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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.

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 groups in NCT03422692
Study groupRoleWhat they receive
BioXlude memebraneExperimentalSubjects 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-LokActive comparatorsubjects 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.

  1. bone quality

    Mean vital bone formation using histomorphometric analysis

    Measured: 19.5 weeks post intervention

Secondary outcomes (1)
  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.

  1. First posted6 Feb 2018
  2. Study start1 Oct 2013
  3. Primary completion1 Oct 2015
  4. Study completion1 Oct 2015

Resources

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)
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

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.

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