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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cytoplast | Experimental | Patients will receive ridge preservation procedure with a Cytoplast barrier membrane |
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| BioXclude | Experimental | Patients will receive ridge preservation procedure with a BioXclude barrier membrane |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dense polytetrafluoroethylene (dPTFE) membrane Cytoplast | Device | ridge preservation intervention using the dPTFE membrane device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative pain perception | self-report by patient on visual analog scale | 1 week after surgical extraction procedure |
| Platform size of implant placed | Whether or not the originally intended implant size could be placed |
| Measure | Description | Time Frame |
|---|---|---|
| Sedation utilization | presence or absence of sedation drugs during the procedure | intra-operative surgical variable (determined in advance, at baseline) |
| Cost | cost/benefit for each product |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brandon Coleman, DDS,MS | US Army Fort Gordon DENTAC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tingay Dental Clinic | Fort Gordon | Georgia | 30905 | United States |
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| human amniotic-tissue derived membrane BioXclude | Device | ridge preservation intervention using the dPTFE membrane device |
|
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| Ridge Preservation with overlay graft | Procedure | ridge preservation intervention with additional freeze dried bone allograft (FDBA) placed buccal to the socket |
|
| Ridge Preservation without overlay graft | Procedure | ridge preservation without overlay graft / traditional FDBA placement into the socket only |
|
| 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) | 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) | Operators will report the actual socket preservation classification according to Elian 2007 | intra-operative surgical finding (extraction surgery)(time=0) |
| Buccal plate thickness | intra-operative measurements, presence or absence of a dehiscence / fenestration | intra-operative surgical finding (extraction surgery)(time = 0) |
| Buccal plate fenestration | 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) | infection, determined by presence of purulence, lymphadenopathy and/or febrile status | 0-4 months |
| Complications after surgery (membrane exfoliation) | dichotomous variable, presence or absence of the membrane for the duration of the study | 0-4 months |
| Peri-operative clinician's report (extraction difficulty) | subjective extraction difficulty, as reported by the clinician | intra-operative surgical finding (extraction surgery) |
| 0-4 months |