Clinical trial NCT02482987: Comparison of Two Different Alveolar Ridge Preservation Techniques
Official title: Comparison of Two Different Alveolar Ridge Preservation Techniques
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Loss of Teeth Due to Extraction
Keywords: dental
extraction
socket preservation
ridge preservation
implant site preparation
Lead sponsor: Eisenhower Army Medical Center
Sponsor class: FED
First posted: 2015-06-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Alveolar Ridge Width
timeFrame: from baseline to final cone beam CT scan (approximately 4 months)
measure: Alveolar Ridge Height
timeFrame: from baseline to final cone beam CT scan (approximately 4 months)
Secondary outcomes:
measure: Post-operative pain perception
timeFrame: 1 week after surgical extraction procedure
measure: Platform size of implant placed
timeFrame: Implant surgery, approximtely 4 months after baseline
measure: Keratinized tissue width (baseline)
timeFrame: pre-op / baseline assessment (after randomization)(prior to time=0)
measure: Keratinized tissue width (final)
timeFrame: from pre-op assessment at time of randomization to implant surgery (4 months)
measure: Elian classification (anticipated)
timeFrame: pre-op / baseline assessment (after randomization)(prior to time=0)
measure: Elian classification (actual)
timeFrame: intra-operative surgical finding (extraction surgery)(time=0)
measure: Buccal plate thickness
timeFrame: intra-operative surgical finding (extraction surgery)(time = 0)
measure: Buccal plate fenestration
timeFrame: intra-operative surgical finding (extraction surgery)(time = 0)
measure: Complications after surgery (infection)
timeFrame: 0-4 months
measure: Complications after surgery (membrane exfoliation)
timeFrame: 0-4 months
measure: Peri-operative clinician's report (extraction difficulty)
timeFrame: intra-operative surgical finding (extraction surgery)
Other outcomes:
measure: Sedation utilization
timeFrame: intra-operative surgical variable (determined in advance, at baseline)
measure: Cost
timeFrame: 0-4 months
Locations:
city: Fort Gordon
country: United States
facility: Tingay Dental Clinic
state: Georgia
Study officials:
affiliation: US Army Fort Gordon DENTAC
name: Brandon Coleman, DDS,MS
role: PRINCIPAL_INVESTIGATOR
References: