Comparison of Two Different Alveolar Ridge Preservation Techniques

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).

Study Overview

• Status: Unknown
• Conditions: Loss of Teeth Due to Extraction
• Intervention / Treatment: Device: dense polytetrafluoroethylene (dPTFE) membrane Cytoplast; Procedure: Ridge Preservation with overlay graft; Procedure: Ridge Preservation without overlay graft; Device: human amniotic-tissue derived membrane BioXclude

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Fort Gordon, Georgia, United States, 30905
      • Tingay Dental Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cytoplast; Patients will receive ridge preservation procedure with a Cytoplast barrier membrane	Device: dense polytetrafluoroethylene (dPTFE) membrane Cytoplast; ridge preservation intervention using the dPTFE membrane device; Other Names: Cytoplast; Procedure: Ridge Preservation with overlay graft; ridge preservation intervention with additional freeze dried bone allograft (FDBA) placed buccal to the socket; Procedure: Ridge Preservation without overlay graft; ridge preservation without overlay graft / traditional FDBA placement into the socket only
EXPERIMENTAL: BioXclude; Patients will receive ridge preservation procedure with a BioXclude barrier membrane	Procedure: Ridge Preservation with overlay graft; ridge preservation intervention with additional freeze dried bone allograft (FDBA) placed buccal to the socket; Procedure: Ridge Preservation without overlay graft; ridge preservation without overlay graft / traditional FDBA placement into the socket only; Device: human amniotic-tissue derived membrane BioXclude; ridge preservation intervention using the dPTFE membrane device; Other Names: BioXclude

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alveolar Ridge Width	Alveolar ridge dimensional change (horizontal) from Cone beam CT	from baseline to final cone beam CT scan (approximately 4 months)
Alveolar Ridge Height	Alveolar ridge dimensional change (vertical) from cone beam CT	from baseline to final cone beam CT scan (approximately 4 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative pain perception	self-report by patient on visual analog scale	1 week after surgical extraction procedure
Platform size of implant placed	Whether or not the originally intended implant size could be placed	Implant surgery, approximtely 4 months after baseline
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)	Operators will report an anticipated socket preservation classification according to Elian 2007	pre-op / baseline assessment (after randomization)(prior to time=0)
Elian classification (actual)	Operators will report the actual socket preservation classification according to Elian 2007	intra-operative surgical finding (extraction surgery)(time=0)
Buccal plate thickness	intra-operative measurements, presence or absence of a dehiscence / fenestration	intra-operative surgical finding (extraction surgery)(time = 0)
Buccal plate fenestration	determined at time of extraction surgery, and noted as a possible confounding variable	intra-operative surgical finding (extraction surgery)(time = 0)
Complications after surgery (infection)	infection, determined by presence of purulence, lymphadenopathy and/or febrile status	0-4 months
Complications after surgery (membrane exfoliation)	dichotomous variable, presence or absence of the membrane for the duration of the study	0-4 months
Peri-operative clinician's report (extraction difficulty)	subjective extraction difficulty, as reported by the clinician	intra-operative surgical finding (extraction surgery)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedation utilization	presence or absence of sedation drugs during the procedure	intra-operative surgical variable (determined in advance, at baseline)
Cost	cost/benefit for each product	0-4 months

Collaborators and Investigators

• Sponsor: Eisenhower Army Medical Center
• Investigators: Principal Investigator: Brandon Coleman, DDS,MS, US Army Fort Gordon DENTAC

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (ANTICIPATED): July 1, 2018
• Study Completion (ANTICIPATED): July 1, 2018

Study Registration Dates

• First Submitted: June 19, 2015
• First Submitted That Met QC Criteria: June 25, 2015
• First Posted (ESTIMATE): June 26, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): February 7, 2017
• Last Update Submitted That Met QC Criteria: February 6, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: dental; extraction; socket preservation; ridge preservation; implant site preparation
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Tooth Loss
• Other Study ID Numbers: 408953-1