Comparison of Two Different Alveolar Ridge Preservation Techniques

Eisenhower Army Medical Center

Status: Unknown

Conditions: Loss of Teeth Due to Extraction

Treatments: Device: human amniotic-tissue derived membrane BioXclude; Procedure: Ridge Preservation without overlay graft; Procedure: Ridge Preservation with overlay graft; Device: dense polytetrafluoroethylene (dPTFE) membrane Cytoplast

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02482987

408953-1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

Cytoplast

Experimental group

Description:

Patients will receive ridge preservation procedure with a Cytoplast barrier membrane

Treatment:

Procedure: Ridge Preservation without overlay graft

Procedure: Ridge Preservation with overlay graft

Device: dense polytetrafluoroethylene (dPTFE) membrane Cytoplast

BioXclude

Experimental group

Description:

Patients will receive ridge preservation procedure with a BioXclude barrier membrane

Treatment:

Procedure: Ridge Preservation without overlay graft

Procedure: Ridge Preservation with overlay graft

Device: human amniotic-tissue derived membrane BioXclude