Alveolar Ridge AugmentationsPhase 1NCT03422692
Socket Preservation: A Clinical and Histological Study
A Phase 1 study testing BioXclude amnion-chorion membrane and Mem-Lok collagenous membrane in people with Alveolar Ridge Augmentations, run by University of Kentucky at 1 site in United States.
Trial summary
The objective of this study is to investigate the use of human amnion chorion membrane (BioXclude®) as an exposed barrier in ridge preservation and whether the intentional exposure of this membrane to oral environment will adversely affect ridge healing, dimensions, and bone vitality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alveolar Ridge Augmentations
- What is being tested?
- BioXclude amnion-chorion membrane and Mem-Lok collagenous membrane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2013to 1 Oct 2015
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- must have an unsalvageable tooth with extraction planned with delayed implant
- extraction sockets must have intact buccal and lingual cortical plates
Who cannot join
- completely endentulous
- plan for a full mouth tooth extraction
- radiation therapy
- uncontrolled systemic disorders
- acute odontogenic infections
- smoking >10 cigarettes/day
- taking anti-resorptive meds
- pregnant or may become pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky College of Dentistry
Lexington, Kentucky, 40536
About this study
Official title: Comparison of Human Amnion Chorionic and Typ1 Bovine Collagen Membranes for Socket Preservation: A Clinical and Histological Study
The objective of this study is to investigate the use of human amnion chorion membrane (BioXclude®) as an exposed barrier in ridge preservation and whether the intentional exposure of this membrane to oral environment will adversely affect ridge healing, dimensions, and bone vitality. This is a randomized clinical study.
Read the detailed description
Alveolar ridge resorption is common sequelae following tooth extraction and presents a challenge for implant placement. The width of the alveolar ridge is known to be resorbed to 30% and 50% of it is original dimension after 3 and 12 months respectively when the extraction socket was left to heal on its own(Schropp, Wenzel et al. 2003). Clinical studies have investigated the socket augmentation technique to prevent the collapse of socket dimension after extraction, and to maintain the ridge width and height for implant placement. This technique includes grafting the socket with bone particulate and then covering the grafted socket with a barrier membrane. (Iasella, Greenwell et al. 2003; Wang and Tsao 2008). In socket augmentation, the role of bone particles is to induce the formation of bone or to provide a scaffold for the new bone formation. The role of the membrane is to keep bone particles within the socket and to exclude the epithelial and connective tissue cells from populating the extraction socket, thus allow the bone cells populating the socket and forming new bone. (Smukler, Landi et al. 1999). The ideal membrane should have no immunological responses, facilitate tissue integration, maintain the clot space, and have good handling properties (Scantlebury 1993; Rakhmatia, Ayukawa et al. 2013). A variety of resorbable and non-resorbable barrier membranes used in socket preservation have been reported in clinical studies. They have clearly shown variable rates of new bone formation prior to implant placement.(Smukler, Landi et al. 1999) (Fotek, Neiva et al. 2009). A xenograft collagen membrane was used in several clinical studies for socket augmentation (Sevor and Meffert 1992; Sevor, Meffert et al. 1993; Iasella, Greenwell et al. 2003; Wang and Tsao 2008).
Another type of resorbable membrane that has been investigated for socket augmentation is the allograft placental membrane. Processed, dehydrated and sterilized human placental amnion chorionic membrane (ACM) has been successfully used in many clinical applications in soft tissue repair and regeneration. (Trelford and Trelford-Sauder 1979; Nakamura, Koizumi et al. 2003).
ACM have also been used in human clinical studies to assess gingival healing and bone formation in augmented sockets and osseous defects.(Wallace 2010; Holtzclaw 2011; Wallace 2011).
In this study, the investigators aim to compare two resorbable membrane (allograft placental-BioXclude versus xenograft collagen- Mem Lok) in order to find out whether one of these membrane could provide better soft tissue healing and better bone quality before implants are placed. Both membranes are FDA approved and tested for human use. Their proposed use in this study is FDA approved.
- Conditions
- Alveolar Ridge Augmentations
- Being tested
- BioXclude amnion-chorion membrane, Mem-Lok collagenous membrane
- Keywords
- Resorbable membrane, amnion-chorion membrane, collagen membrane, ridge preservation.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioXclude amnion-chorion membraneBiological
Also called BioXclude membrane
BioXclude will be used for the prevention of alveolar ridge resorption via socket bone graft and amnion-chorion membrane closure
Mem-Lok collagenous membraneBiological
Also called Mem-Lok
Mem-Lok will be used for the prevention of alveolar ridge resorption via socket bone graft and collagenous membrane closure
| Study group | Role | What they receive |
|---|---|---|
| BioXlude memebrane | Experimental | Subjects in this arm will receive demineralized freeze dried bone allograft covered with BioXclude amnion-chorion membrane following tooth extraction Receives: Biological: BioXclude amnion-chorion membrane |
| Mem-Lok | Active comparator | subjects in this arm will receive demineralized freeze dried bone allograft covered with Mem-Lok collagenous membrane following tooth extraction Receives: Biological: Mem-Lok collagenous membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone quality
Mean vital bone formation using histomorphometric analysis
Measured: 19.5 weeks post intervention
Secondary outcomes (1)
Bone quantity
vertical and horizontal measurements of alveolar ridge
Measured: 19.5 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start1 Oct 2013
- Primary completion1 Oct 2015
- Study completion1 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Ridge AugmentationsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohanad Al-Sabbagh, University of Kentucky
- Investigators
- Mohanad Al-Sabbagh, DDS, MS, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422692
- Sponsor's protocol ID
- Snoasis
- Status last verified
- Feb 2018
- First submitted
- 30 Jan 2018
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Human Amnion Chorionic and Typ1 Bovine Collagen Membranes for Socket Preservation: A Clinical and Histological Study
- ClinicalTrials.gov ID
- NCT03422692
- Acronym / sponsor ID
- Snoasis
- Conditions
- Alveolar Ridge Augmentations
- Keywords
- Resorbable membrane, amnion-chorion membrane, collagen membrane, ridge preservation.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 1 Oct 2015 (actual)
- Study completion
- 1 Oct 2015 (actual)
- First posted
- 6 Feb 2018 (actual)
- 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 objective of this study is to investigate the use of human amnion chorion membrane (BioXclude®) as an exposed barrier in ridge preservation and whether the intentional exposure of this membrane to oral environment will adversely affect ridge healing, dimensions, and bone vitality. This is a randomized clinical study.
Detailed description
Alveolar ridge resorption is common sequelae following tooth extraction and presents a challenge for implant placement. The width of the alveolar ridge is known to be resorbed to 30% and 50% of it is original dimension after 3 and 12 months respectively when the extraction socket was left to heal on its own(Schropp, Wenzel et al. 2003). Clinical studies have investigated the socket augmentation technique to prevent the collapse of socket dimension after extraction, and to maintain the ridge width and height for implant placement. This technique includes grafting the socket with bone particulate and then covering the grafted socket with a barrier membrane. (Iasella, Greenwell et al. 2003; Wang and Tsao 2008). In socket augmentation, the role of bone particles is to induce the formation of bone or to provide a scaffold for the new bone formation. The role of the membrane is to keep bone particles within the socket and to exclude the epithelial and connective tissue cells from populating the extraction socket, thus allow the bone cells populating the socket and forming new bone. (Smukler, Landi et al. 1999). The ideal membrane should have no immunological responses, facilitate tissue integration, maintain the clot space, and have good handling properties (Scantlebury 1993; Rakhmatia, Ayukawa et al. 2013). A variety of resorbable and non-resorbable barrier membranes used in socket preservation have been reported in clinical studies. They have clearly shown variable rates of new bone formation prior to implant placement.(Smukler, Landi et al. 1999) (Fotek, Neiva et al. 2009). A xenograft collagen membrane was used in several clinical studies for socket augmentation (Sevor and Meffert 1992; Sevor, Meffert et al. 1993; Iasella, Greenwell et al. 2003; Wang and Tsao 2008).
Another type of resorbable membrane that has been investigated for socket augmentation is the allograft placental membrane. Processed, dehydrated and sterilized human placental amnion chorionic membrane (ACM) has been successfully used in many clinical applications in soft tissue repair and regeneration. (Trelford and Trelford-Sauder 1979; Nakamura, Koizumi et al. 2003).
ACM have also been used in human clinical studies to assess gingival healing and bone formation in augmented sockets and osseous defects.(Wallace 2010; Holtzclaw 2011; Wallace 2011).
In this study, the investigators aim to compare two resorbable membrane (allograft placental-BioXclude versus xenograft collagen- Mem Lok) in order to find out whether one of these membrane could provide better soft tissue healing and better bone quality before implants are placed. Both membranes are FDA approved and tested for human use. Their proposed use in this study is FDA approved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BioXlude memebrane | Experimental | Biological: BioXclude amnion-chorion membraneSubjects in this arm will receive demineralized freeze dried bone allograft covered with BioXclude amnion-chorion membrane following tooth extraction |
| Mem-Lok | Active comparator | Biological: Mem-Lok collagenous membranesubjects in this arm will receive demineralized freeze dried bone allograft covered with Mem-Lok collagenous membrane following tooth extraction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- must have an unsalvageable tooth with extraction planned with delayed implant
- extraction sockets must have intact buccal and lingual cortical plates
Key exclusion criteria (8 listed)
- completely endentulous
- plan for a full mouth tooth extraction
- radiation therapy
- uncontrolled systemic disorders
- acute odontogenic infections
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 |
|---|---|---|
| BioXclude amnion-chorion membraneAlso: BioXclude membraneBioXclude will be used for the prevention of alveolar ridge resorption via socket bone graft and amnion-chorion membrane closure | Biological | BioXlude memebrane |
| Mem-Lok collagenous membraneAlso: Mem-LokMem-Lok will be used for the prevention of alveolar ridge resorption via socket bone graft and collagenous membrane closure | Biological | Mem-Lok |
Primary outcome
bone quality
Time frame: 19.5 weeks post intervention
Mean vital bone formation using histomorphometric analysis
1 secondary outcome
Bone quantity
Time frame: 19.5 weeks post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- Individual participant dataSharing planned: No
Related trials for Alveolar Ridge Augmentations
Not yet recruiting
Autogenous and Xenograft Bone Mix in Alveolar Ridge Reconstruction
Horizontal Alveolar Ridge Deficiency
Not yet recruitingPhase 1/2
Alveolar Ridge Preservation (ARP) Study Using Alloplastic Biomaterial and a Resorbable Synthetic Membrane. A Digital Workflow (CBCT/Scanner) Evaluates Hard and Soft Tissue Volumetric Changes at 4 Months, Validating Support for the Gingival Phenotype and Buccal Bone Plate.
Alveolar Ridge Augmentation, Bone Substitutes
Not yet recruiting
Comparison of Three Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
Not yet recruiting
Comparison of Two Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
Not yet recruiting
HydroGraft for Mandibular Horizontal Ridge Atrophy Augmentation.
Alveolar Ridge Atrophy
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.
Mohanad Al-Sabbagh, DDS, MS principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BioXclude amnion-chorion membrane and Mem-Lok collagenous membrane in people with Alveolar Ridge Augmentations, run by University of Kentucky 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: finished, as of the sponsor's last update on 14 Feb 2018. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
bone quality (time frame: 19.5 weeks post intervention). 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 14 Feb 2018.