under microscope.
Eligibility Criteria
Inclusion Criteria
- Over 18 years old who are able to read and sign written consent form.
- Patient who has good oral hygiene (Full-mouth plaque score <25%).
- Subject would be available for study monitoring.
- Patients with missing teeth in the maxillary posterior region who will require sinus augmentation f or implant placement. The patients may be partially or completely edentulous.
- Delayed implant placement approximately 8 months following sinus grafting.
Exclusion Criteria
A medical history that will complicate the outcome of the study such as:
- alcohol, drug dependency,
- signs or symptoms of maxillary sinus disease,
- current smoker,
- history of head and neck radiation treatment,
- poor health or any other medical, physical or psychological reason that might affect the surgical procedure or the subsequent prosthodontic treatment and/or required follow-up examinations.
Data sourced from ClinicalTrials.gov (NCT01911819). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.