Tooth LossNCT02330523
An RCT Comparing Xenograft and Allograft for Ridge Preservation
A study testing allograft + x-link collagen membrane and xenograft + non-x-link collagen in people with Tooth Loss, run by McGuire Institute at 1 site in United States.
Trial summary
To compare the effectiveness of demineralized freeze-dried bone allograft + cross-linked collagen membrane with xenograft + non-cross-linked collagen membrane for posterior extraction socket ridge preservation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tooth Loss
- What is being tested?
- allograft + x-link collagen membrane and xenograft + non-x-link collagen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects 18 to 70-yrs of age
- Subject indicated for posterior tooth extraction (from 1st premolar to 1st molar) intended for implant placement, with adjacent teeth intact (for stent indexing)
- Subjects with extraction site bony buccal dehiscences at least 1/3 the depth of socket and 1/3 the mesial-distal width of tooth socket
- Subjects will have read, understood and signed an institutional review board (IRB) approved Informed Consent Form (ICF).
- Subjects must be able and willing to follow study procedures and instructions.
Who cannot join
- Subjects with a history of any tobacco use within the last six months.
- Subjects with healing disorders (i.e., diabetes mellitus, cancer, HIV, bone metabolic diseases) that could compromise wound healing and/ or preclude implant surgery; or who are currently receiving or have received within two months prior to study entry, systemic corticosteroids, immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and preclude periodontal surgery.
- Subjects taking intramuscular or intravenous bisphosphonates.
- Subjects who have a known allergy or sensitivity to alginate, latex, collagen or acrylic.
- Female subjects who are pregnant or lactating, or who intend to become pregnant during the study duration
- Subjects participating in other clinical studies involving therapeutic intervention (either medical or dental).
- Subjects, who in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Controlled, Multi-center Study With Direct Measure and Histological Evaluation Comparing Xenograft and Allograft for Posterior Buccal Dehiscence Extraction Site Ridge Preservation
To compare the effectiveness of demineralized freeze-dried bone allograft + cross-linked collagen membrane with xenograft + non-cross-linked collagen membrane for posterior extraction socket ridge preservation.
Read the detailed description
Buccal bony wall loss is a common sequela following tooth extraction, and guided bone regeneration (GBR) is a common treatment for the regeneration of ridge form and volume preservation allowing dental implant placement. Many bone augmentation biomaterials are employed to accomplish GBR, and both the medical/ dental community and, subsequently, patients benefit from understanding whether a given GBR biomaterial might be more efficacious. To this end, a randomized, case series comparison of allograft + x-linked collagen membrane versus xenograft + non-x-linked collagen membrane would be beneficial to both the dental community and patients.
The study compares the effectiveness of demineralized freeze-dried bone allograft + x-linked collagen membrane with xenograft + non-x-linked collagen membrane for posterior region extraction socket ridge preservation.
- Conditions
- Tooth Loss
- Being tested
- allograft + x-link collagen membrane, xenograft + non-x-link collagen
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allograft + x-link collagen membraneDevice
Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Allograft will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. X-link collagen membrane will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0.
xenograft + non-x-link collagenDevice
Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Xenograft will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. Non-x-link collagen membrane will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0.
| Study group | Role | What they receive |
|---|---|---|
| allograft + x-link collagen membrane | Active comparator | Demineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction. Receives: Device: allograft + x-link collagen membrane |
| xenograft + non-x-link collagen | Active comparator | Xenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction. Receives: Device: xenograft + non-x-link collagen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Ridge Buccal-Lingual and Apico-Coronal Measures at 6 Months
The primary efficacy parameter will be ridge volume preservation as measured apico-coronal and buccal-lingual using a preformed and marked stent.
Measured: Six Months
Secondary outcomes (2)
New Bone Plus Graft Content at 6-months
New bone and graft content are measured as histomorphometric % vital bone and % mineral (graft remnants) from mid-section bone core biopsies. Histomorphometric analyses are performed with imaging software on composite overview scans. The area of new healing (versus old/ original bony tissues) is demarcated in each section. Within this area, the percentage contributions of each tissue type within the overall area of newly healed tissue is computed, i.e., new bone plus graft content added with connective tissue/ marrow elements totals 100% of the "new healing" area.
Measured: Six Months
Wound Closure at 4-weeks
Suture line gap will be measured (buccal-lingual) with a UNC-15 Probe, rounding down to the nearest 0.5 mm.
Measured: 4-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2015 (estimated)
- Study startApr 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tooth LossStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGuire Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Geistlich Pharma AG
- Responsible party
- Sponsor
- Investigators
- Eric T Scheyer, DDS, MS, Principal investigator, The McGuire Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330523
- Sponsor's protocol ID
- 13530232
- Status last verified
- Dec 2015
- First submitted
- 31 Dec 2014
- Last updated
- 18 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Cook DC, Mealey BL. Histologic comparison of healing following tooth extraction with ridge preservation using two different xenograft protocols. J Periodontol. 2013 May;84(5):585-94. doi: 10.1902/jop.2012.120219. Epub 2012 Jun 9.
PubMed 22680300
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled, Multi-center Study With Direct Measure and Histological Evaluation Comparing Xenograft and Allograft for Posterior Buccal Dehiscence Extraction Site Ridge Preservation
- ClinicalTrials.gov ID
- NCT02330523
- Acronym / sponsor ID
- 13530232
- Conditions
- Tooth Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- McGuire InstituteIndustry (pharma, biotech, devices)
- Collaborators
- Geistlich Pharma AG
- Study start
- Apr 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 Jan 2015 (estimated)
- Results
- Posted 18 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the effectiveness of demineralized freeze-dried bone allograft + cross-linked collagen membrane with xenograft + non-cross-linked collagen membrane for posterior extraction socket ridge preservation.
Detailed description
Buccal bony wall loss is a common sequela following tooth extraction, and guided bone regeneration (GBR) is a common treatment for the regeneration of ridge form and volume preservation allowing dental implant placement. Many bone augmentation biomaterials are employed to accomplish GBR, and both the medical/ dental community and, subsequently, patients benefit from understanding whether a given GBR biomaterial might be more efficacious. To this end, a randomized, case series comparison of allograft + x-linked collagen membrane versus xenograft + non-x-linked collagen membrane would be beneficial to both the dental community and patients.
The study compares the effectiveness of demineralized freeze-dried bone allograft + x-linked collagen membrane with xenograft + non-x-linked collagen membrane for posterior region extraction socket ridge preservation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| allograft + x-link collagen membrane | Active comparator | Device: allograft + x-link collagen membraneDemineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction. |
| xenograft + non-x-link collagen | Active comparator | Device: xenograft + non-x-link collagenXenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects 18 to 70-yrs of age
- Subject indicated for posterior tooth extraction (from 1st premolar to 1st molar) intended for implant placement, with adjacent teeth intact (for stent indexing)
- Subjects with extraction site bony buccal dehiscences at least 1/3 the depth of socket and 1/3 the mesial-distal width of tooth socket
- Subjects will have read, understood and signed an institutional review board (IRB) approved Informed Consent Form (ICF).
- Subjects must be able and willing to follow study procedures and instructions.
Key exclusion criteria (7 listed)
- Subjects with a history of any tobacco use within the last six months.
- Subjects with healing disorders (i.e., diabetes mellitus, cancer, HIV, bone metabolic diseases) that could compromise wound healing and/ or preclude implant surgery; or who are currently receiving or have received within two months prior to study entry, systemic corticosteroids, immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and preclude periodontal surgery.
- Subjects taking intramuscular or intravenous bisphosphonates.
- Subjects who have a known allergy or sensitivity to alginate, latex, collagen or acrylic.
- Female subjects who are pregnant or lactating, or who intend to become pregnant during the study duration
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 |
|---|---|---|
| allograft + x-link collagen membraneFollowing resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Allograft will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. X-link collagen membrane will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0. | Device | allograft + x-link collagen membrane |
| xenograft + non-x-link collagenFollowing resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Xenograft will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. Non-x-link collagen membrane will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0. | Device | xenograft + non-x-link collagen |
Primary outcome
Bone Ridge Buccal-Lingual and Apico-Coronal Measures at 6 Months
Time frame: Six Months
The primary efficacy parameter will be ridge volume preservation as measured apico-coronal and buccal-lingual using a preformed and marked stent.
2 secondary outcomes
New Bone Plus Graft Content at 6-months
Time frame: Six Months
Wound Closure at 4-weeks
Time frame: 4-weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22680300Cook DC, Mealey BL. Histologic comparison of healing following tooth extraction with ridge preservation using two different xenograft protocols. J Periodontol. 2013 May;84(5):585-94. doi: 10.1902/jop.2012.120219. Epub 2012 Jun 9.
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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.
Eric T Scheyer, DDS, MS principal investigator
The McGuire Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing allograft + x-link collagen membrane and xenograft + non-x-link collagen in people with Tooth Loss, run by McGuire Institute 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 5 inclusion and 7 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 18 Feb 2016. 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?
Yes. Results are posted in the registry (first posted 18 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Ridge Buccal-Lingual and Apico-Coronal Measures at 6 Months (time frame: Six Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02330523, which also lists 1 linked publication.
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 18 Feb 2016.