NCT02482987

Brief Summary

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 26, 2015

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

3 years

First QC Date

June 19, 2015

Last Update Submit

February 6, 2017

Conditions

Loss of Teeth Due to Extraction

Keywords

dentalextractionsocket preservationridge preservationimplant site preparation

Outcome Measures

Primary Outcomes (2)

  • Alveolar Ridge Width

    Alveolar ridge dimensional change (horizontal) from Cone beam CT

    from baseline to final cone beam CT scan (approximately 4 months)

  • Alveolar Ridge Height

    Alveolar ridge dimensional change (vertical) from cone beam CT

    from baseline to final cone beam CT scan (approximately 4 months)

Secondary Outcomes (11)

  • Post-operative pain perception

    1 week after surgical extraction procedure

  • Platform size of implant placed

    Implant surgery, approximtely 4 months after baseline

  • Keratinized tissue width (baseline)

    pre-op / baseline assessment (after randomization)(prior to time=0)

  • Keratinized tissue width (final)

    from pre-op assessment at time of randomization to implant surgery (4 months)

  • Elian classification (anticipated)

    pre-op / baseline assessment (after randomization)(prior to time=0)

  • +6 more secondary outcomes

Other Outcomes (2)

  • Sedation utilization

    intra-operative surgical variable (determined in advance, at baseline)

  • Cost

    0-4 months

Study Arms (2)

Cytoplast

EXPERIMENTAL

Patients will receive ridge preservation procedure with a Cytoplast barrier membrane

Device: dense polytetrafluoroethylene (dPTFE) membrane CytoplastProcedure: Ridge Preservation with overlay graftProcedure: Ridge Preservation without overlay graft

BioXclude

EXPERIMENTAL

Patients will receive ridge preservation procedure with a BioXclude barrier membrane

Device: human amniotic-tissue derived membrane BioXcludeProcedure: Ridge Preservation with overlay graftProcedure: Ridge Preservation without overlay graft

Interventions

dense polytetrafluoroethylene (dPTFE) membrane CytoplastDEVICE

ridge preservation intervention using the dPTFE membrane device

Also known as: Cytoplast
Cytoplast
human amniotic-tissue derived membrane BioXcludeDEVICE

ridge preservation intervention using the dPTFE membrane device

Also known as: BioXclude
BioXclude
Ridge Preservation with overlay graftPROCEDURE

ridge preservation intervention with additional freeze dried bone allograft (FDBA) placed buccal to the socket

BioXcludeCytoplast
Ridge Preservation without overlay graftPROCEDURE

ridge preservation without overlay graft / traditional FDBA placement into the socket only

BioXcludeCytoplast

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tingay Dental Clinic

Fort Gordon, Georgia, 30905, United States

Location

Study Officials

  • Brandon Coleman, DDS,MS

    US Army Fort Gordon DENTAC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Director, Advanced Education Program in Periodontics

Study Record Dates

First Submitted

June 19, 2015

First Posted

June 26, 2015

Study Start

July 1, 2015

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

February 7, 2017

Record last verified: 2017-02

Locations

US(1)