Clinical Efficacy
Conditions
Keywords
graft placement, bone resorption
Brief 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.
Detailed description
Subjects met the eligibility criteria if they were at least 18 years of age and had one nonmolar tooth requiring extraction that would be replaced by a dental implant. Extraction sites were bordered by at least one tooth. Exclusion criteria included: 1) debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium; 2) molar extraction sites; 3) presence of or history of osteonecrosis of the jaws; 4) history of IV bisphosphonate treatment; 5) history of oral bisphosphonate treatment for more than three years; 6) pregnancy or lactation; 7) known allergy to any material or medication used in the study; 8) required antibiotic prophylaxis; 9) previous head and neck radiation therapy; 10) history of chemotherapy in the last 12 months; 11) long term steroid or non-steroidal anti-inflammatory drug therapy; or 12) failure to sign an informed consent approved by the Human Studies Committee. Patients were excluded post-treatment if they developed infection or had an adverse reaction to any of the materials used in the study.
Interventions
PROCEDUREIntrasocket graft
Intrasocket mineralized cancellous allograft
PROCEDUREIntrasocket plus facial overlay graft
Intrasocket mineralized cancellous allograft plus a facial overlay graft of bovine xenograft
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 by a dental implant. The site must be bordered by at least one tooth. 2. Healthy person that is at least 18 years old. 3. Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.
Exclusion criteria
1. Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium. 2. Molar teeth. 3. Presence of or history of osteonecrosis of the jaws. 4. Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of the duration. 5. Patients who have been treated with oral bisphosphonates for more than three years. 6. Pregnant women due to the possibility of miscarriage. 7. Patients with an allergy to any material or medication used in the study. 8. Patients who need prophylactic antibiotics. 9. Previous head and neck radiation therapy. 10. Chemotherapy in the previous 12 months. 11. Patients on long term NSAID or steroid therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Horizontal Ridge Dimension | Baseline and 4 months | WIll be measured with a digital caliper at baseline and 4 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Histologic Healing of the Osseous Graft | 4 months | Histologic analysis to determine vital bone, nonvital bone, and trabecular space percentages |
Countries
United States
Participant flow
Recruitment details
The study was conducted between September 2011 and July 2012 in the Graduate Periodontics clinic at the University of Louisville School of Dentistry.
Participants by arm
| Arm | Count |
|---|---|
| Intrasocket Graft Positive control, an intrasocket cancellous allograft was placed | 12 |
| Intrasocket Plus Facial Overlay Graft Intrasocket cancellous allograft plus a facial overlay bovine xenograft | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Intrasocket Plus Facial Overlay Graft | Intrasocket Graft | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 20 Participants |
| Age, Continuous | 58 years STANDARD_DEVIATION 11 | 52 years STANDARD_DEVIATION 16 | 55 years STANDARD_DEVIATION 14 |
| Gender Female | 5 Participants | 8 Participants | 13 Participants |
| Gender Male | 7 Participants | 4 Participants | 11 Participants |
| Region of Enrollment United States | 12 participants | 12 participants | 24 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Horizontal Ridge Dimension
WIll be measured with a digital caliper at baseline and 4 months.
Time frame: Baseline and 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intrasocket Graft | Horizontal Ridge Dimension | -1.6 mm | Standard Deviation 0.8 |
| Intrasocket Plus Facial Overlay Graft | Horizontal Ridge Dimension | -0.3 mm | Standard Deviation 0.9 |
Secondary
Histologic Healing of the Osseous Graft
Histologic analysis to determine vital bone, nonvital bone, and trabecular space percentages
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intrasocket Graft | Histologic Healing of the Osseous Graft | 35 percentage vital bone | Standard Deviation 16 |
| Intrasocket Plus Facial Overlay Graft | Histologic Healing of the Osseous Graft | 40 percentage vital bone | Standard Deviation 16 |