Loss of Teeth Due to ExtractionNCT02482987
Comparison of Two Different Alveolar Ridge Preservation Techniques
A study testing dense polytetrafluoroethylene (dPTFE) membrane Cytoplast, human amniotic-tissue derived membrane BioXclude and Ridge Preservation with overlay graft in people with Loss of Teeth Due to Extraction, run by Eisenhower Army Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Loss of Teeth Due to Extraction
- What is being tested?
- dense polytetrafluoroethylene (dPTFE) membrane Cytoplast, human amniotic-tissue derived membrane BioXclude and Ridge Preservation with overlay graft
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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).
Read the 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
- Being tested
- dense polytetrafluoroethylene (dPTFE) membrane Cytoplast, human amniotic-tissue derived membrane BioXclude, Ridge Preservation with overlay graft, Ridge Preservation without overlay graft
- Keywords
- dental, extraction, socket preservation, ridge preservation, implant site preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dense polytetrafluoroethylene (dPTFE) membrane CytoplastDevice
Also called Cytoplast
ridge preservation intervention using the dPTFE membrane device
human amniotic-tissue derived membrane BioXcludeDevice
Also called BioXclude
ridge preservation intervention using the dPTFE membrane device
Ridge Preservation with overlay graftProcedure or surgery
ridge preservation intervention with additional freeze dried bone allograft (FDBA) placed buccal to the socket
Ridge Preservation without overlay graftProcedure or surgery
ridge preservation without overlay graft / traditional FDBA placement into the socket only
| Study group | Role | What they receive |
|---|---|---|
| Cytoplast | Experimental | Patients will receive ridge preservation procedure with a Cytoplast barrier membrane Receives: Device: dense polytetrafluoroethylene (dPTFE) membrane Cytoplast; Procedure: Ridge Preservation with overlay graft; Procedure: Ridge Preservation without overlay graft |
| BioXclude | Experimental | Patients will receive ridge preservation procedure with a BioXclude barrier membrane Receives: Device: human amniotic-tissue derived membrane BioXclude; Procedure: Ridge Preservation with overlay graft; Procedure: Ridge Preservation without overlay graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar Ridge Width
Alveolar ridge dimensional change (horizontal) from Cone beam CT
Measured: from baseline to final cone beam CT scan (approximately 4 months)
Alveolar Ridge Height
Alveolar ridge dimensional change (vertical) from cone beam CT
Measured: from baseline to final cone beam CT scan (approximately 4 months)
Secondary outcomes (11)
Post-operative pain perception
self-report by patient on visual analog scale
Measured: 1 week after surgical extraction procedure
Platform size of implant placed
Whether or not the originally intended implant size could be placed
Measured: Implant surgery, approximtely 4 months after baseline
Keratinized tissue width (baseline)
Measured: pre-op / baseline assessment (after randomization)(prior to time=0)
Keratinized tissue width (final)
Measured: 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
Measured: 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
Measured: intra-operative surgical finding (extraction surgery)(time=0)
Buccal plate thickness
intra-operative measurements, presence or absence of a dehiscence / fenestration
Measured: intra-operative surgical finding (extraction surgery)(time = 0)
Buccal plate fenestration
determined at time of extraction surgery, and noted as a possible confounding variable
Measured: intra-operative surgical finding (extraction surgery)(time = 0)
Complications after surgery (infection)
infection, determined by presence of purulence, lymphadenopathy and/or febrile status
Measured: 0-4 months
Complications after surgery (membrane exfoliation)
dichotomous variable, presence or absence of the membrane for the duration of the study
Measured: 0-4 months
Peri-operative clinician's report (extraction difficulty)
subjective extraction difficulty, as reported by the clinician
Measured: intra-operative surgical finding (extraction surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Loss of Teeth Due to ExtractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eisenhower Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Brandon Coleman, Eisenhower Army Medical Center
- Investigators
- Brandon Coleman, DDS,MS, Principal investigator, US Army Fort Gordon DENTAC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482987
- Sponsor's protocol ID
- 408953-1
- Status last verified
- Feb 2017
- First submitted
- 19 Jun 2015
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Alveolar Ridge Preservation Techniques
- ClinicalTrials.gov ID
- NCT02482987
- Acronym / sponsor ID
- 408953-1
- Conditions
- Loss of Teeth Due to Extraction
- Keywords
- dental, extraction, socket preservation, ridge preservation, implant site preparation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Eisenhower Army Medical CenterUS federal agency
- Study start
- Jul 2015
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 26 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cytoplast | Experimental | Device: dense polytetrafluoroethylene (dPTFE) membrane Cytoplast, Procedure: Ridge Preservation with overlay graft, Procedure: Ridge Preservation without overlay graftPatients will receive ridge preservation procedure with a Cytoplast barrier membrane |
| BioXclude | Experimental | Device: human amniotic-tissue derived membrane BioXclude, Procedure: Ridge Preservation with overlay graft, Procedure: Ridge Preservation without overlay graftPatients will receive ridge preservation procedure with a BioXclude barrier membrane |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dense polytetrafluoroethylene (dPTFE) membrane CytoplastAlso: Cytoplastridge preservation intervention using the dPTFE membrane device | Device | Cytoplast |
| human amniotic-tissue derived membrane BioXcludeAlso: BioXcluderidge preservation intervention using the dPTFE membrane device | Device | BioXclude |
| Ridge Preservation with overlay graftridge preservation intervention with additional freeze dried bone allograft (FDBA) placed buccal to the socket | Procedure or surgery | BioXclude, Cytoplast |
| Ridge Preservation without overlay graftridge preservation without overlay graft / traditional FDBA placement into the socket only | Procedure or surgery | BioXclude, Cytoplast |
Primary outcome
Alveolar Ridge Width
Time frame: from baseline to final cone beam CT scan (approximately 4 months)
Alveolar ridge dimensional change (horizontal) from Cone beam CT
Alveolar Ridge Height
Time frame: from baseline to final cone beam CT scan (approximately 4 months)
Alveolar ridge dimensional change (vertical) from cone beam CT
11 secondary outcomes
Post-operative pain perception
Time frame: 1 week after surgical extraction procedure
Platform size of implant placed
Time frame: Implant surgery, approximtely 4 months after baseline
Keratinized tissue width (baseline)
Time frame: pre-op / baseline assessment (after randomization)(prior to time=0)
Keratinized tissue width (final)
Time frame: from pre-op assessment at time of randomization to implant surgery (4 months)
Elian classification (anticipated)
Time frame: pre-op / baseline assessment (after randomization)(prior to time=0)
Elian classification (actual)
Time frame: intra-operative surgical finding (extraction surgery)(time=0)
Buccal plate thickness
Time frame: intra-operative surgical finding (extraction surgery)(time = 0)
Buccal plate fenestration
Time frame: intra-operative surgical finding (extraction surgery)(time = 0)
Complications after surgery (infection)
Time frame: 0-4 months
Complications after surgery (membrane exfoliation)
Time frame: 0-4 months
Peri-operative clinician's report (extraction difficulty)
Time frame: intra-operative surgical finding (extraction surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brandon Coleman, DDS,MS principal investigator
US Army Fort Gordon DENTAC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dense polytetrafluoroethylene (dPTFE) membrane Cytoplast, human amniotic-tissue derived membrane BioXclude and Ridge Preservation with overlay graft in people with Loss of Teeth Due to Extraction, run by Eisenhower Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alveolar Ridge Width (time frame: from baseline to final cone beam CT scan (approximately 4 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2017.