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

NCT01431131 | Completed Results

• 1 other identifier: 11.0352
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Clinical Efficacy

Keywords

graft placement; bone resorption

Outcome Measures

Primary Outcomes (1)

• Horizontal Ridge Dimension

  WIll be measured with a digital caliper at baseline and 4 months.

  Baseline and 4 months

Secondary Outcomes (1)

• Histologic Healing of the Osseous Graft

  4 months

Study Arms (2)

Intrasocket graft

ACTIVE COMPARATOR

Positive control

Procedure: Intrasocket graft

Intrasocket plus facial overlay graft

EXPERIMENTAL

Intrasocket cancellous allograft plus a facial overlay bovine xenograft

Procedure: Intrasocket plus facial overlay graft

Interventions

Intrasocket graft PROCEDURE

Intrasocket mineralized cancellous allograft

Intrasocket graft

Intrasocket plus facial overlay graft PROCEDURE

Intrasocket mineralized cancellous allograft plus a facial overlay graft of bovine xenograft

Intrasocket plus facial overlay graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Healthy person that is at least 18 years old.
• Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.

You may not qualify if:

• Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.
• Molar teeth.
• Presence of or history of osteonecrosis of the jaws.
• Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of the duration.
• Patients who have been treated with oral bisphosphonates for more than three years.
• Pregnant women due to the possibility of miscarriage.
• Patients with an allergy to any material or medication used in the study.
• Patients who need prophylactic antibiotics.
• Previous head and neck radiation therapy.
• Chemotherapy in the previous 12 months.
• Patients on long term NSAID or steroid therapy.

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

Graduate Periodontics Clinic, School of Dentistry, University of Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Bone Resorption

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Limitations and Caveats

There were no adverse events. 1 patient in the Intrasocket plus facial overlay graft group was excluded as an outlier. There was a large amount of bone gain and this skewed the data.

Results Point of Contact

• Title: Dr. Henry Greenwell, Principal Investigator
• Organization: University of Louisville

henry.greenwell@louisville.edu

502-852-6928

Study Officials

• Henry Greenwell, DMD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 7, 2011
• First Posted: September 9, 2011
• Study Start: September 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: January 31, 2017
• Results First Posted: January 31, 2017

Record last verified: 2016-12

Locations

US (1)