Comparison of Two Different Alveolar Ridge Preservation Techniques
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Alveolar Ridge Width
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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))
- Post-operative pain perception(1 week after surgical extraction procedure)
- Platform size of implant placed(Implant surgery, approximtely 4 months after baseline)
- 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))
- Elian classification (actual)(intra-operative surgical finding (extraction surgery)(time=0))
- Buccal plate fenestration(intra-operative surgical finding (extraction surgery)(time = 0))
- Peri-operative clinician's report (extraction difficulty)(intra-operative surgical finding (extraction surgery))
- Complications after surgery (infection)(0-4 months)
- Complications after surgery (membrane exfoliation)(0-4 months)
Investigators
Brandon Coleman
Assistant Director, Advanced Education Program in Periodontics
Eisenhower Army Medical Center