Comparison of Two Different Alveolar Ridge Preservation Techniques

February 6, 2017 updated by: Brandon Coleman, Eisenhower Army Medical Center
The purpose of this study is to compare two barrier membrane products, Cytoplast (dPTFE) and BioXclude (human amnion chorion allograft), for their relative efficacies in dental socket preservation procedures, both when the socket is filled and overfilled with freeze dried bone allograft (FDBA).

Study Overview

Status

Status

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

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

This single-blind, randomized clinical trial aims to compare two different, commercially available materials to assess their relative efficacies in socket preservation procedures after tooth extraction. Patients presenting with single teeth deemed clinically hopeless and treatment planned for removal in the normal course of clinical dentistry will be considered for this study. If eligible, a ridge/socket preservation procedure will be performed at the time of extraction. Periodontics residents will perform the procedure under the supervision of board certified staff. Patients will be randomized via concealed random number sequence into one of four groups, based on a combination of materials and graft placement techniques. Patients will be equally distributed into the following groups: (1) dense polytetrafluoroethylene (Cytoplast) (2) Cytoplast with additional buccal augmentation/onlay graft, (3) human amniotic-tissue derived membrane (BioXclude), and (4) BioXclude with additional buccal augmentation/onlay graft. All four treatment groups are consistent with the current standard of care, and this study seeks to compare techniques and materials as part of routine, clinical/periodontal therapy in order to determine superiority. Approximately 150 patients will be enrolled and distributed equally among the four groups. Any post-operative complications will be managed and documented during follow-up appointments at 1, 2 and 4 weeks. Cone beam computed tomography (CBCT) will be used as the primary assessment tool, and scans will be compared between a pre-operative baseline time point and a scan taken after 4 months of healing to prepare for implant placement. The primary dependent variables will be (1) percent of baseline alveolar ridge changes (both horizontal and vertical) and (2) whether or not the anticipated dental implant could be placed appropriately. Secondary outcomes include ease of use, perceptions of pain, complications, cost-effectiveness, and changes in keratinized tissue.

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 (Anticipated)

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.
150

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
    • Georgia
      • Fort Gordon, Georgia, United States, 30905
        • Tingay Dental Clinic

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

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All active duty military patients (age 18-65) referred to the investigators' facility's periodontics department for diagnosis of "hopeless" tooth with documented confirmation of diagnosis by periodontal staff
  • Eligible for extraction and ridge preservation (adequately healthy and not otherwise disqualified)

Exclusion Criteria:

  • Pregnant or breastfeeding
  • History of allergy to involved products
  • Current acute infection at the site (chronic periapical infections will not exclude the patient)
  • Elian Type 3 extraction sockets
  • Sites not treatment planned for implant therapy
  • Third molar sites
  • American Society of Anesthesiology Category III patients (medically compromised)
  • Active duty military patients in a student status

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

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: Cytoplast
Patients will receive ridge preservation procedure with a Cytoplast barrier membrane
Device: dense polytetrafluoroethylene (dPTFE) membrane Cytoplast
ridge preservation intervention using the dPTFE membrane device
Other Names:
  • Cytoplast
Procedure: Ridge Preservation with overlay graft
ridge preservation intervention with additional freeze dried bone allograft (FDBA) placed buccal to the socket
Procedure: Ridge Preservation without overlay graft
ridge preservation without overlay graft / traditional FDBA placement into the socket only
EXPERIMENTAL: BioXclude
Patients will receive ridge preservation procedure with a BioXclude barrier membrane
Procedure: Ridge Preservation with overlay graft
ridge preservation intervention with additional freeze dried bone allograft (FDBA) placed buccal to the socket
Procedure: Ridge Preservation without overlay graft
ridge preservation without overlay graft / traditional FDBA placement into the socket only
Device: human amniotic-tissue derived membrane BioXclude
ridge preservation intervention using the dPTFE membrane device
Other Names:
  • BioXclude

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
Measure Description
Time Frame
Alveolar Ridge Width
Time Frame: from baseline to final cone beam CT scan (approximately 4 months)
Alveolar ridge dimensional change (horizontal) from Cone beam CT
from baseline to final cone beam CT scan (approximately 4 months)
Alveolar Ridge Height
Time Frame: from baseline to final cone beam CT scan (approximately 4 months)
Alveolar ridge dimensional change (vertical) from cone beam CT
from baseline to final cone beam CT scan (approximately 4 months)

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
Post-operative pain perception
Time Frame: 1 week after surgical extraction procedure
self-report by patient on visual analog scale
1 week after surgical extraction procedure
Platform size of implant placed
Time Frame: Implant surgery, approximtely 4 months after baseline
Whether or not the originally intended implant size could be placed
Implant surgery, approximtely 4 months after baseline
Keratinized tissue width (baseline)
Time Frame: pre-op / baseline assessment (after randomization)(prior to time=0)
pre-op / baseline assessment (after randomization)(prior to time=0)
Keratinized tissue width (final)
Time Frame: from pre-op assessment at time of randomization to implant surgery (4 months)
from pre-op assessment at time of randomization to implant surgery (4 months)
Elian classification (anticipated)
Time Frame: pre-op / baseline assessment (after randomization)(prior to time=0)
Operators will report an anticipated socket preservation classification according to Elian 2007
pre-op / baseline assessment (after randomization)(prior to time=0)
Elian classification (actual)
Time Frame: intra-operative surgical finding (extraction surgery)(time=0)
Operators will report the actual socket preservation classification according to Elian 2007
intra-operative surgical finding (extraction surgery)(time=0)
Buccal plate thickness
Time Frame: intra-operative surgical finding (extraction surgery)(time = 0)
intra-operative measurements, presence or absence of a dehiscence / fenestration
intra-operative surgical finding (extraction surgery)(time = 0)
Buccal plate fenestration
Time Frame: intra-operative surgical finding (extraction surgery)(time = 0)
determined at time of extraction surgery, and noted as a possible confounding variable
intra-operative surgical finding (extraction surgery)(time = 0)
Complications after surgery (infection)
Time Frame: 0-4 months
infection, determined by presence of purulence, lymphadenopathy and/or febrile status
0-4 months
Complications after surgery (membrane exfoliation)
Time Frame: 0-4 months
dichotomous variable, presence or absence of the membrane for the duration of the study
0-4 months
Peri-operative clinician's report (extraction difficulty)
Time Frame: intra-operative surgical finding (extraction surgery)
subjective extraction difficulty, as reported by the clinician
intra-operative surgical finding (extraction surgery)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sedation utilization
Time Frame: intra-operative surgical variable (determined in advance, at baseline)
presence or absence of sedation drugs during the procedure
intra-operative surgical variable (determined in advance, at baseline)
Cost
Time Frame: 0-4 months
cost/benefit for each product
0-4 months

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.
Eisenhower Army Medical Center

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: Brandon Coleman, DDS,MS, US Army Fort Gordon DENTAC

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.
July 1, 2015

Primary Completion (ANTICIPATED)

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.
July 1, 2018

Study Completion (ANTICIPATED)

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.
July 1, 2018

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).
June 19, 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.
June 25, 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.
June 26, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

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.
February 7, 2017

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.
February 6, 2017

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.
February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • 408953-1

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