Comparison of Two Different Alveolar Ridge Preservation Techniques

NCT ID: NCT02482987

Last Updated: 2017-02-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2018-07-31

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.

Conditions

Loss of Teeth Due to Extraction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cytoplast

Patients will receive ridge preservation procedure with a Cytoplast barrier membrane

Group Type: EXPERIMENTAL

dense polytetrafluoroethylene (dPTFE) membrane Cytoplast

Intervention Type: DEVICE

ridge preservation intervention using the dPTFE membrane device

Ridge Preservation with overlay graft

Intervention Type: PROCEDURE

ridge preservation intervention with additional freeze dried bone allograft (FDBA) placed buccal to the socket

Ridge Preservation without overlay graft

Intervention Type: PROCEDURE

ridge preservation without overlay graft / traditional FDBA placement into the socket only

BioXclude

Patients will receive ridge preservation procedure with a BioXclude barrier membrane

Group Type: EXPERIMENTAL

human amniotic-tissue derived membrane BioXclude

Intervention Type: DEVICE

ridge preservation intervention using the dPTFE membrane device

Ridge Preservation with overlay graft

Intervention Type: PROCEDURE

ridge preservation intervention with additional freeze dried bone allograft (FDBA) placed buccal to the socket

Ridge Preservation without overlay graft

Intervention Type: PROCEDURE

ridge preservation without overlay graft / traditional FDBA placement into the socket only

Interventions

dense polytetrafluoroethylene (dPTFE) membrane Cytoplast

ridge preservation intervention using the dPTFE membrane device

Intervention Type: DEVICE

human amniotic-tissue derived membrane BioXclude

ridge preservation intervention using the dPTFE membrane device

Intervention Type: DEVICE

Ridge Preservation with overlay graft

ridge preservation intervention with additional freeze dried bone allograft (FDBA) placed buccal to the socket

Intervention Type: PROCEDURE

Ridge Preservation without overlay graft

ridge preservation without overlay graft / traditional FDBA placement into the socket only

Intervention Type: PROCEDURE

Other Intervention Names

Cytoplast; BioXclude

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisenhower Army Medical Center

FED

Sponsor Role: lead

Responsible Party

Brandon Coleman

Assistant Director, Advanced Education Program in Periodontics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brandon Coleman, DDS,MS

Role: PRINCIPAL_INVESTIGATOR

US Army Fort Gordon DENTAC

Locations

Tingay Dental Clinic

Fort Gordon, Georgia, United States

Countries

United States

Other Identifiers

408953-1

Identifier Type: -

Identifier Source: org_study_id