Ridge Preservation Comparing an Intrasocket Graft Alone to an Intrasocket Graft Plus a Facial Overlay Graft

• ClinicalTrials.gov Identifier: NCT01431131
• Recruitment Status: Completed
• First Posted: September 9, 2011
• Results First Posted: January 31, 2017
• Last Update Posted: January 31, 2017
• Sponsor: University of Louisville
• Information provided by (Responsible Party): Henry Greenwell, University of Louisville

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Clinical Efficacy	Procedure: Intrasocket graft; Procedure: Intrasocket plus facial overlay graft	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: September 2011
• Actual Primary Completion Date: July 2012
• Actual Study Completion Date: July 2012

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Intrasocket graft; Positive control	Procedure: Intrasocket graft; Intrasocket mineralized cancellous allograft
Experimental: Intrasocket plus facial overlay graft; Intrasocket cancellous allograft plus a facial overlay bovine xenograft	Procedure: Intrasocket plus facial overlay graft; Intrasocket mineralized cancellous allograft plus a facial overlay graft of bovine xenograft

Outcome Measures

Primary Outcome Measures :

1. Horizontal Ridge Dimension [ Time Frame: Baseline and 4 months ]
   WIll be measured with a digital caliper at baseline and 4 months.

Secondary Outcome Measures :

1. Histologic Healing of the Osseous Graft [ Time Frame: 4 months ]
   Histologic analysis to determine vital bone, nonvital bone, and trabecular space percentages

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Kentucky

Graduate Periodontics Clinic, School of Dentistry, University of Louisville

Louisville, Kentucky, United States, 40202

Sponsors and Collaborators

University of Louisville

Investigators

• Principal Investigator: Henry Greenwell, DMD; University of Louisville

More Information

• Responsible Party: Henry Greenwell, Principal Investigator, University of Louisville
• ClinicalTrials.gov Identifier: NCT01431131
• Other Study ID Numbers: 11.0352
• First Posted: September 9, 2011
• Results First Posted: January 31, 2017
• Last Update Posted: January 31, 2017
• Last Verified: December 2016

Keywords provided by Henry Greenwell, University of Louisville:

graft placement; bone resorption