Phase 4
N=32
Guided Bone Regeneration Around Immediate Implants
Missing Tooth
Bottom Line
View on ClinicalTrials.gov: NCT01628367 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: Change in Thickness of Buccal Bone — .73; .86; .63; .66 millimeters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Minimally Traumatic Tooth Extraction (Procedure); Immediate Implant Placement (Device); Bone Graft Placement (Biological); Membrane placement (Biological); Collagen plug placement (Biological); Medications (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Thickness of Buccal Bone |
.73; .86; .63; .66 | — |
| SECONDARY Change in Interproximal Bone Levels |
1.38; 1.42 | — |
| SECONDARY Pink Esthetic Score |
11.53; 9.88 | — |
Summary
An important result of healing after tooth extraction is a reduction in dimensions of the remaining bone at that site. This reduction of bone volume precludes successful restoration of the space using a dental implant. Bone augmentation has shown promise in clinical reports to reduce this loss of bone volume, thus allowing implant placement and restoration. The purpose of this study is to evaluate the clinical and radiographic outcomes of guided bone regeneration around dental implants placed in fresh extraction sockets.
Eligibility Criteria
Inclusion Criteria
- Males and females aged 18 or older.
- Systemically healthy (American Society of Anesthesiologists I or II).
- Subjects will have one or more anterior or premolar teeth with a hopeless prognosis, with adjacent and opposing teeth present.
- Compliance with all requirements in the study and signing the informed consent
Exclusion Criteria
- Active acute infection at the extraction site (e.g., sinus tract, swelling)
- Absence of sufficient mesio-distal width to place an implant as per the study protocol.
- Absence of sufficient bone height to house a 10mm long implant.
- The subject lacks a stable occlusion and/or a healthy periodontium.
- Current smokers or quit smoking less than one year
- Chronic use of medications known to affect the periodontal status (calcium antagonists, anticonvulsives, immunosuppressives, anti-inflammatory medications)
- Pregnancy or lactating mothers
- Current orthodontic or periodontal treatments
- History of alcoholism or drug abuse
- Untreated deep carious lesions or defective restorations that can potentially exacerbate during the course of the study
- Diseases of the immune system or any medical condition that may influence the outcome (uncontrolled diabetes (HbA1c >7)
- Bone disorders (hyperparathyroidism, osteoporosis, or Paget's disease)
- Neurologic or psychiatric disorders, systemic infections
- A history of IV bisphosphonate use.
Data sourced from ClinicalTrials.gov (NCT01628367). 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.