N/A
N=59
Efficacy of Socket Grafting for Alveolar Ridge Preservation
Atrophy of Edentulous Alveolar Ridge
Bottom Line
View on ClinicalTrials.gov: NCT01794806 ↗Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Alveolar Ridge Volumetric Changes — -8.36; -15.83 percentage of volume change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tooth extraction and grafting with allograft (Procedure); Tooth extraction (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Iowa
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Alveolar Ridge Volumetric Changes |
-8.36; -15.83 | — |
| SECONDARY Changes in Bucco-lingual Ridge Dimension |
-1.0; -1.8 | — |
| SECONDARY Changes in Apico-coronal Ridge Dimension |
-0.61; -1.17 | — |
Summary
The purpose of this study is to clinically and radiographically assess whether the use of a ridge preservation technique significantly minimizes alveolar ridge resorption following tooth extraction.
Eligibility Criteria
Inclusion Criteria
- Age: 18 to 75 years.
- Gender: No restriction.
- Subjects must require a single-rooted tooth extraction (Tooth deemed as periodontally and/or restoratively hopeless), except lower incisors and second premolars.
- Subjects must be able and willing to follow instructions related to the study procedures.
- Subjects must have read, understood and signed an informed consent form.
Exclusion Criteria
- Reported allergy or hypersensitivity to any of the products to be used in the study.
- Severe hematologic disorders, such as hemophilia or leukemia.
- Active severe infectious diseases that may compromise normal healing.
- Liver or kidney dysfunction/failure.
- Currently under cancer treatment or within 18 months from completion of radio- or chemotherapy.
- Subjects who have a long-term history of oral bisphosphonate use (i.e. 10 years or more).
- Subjects with a history of IV bisphosphonates.
- Subjects with uncontrolled diabetes.
- Subjects with severe metabolic bone diseases, such as Paget's disease of bone, will be excluded.
- Pregnant women or nursing mothers.
- Smokers: Subjects who have smoked within 6 months of study onset.
- Concomitant medications: Subjects on concomitant drug therapy for systemic conditions that may affect the outcomes of the study will not be included in the study.
NOTE: Occasional, short-term use (7-14 days) of analgesics or common cold medications is permitted. Use of such medications will be reviewed and recorded by the investigator.
- Any other non-specified reason that from the point of views of the investigators will make a candidate not a suitable subject for the study (e.g. limited mouth opening).
Data sourced from ClinicalTrials.gov (NCT01794806). 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.