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

March 30, 2018 updated by: University of Florida

Clinical and Histological Evaluation of Zimmer Puros® Allograft vs. Creos™ (Low-cost) Allograft for Alveolar Ridge Preservation Following Exodontia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Twenty-four consecutive subjects requiring extraction of two non-adjacent molars or premolars located in the same jaw will be selected from the patient pool of the Center for Advanced Periodontology at the University of Florida, College of Dentistry.

Preoperative Procedures: At the initial screening, the goals of the study, potential risks and possible benefits will be explained and each subject will be asked to sign a written consent statement permitting extraction of the involved teeth and the placement of Puros® allograft and creos™ allograft for ridge preservation. After which a complete medical and dental history will be obtained, a pregnancy test will be performed, and establishment of inclusion and exclusion criteria will be determined. If meeting all study criteria, examination periapical radiographs will be taken and each subject will receive oral hygiene instructions, prophylaxis, and full-arch alginate impressions. The study models will also be used to fabricate occlusal templates to permit reproducible clinical measurements of the alveolar ridge dimensions of the residual tooth socket.

Surgical Protocol & Treatment Assessment: To help minimize technical variances in the surgical treatment protocol, the primary investigator will perform baseline and 12-week re-entry surgeries. Under local anesthesia, full-thickness mucoperiosteal flaps will be elevated; the selected teeth will be extracted atraumatically, followed by debridement of the sockets, and collection of all clinical measurements.The following clinical measurements will be made at the baseline and re-entry surgeries using standard University of North Carolina (UNC) manual probes (Hu-Friedy, Chicago, IL):

  1. Facial/buccal thickness (baseline, only)
  2. Distance from the occlusal template to the facial, lingual and crestal bone
  3. Socket depth (or template to crest distance at the 90-day re-entry surgery)
  4. Osseous dehiscence location and dimension
  5. Bone density (on re-entry)

The surgeon will then preserve each site with either Puros® allograft creos™ allograft. Puros® allograft will be placed into half of the extraction sockets to the level of the osseous crest. A bovine pericardium membrane (CopiOs ®Pericardium) will be then placed to cover the bone graft material. Primary closure will be achieved in all cases. The site will be sutured with 4.0 PTFE sutures. The other extraction sites will receive the same treatment but with creos™ allograft. Participants will be prescribed a 10 day regimen of Ibuprofen (2.4g/day) and antibiotics (amoxicillin (1.5g/day) or clindamycin (0.6g/day)) unless other allergies are present. Subjects will be instructed to change their diet to semi-liquid for 48 hours, followed by soft foods for the first 2-weeks. Subjects will also be instructed to begin rinsing with warm water, as needed, and to resume their normal oral hygiene routine the day after surgery in all areas except the surgical site.

At 2-week post-surgery, the extraction sites will be inspected and gently cleaned with saline-soaked gauze, health histories will be reviewed, oral hygiene instructions will be repeated, photographs will be taken; and a plaque score will be recorded. Cone beam CT images will be performed 2 weeks and 12 weeks post-operative. All imaging will be done using the Kodak limited view CBCT to minimize the subjects' exposure to radiation.

Soft tissue healing will be assessed at 2, 8 and 12 weeks with a wound-healing index (WHI) according to the following scheme: score "1" for uneventful wound healing with no gingival edema, erythema, suppuration, discomfort or graft exposure; score "2" for uneventful wound healing with slight gingival edema, erythema, or discomfort, but minimal loss of graft and no suppuration; score "3" for poor wound healing with significant gingival edema, erythema, discomfort, loss of graft or any suppuration.

Re-entry surgery will be performed at 12 weeks, and all clinical measurements will be repeated. Crestal flapless soft tissue and bone core biopsies approximately 2.7 x 10 mm in size will be removed with a 3.2 mm trephine drill from the area corresponding to the center of the previous extraction from the crest of the ridge using the occlusal template as a guide.

The cores will be placed in bottles of 10% neutral buffered formalin (NBF) for fixation, and then labeled with a 5-digit number in order to permit masked histomorphometric analysis. Analysis will be performed in the outer aspect of the bone cores, which correspond to the bone surface that will contact the dental implants at the time of placement. Zimmer TSTV implants will be placed at the same time the second re-entry procedure is done. All implants will be placed according to the manufacturer's specifications. Restorative treatment will be initiated 90 days after implant placement.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida College of Dentistry-Periodontics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Zimmer Puros Cancellous Allograft
Right side will have an extraction followed by an allogenic bone graft zimmer puros followed by implant placement.
Device: Zimmer Puros Cancellous Allograft
Right side will have an extraction followed by an allogenic bone graft zimmer puros followed by implant placement.
Experimental: Nobel Biocare Creos Cancellous Allograft
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
Left side will have an extraction followed by an allogenic bone nobel biocare creos graft followed by implant placement.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Bone change in millimeters from initial (baseline) to full healing (week 12)
Time Frame: At week 12
At week 12
Cone beam computed tomography bone density changes
Time Frame: At week 12
At week 12
Percentage of bone formation in the alveolar bone core biopsies
Time Frame: At week 12
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
Time Frame: At week 12
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
Time Frame: At week 12
At week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Facial/buccal alveolar bone thickness measured in millimeters with calipers
Time Frame: At Baseline
After extraction of the tooth, the facial/buccal bone thickness will be measured with calipers to the nearest millimeter.
At Baseline
Length of alveolar dehiscence defects measured in millimeters with a periodontal probe
Time Frame: At Baseline
This measurement is made after the tooth is extracted and measured with a periodontal probe to the nearest millimeter
At Baseline
Width of alveolar dehiscence defects measured in millimeters with a periodontal probe
Time Frame: At Baseline
This measurement is made after the tooth is extracted and measured with a periodontal probe to the nearest millimeter
At Baseline
Plaque score
Time Frame: Pre-op, Baseline, Week 2, 8 and 12
A disclosing solution such is painted on all exposed tooth surfaces. After the patient has rinsed, the operator (using an explorer or a tip of a probe) examines each stained surface for soft accumulations at the dentogingival junction. When found, they are recorded by making a dash/red color in the appropriate spaces on the record form. Those surfaces, which do not have soft accumulations at the dentogingival junction, are not recorded.
Pre-op, Baseline, Week 2, 8 and 12
Subjective clinical bone density on re-entry
Time Frame: At week 12
Assessed during osteotomy for implant placement
At week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florida

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Zimmer Biomet

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rodrigo Neiva, DDS,MS, Program Director Grad Perio UFCD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 14, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB20150016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dental Implant

Clinical Trials on Zimmer Puros Cancellous Allograft

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings