Comparison of Two Different Alveolar Ridge Preservation Techniques
- Conditions
- Loss of Teeth Due to Extraction
- Interventions
- Device: dense polytetrafluoroethylene (dPTFE) membrane CytoplastDevice: human amniotic-tissue derived membrane BioXcludeProcedure: Ridge Preservation with overlay graftProcedure: Ridge Preservation without overlay graft
- Registration Number
- NCT02482987
- Lead Sponsor
- 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).
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
- 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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cytoplast Ridge Preservation with overlay graft Patients will receive ridge preservation procedure with a Cytoplast barrier membrane Cytoplast dense polytetrafluoroethylene (dPTFE) membrane Cytoplast Patients will receive ridge preservation procedure with a Cytoplast barrier membrane Cytoplast Ridge Preservation without overlay graft Patients will receive ridge preservation procedure with a Cytoplast barrier membrane BioXclude human amniotic-tissue derived membrane BioXclude Patients will receive ridge preservation procedure with a BioXclude barrier membrane BioXclude Ridge Preservation with overlay graft Patients will receive ridge preservation procedure with a BioXclude barrier membrane BioXclude Ridge Preservation without overlay graft Patients will receive ridge preservation procedure with a BioXclude barrier membrane
- Primary Outcome Measures
Name Time Method Alveolar Ridge Width from baseline to final cone beam CT scan (approximately 4 months) Alveolar ridge dimensional change (horizontal) from Cone beam CT
Alveolar Ridge Height from baseline to final cone beam CT scan (approximately 4 months) Alveolar ridge dimensional change (vertical) from cone beam CT
- Secondary Outcome Measures
Name Time Method Keratinized tissue width (final) from pre-op assessment at time of randomization to implant surgery (4 months) Buccal plate thickness intra-operative surgical finding (extraction surgery)(time = 0) intra-operative measurements, presence or absence of a dehiscence / fenestration
Post-operative pain perception 1 week after surgical extraction procedure self-report by patient on visual analog scale
Platform size of implant placed Implant surgery, approximtely 4 months after baseline Whether or not the originally intended implant size could be placed
Keratinized tissue width (baseline) pre-op / baseline assessment (after randomization)(prior to time=0) Elian classification (anticipated) 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) intra-operative surgical finding (extraction surgery)(time=0) Operators will report the actual socket preservation classification according to Elian 2007
Buccal plate fenestration intra-operative surgical finding (extraction surgery)(time = 0) determined at time of extraction surgery, and noted as a possible confounding variable
Peri-operative clinician's report (extraction difficulty) intra-operative surgical finding (extraction surgery) subjective extraction difficulty, as reported by the clinician
Complications after surgery (infection) 0-4 months infection, determined by presence of purulence, lymphadenopathy and/or febrile status
Complications after surgery (membrane exfoliation) 0-4 months dichotomous variable, presence or absence of the membrane for the duration of the study
Trial Locations
- Locations (1)
Tingay Dental Clinic
🇺🇸Fort Gordon, Georgia, United States