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.
- 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
- Pregnant or breastfeeding
- History of allergy to involved products
- Current acute infection at the site (chronic periapical infections will not exclude
- 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