N/A
N=24
Ridge Preservation Comparing an Intrasocket Graft Alone to an Intrasocket Graft Plus a Facial Overlay Graft
Clinical Efficacy
Bottom Line
View on ClinicalTrials.gov: NCT01431131 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Horizontal Ridge Dimension — -1.6; -0.3 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intrasocket graft (Procedure); Intrasocket plus facial overlay graft (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Louisville
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Horizontal Ridge Dimension |
-1.6; -0.3 | — |
| SECONDARY Histologic Healing of the Osseous Graft |
35; 40 | — |
Summary
The purpose of this study is to compare two methods of ridge preservation in the maxillary anterior esthetic zone to determine the best method to establish adequate bone and soft tissue to accommodate implant placement. For the positive control group a mineralized cancellous allograft will be placed in the extraction socket. For the test group a mineralized cancellous allograft will be placed in the extraction socket plus an additional graft will be placed to overlay the facial surface of the socket that will be composed of bovine xenograft material. Outcomes will be clinical horizontal and vertical dimensional change and histologic analysis of the graft material at 4 months post-placement.
Eligibility Criteria
Inclusion Criteria
- Have one non-molar tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by at least one tooth.
- Healthy person that is at least 18 years old.
- Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.
Exclusion Criteria
- Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.
- Molar teeth.
- Presence of or history of osteonecrosis of the jaws.
- Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of the duration.
- Patients who have been treated with oral bisphosphonates for more than three years.
- Pregnant women due to the possibility of miscarriage.
- Patients with an allergy to any material or medication used in the study.
- Patients who need prophylactic antibiotics.
- Previous head and neck radiation therapy.
- Chemotherapy in the previous 12 months.
- Patients on long term NSAID or steroid therapy.
Data sourced from ClinicalTrials.gov (NCT01431131). 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.