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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

Tracking Information
First Submitted Date  ICMJE June 19, 2015
First Posted Date  ICMJE June 26, 2015
Last Update Posted Date February 7, 2017
Study Start Date  ICMJE July 2015
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2015)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02482987 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2015)
  • Post-operative pain perception [ Time Frame: 1 week after surgical extraction procedure ]
    self-report by patient on visual analog scale
  • 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
  • Keratinized tissue width (baseline) [ Time Frame: 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) ]
  • 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
  • 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
  • Buccal plate thickness [ Time Frame: intra-operative surgical finding (extraction surgery)(time = 0) ]
    intra-operative measurements, presence or absence of a dehiscence / fenestration
  • 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
  • Complications after surgery (infection) [ Time Frame: 0-4 months ]
    infection, determined by presence of purulence, lymphadenopathy and/or febrile status
  • Complications after surgery (membrane exfoliation) [ Time Frame: 0-4 months ]
    dichotomous variable, presence or absence of the membrane for the duration of the study
  • Peri-operative clinician's report (extraction difficulty) [ Time Frame: intra-operative surgical finding (extraction surgery) ]
    subjective extraction difficulty, as reported by the clinician
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 25, 2015)
  • Sedation utilization [ Time Frame: intra-operative surgical variable (determined in advance, at baseline) ]
    presence or absence of sedation drugs during the procedure
  • Cost [ Time Frame: 0-4 months ]
    cost/benefit for each product
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Comparison of Two Different Alveolar Ridge Preservation Techniques
Official Title  ICMJE Comparison of Two Different Alveolar Ridge Preservation Techniques
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).
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Loss of Teeth Due to Extraction
Intervention  ICMJE
  • Device: dense polytetrafluoroethylene (dPTFE) membrane Cytoplast
    ridge preservation intervention using the dPTFE membrane device
    Other Name: Cytoplast
  • 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
Study Arms  ICMJE
  • Experimental: Cytoplast
    Patients will receive ridge preservation procedure with a Cytoplast barrier membrane
    Interventions:
    • Device: dense polytetrafluoroethylene (dPTFE) membrane Cytoplast
    • Procedure: Ridge Preservation with overlay graft
    • Procedure: Ridge Preservation without overlay graft
  • Experimental: BioXclude
    Patients will receive ridge preservation procedure with a BioXclude barrier membrane
    Interventions:
    • Device: human amniotic-tissue derived membrane BioXclude
    • Procedure: Ridge Preservation with overlay graft
    • Procedure: Ridge Preservation without overlay graft
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 25, 2015)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2018
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02482987
Other Study ID Numbers  ICMJE 408953-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Brandon Coleman, Eisenhower Army Medical Center
Study Sponsor  ICMJE Eisenhower Army Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Brandon Coleman, DDS,MS US Army Fort Gordon DENTAC
PRS Account Eisenhower Army Medical Center
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP