Jaw, Edentulous, Partially
Conditions
Brief summary
To compare a flapless technique of alveolar ridge preservation to a flap technique to determine if preserving the periosteal blood supply would prevent loss of crestal ridge width and height.
Detailed description
Twenty-four patients will randomly be assigned to receive ridge preservation using either flapless or flap technique. Twelve test patients will receive ridge preservation using a flapless approach and twelve control patients will receive ridge preservation using a flap technique. All sockets will be grafted with demineralized bone matrix and mineralized particulate allograft and covered with calcium sulfate barrier. Re-entry surgery will be performed at 4 months when a trephine core will be taken from the grafted site immediately prior to implant placement and submitted for histologic processing.
Interventions
PROCEDURERidge Preservation
Ridge Preservation using demineralized bone matrix and mineralized particulate allograft and covered with calcium sulfate barrier.
Sponsors
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Have one non-molar tooth requiring extraction that will be replaced with a dental implant where at least one adjacent tooth is present 2. Study subjects at least 18 years old 3. Patients must sign an informed consent approved by the University of Louisville Human Studies Committee of Institutional Review Board.
Exclusion criteria
1. Patients with debilitating systemic disease, or a disease affects the periodontium 2. Have an allergy to any material or medication used in the study 3. Require prophylactic antibiotics 4. Previous head and neck radiation therapy 5. Chemotherapy in the previous 12 months 6. Patients taking long term Non-steroidal Anti-inflammatory Drugs or steroid therapy 7. Smoked more than one pack of cigarettes per day
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Crestal Horizontal Ridge Width | 4 months after surgery | Changes in post-extraction to 4 month change in ridge measurements at the alveolar crest and 5 mm apical to crest. Measurements taken with a caliper. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent osseous tissue | 4 months after surgery | A trephine core will be harvested at 4 months. Following histologic processing the osseous core will be classified into percent vital bone, nonvital bone and trabecular space |
Outcome results
None listed