Loss of Teeth Due to Extraction
Conditions
Keywords
dental, extraction, socket preservation, ridge preservation, implant site preparation
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.
Interventions
DEVICEdense polytetrafluoroethylene (dPTFE) membrane Cytoplast
ridge preservation intervention using the dPTFE membrane device
DEVICEhuman amniotic-tissue derived membrane BioXclude
ridge preservation intervention using the dPTFE membrane device
PROCEDURERidge Preservation with overlay graft
ridge preservation intervention with additional freeze dried bone allograft (FDBA) placed buccal to the socket
PROCEDURERidge Preservation without overlay graft
ridge preservation without overlay graft / traditional FDBA placement into the socket only
Sponsors
Eisenhower Army Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
| Keratinized tissue width (final) | from pre-op assessment at time of randomization to implant surgery (4 months) | — |
| 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 |
| Buccal plate thickness | intra-operative surgical finding (extraction surgery)(time = 0) | intra-operative measurements, presence or absence of a dehiscence / fenestration |
| Buccal plate fenestration | 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) | 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 |
| Peri-operative clinician's report (extraction difficulty) | intra-operative surgical finding (extraction surgery) | subjective extraction difficulty, as reported by the clinician |
| Elian classification (actual) | intra-operative surgical finding (extraction surgery)(time=0) | Operators will report the actual socket preservation classification according to Elian 2007 |
| Post-operative pain perception | 1 week after surgical extraction procedure | self-report by patient on visual analog scale |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sedation utilization | intra-operative surgical variable (determined in advance, at baseline) | presence or absence of sedation drugs during the procedure |
| Cost | 0-4 months | cost/benefit for each product |
Countries
United States
Outcome results
None listed