Comparison of Two Different Alveolar Ridge Preservation Techniques

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Comparison of Two Different Alveolar Ridge Preservation Techniques

Conditions
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Loss of Teeth Due to Extraction

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cytoplast<br>Patients will receive ridge preservation procedure with a Cytoplast barrier membrane | Device: dense polytetrafluoroethylene (dPTFE) membrane Cytoplast<br>* ridge preservation intervention using the dPTFE membrane device<br>* Other names: Cytoplast;Procedure: Ridge Preservation with overlay graft<br>* ridge preservation intervention with additional freeze dried bone allograft (FDBA) placed buccal to the socket<br>Procedure: Ridge Preservation without overlay graft<br>* ridge preservation without overlay graft / traditional FDBA placement into the socket only<br>|
| Experimental: BioXclude<br>Patients will receive ridge preservation procedure with a BioXclude barrier membrane | Device: human amniotic-tissue derived membrane BioXclude<br>* ridge preservation intervention using the dPTFE membrane device<br>* Other names: BioXclude;Procedure: Ridge Preservation with overlay graft<br>* ridge preservation intervention with additional freeze dried bone allograft (FDBA) placed buccal to the socket<br>Procedure: Ridge Preservation without overlay graft<br>* ridge preservation without overlay graft / traditional FDBA placement into the socket only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental, extraction, socket preservation, ridge preservation, implant site preparation