Evaluation of Zimmer Puros® Allograft vs. Creos™ Allograft for Alveolar Ridge Preservation

NCT02444052 | Completed

• 1 other identifier: IRB20150016
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate clinically, histologically and radiographically the healing of extraction sockets with Zimmer's Puros® allograft compared to creos™ (creo™ Nobel Biocare,), a low-cost allograft material, 90 days following exodontia.

Conditions

Alveolar Bone Grafting; Allograft; Dental Extraction; Dental Implant; Socket Preservation

Outcome Measures

Primary Outcomes (5)

• Bone change in millimeters from initial (baseline) to full healing (week 12)

  At week 12

• Cone beam computed tomography bone density changes

  At week 12

• Percentage of bone formation in the alveolar bone core biopsies

  At week 12

• Percentage of volumetric bone formation observed by comparison of Cone beam computed tomography images and the percentage of residual Puros® bone cores

  At week 12

• Percentage of volumetric bone formation observed by comparison of Cone beam computed tomography images and the percentage of residual creos™ allograft in the bone cores

  At week 12

Secondary Outcomes (5)

• Facial/buccal alveolar bone thickness measured in millimeters with calipers

  At Baseline

• Length of alveolar dehiscence defects measured in millimeters with a periodontal probe

  At Baseline

• Width of alveolar dehiscence defects measured in millimeters with a periodontal probe

  At Baseline

• Plaque score

  Pre-op, Baseline, Week 2, 8 and 12

• Subjective clinical bone density on re-entry

  At week 12

Study Arms (2)

Zimmer Puros Cancellous Allograft

EXPERIMENTAL

Right side will have an extraction followed by an allogenic bone graft zimmer puros followed by implant placement.

Device: Zimmer Puros Cancellous Allograft

Nobel Biocare Creos Cancellous Allograft

EXPERIMENTAL

Left side will have an extraction followed by an allogenic bone nobel biocare creos graft followed by implant placement.

Device: Nobel Biocare Creos Cancellous Allograft

Interventions

Zimmer Puros Cancellous Allograft DEVICE

Right side will have an extraction followed by an allogenic bone graft zimmer puros followed by implant placement.

Zimmer Puros Cancellous Allograft

Nobel Biocare Creos Cancellous Allograft DEVICE

Left side will have an extraction followed by an allogenic bone nobel biocare creos graft followed by implant placement.

Nobel Biocare Creos Cancellous Allograft

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemically healthy subjects with two non-adjacent molar or premolar teeth located in the same jaw that require extraction and socket augmentation for implant site development (treatment sites may be located in either the mandibular or maxillary jaw)
• Residual extraction sockets must have \<70% bone loss in all dimensions (3 or 4-walled bony defects)
• Nonsmokers (individuals who quit smoking at least 6 months prior to the study will be allowed to participate)
• Subjects willing and able to comply with all study-related procedures including maintenance of good oral hygiene and compliance with re-evaluation appointments
• Subjects who read, understand and are willing to sign an informed consent statement.

You may not qualify if:

• Inadequate zone of keratinized gingiva (KG) or alveolar mucosa to obtain primary wound closure of the surgical site
• Presence of acute infections at the time of tooth extraction
• Clinically significant or unstable (as defined by the investigators) systemic diseases affecting bone or soft tissue growth; or other renal, hepatic, cardiac, endocrine, hematologic, autoimmune or acute infectious diseases that makes interpretation of the data more difficult
• History of head \& neck radiation therapy
• Subjects taking steroids, tetracycline or tetracycline analogs, bone therapeutic levels of fluorides, biphosphonates, medications affecting bone turnover, antibiotics for \>7 days or any investigational drug
• Patients who are or become pregnant during the length of the study.

Sponsors & Collaborators

• University of Florida: lead
• Zimmer Biomet: collaborator

Study Sites (1)

University of Florida College of Dentistry-Periodontics

Gainesville, Florida, 32610, United States

Location

Study Officials

• Rodrigo Neiva, DDS,MS

  Program Director Grad Perio UFCD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2015
• First Posted: May 14, 2015
• Study Start: October 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: October 1, 2017
• Last Updated: April 2, 2018

Record last verified: 2018-03

Locations

US (1)