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Comparison of Two Different Alveolar Ridge Preservation Techniques

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ClinicalTrials.gov Identifier: NCT02482987
Recruitment Status : Unknown
Verified February 2017 by Brandon Coleman, Eisenhower Army Medical Center.
Recruitment status was:  Enrolling by invitation
First Posted : June 26, 2015
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
Brandon Coleman, Eisenhower Army Medical Center

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).

Condition or disease Intervention/treatment Phase
Loss of Teeth Due to Extraction Device: dense polytetrafluoroethylene (dPTFE) membrane Cytoplast Device: human amniotic-tissue derived membrane BioXclude Procedure: Ridge Preservation with overlay graft Procedure: Ridge Preservation without overlay graft Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Two Different Alveolar Ridge Preservation Techniques
Study Start Date : July 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Arm Intervention/treatment
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 Name: 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
Device: human amniotic-tissue derived membrane BioXclude
ridge preservation intervention using the dPTFE membrane device
Other Name: BioXclude

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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Post-operative pain perception [ Time Frame: 1 week after surgical extraction procedure ]
    self-report by patient on visual analog scale

  2. 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

  3. Keratinized tissue width (baseline) [ Time Frame: pre-op / baseline assessment (after randomization)(prior to time=0) ]
  4. Keratinized tissue width (final) [ Time Frame: from pre-op assessment at time of randomization to implant surgery (4 months) ]
  5. 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

  6. 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

  7. Buccal plate thickness [ Time Frame: intra-operative surgical finding (extraction surgery)(time = 0) ]
    intra-operative measurements, presence or absence of a dehiscence / fenestration

  8. 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

  9. Complications after surgery (infection) [ Time Frame: 0-4 months ]
    infection, determined by presence of purulence, lymphadenopathy and/or febrile status

  10. Complications after surgery (membrane exfoliation) [ Time Frame: 0-4 months ]
    dichotomous variable, presence or absence of the membrane for the duration of the study

  11. Peri-operative clinician's report (extraction difficulty) [ Time Frame: intra-operative surgical finding (extraction surgery) ]
    subjective extraction difficulty, as reported by the clinician


Other Outcome Measures:
  1. Sedation utilization [ Time Frame: intra-operative surgical variable (determined in advance, at baseline) ]
    presence or absence of sedation drugs during the procedure

  2. Cost [ Time Frame: 0-4 months ]
    cost/benefit for each product



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02482987


Locations
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United States, Georgia
Tingay Dental Clinic
Fort Gordon, Georgia, United States, 30905
Sponsors and Collaborators
Eisenhower Army Medical Center
Investigators
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Principal Investigator: Brandon Coleman, DDS,MS US Army Fort Gordon DENTAC

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Responsible Party: Brandon Coleman, Assistant Director, Advanced Education Program in Periodontics, Eisenhower Army Medical Center
ClinicalTrials.gov Identifier: NCT02482987     History of Changes
Other Study ID Numbers: 408953-1
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017

Keywords provided by Brandon Coleman, Eisenhower Army Medical Center:
dental
extraction
socket preservation
ridge preservation
implant site preparation

Additional relevant MeSH terms:
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Tooth Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases