Clinical trial NCT01431131: Ridge Preservation Comparing an Intrasocket Graft Alone to an Intrasocket Graft Plus a Facial Overlay Graft
Official title: Ridge Preservation Comparing a Socket Allograft Alone to a Socket Allograft Plus a Facial Overlay Xenograft: A Clinical and Histologic Study In Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clinical Efficacy
Keywords: graft placement
bone resorption
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2011-09-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Horizontal Ridge Dimension
timeFrame: Baseline and 4 months
Secondary outcomes:
measure: Histologic Healing of the Osseous Graft
timeFrame: 4 months
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Graduate Periodontics Clinic, School of Dentistry, University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Henry Greenwell, DMD
role: PRINCIPAL_INVESTIGATOR
References: