Dental AlveolusNCT01572298
A Prospective Study: Alveolar Ridge Augmentation Using Tenting Screws, Acellular Dermal Matrix and Combination Particulate Grafts
A study testing allograft alone and allograft with autograft in people with Dental Alveolus and Oral Surgical Procedures, Preprosthetic, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
When a tooth or teeth are extracted, a defect in the bony ridge often forms. This loss of bone may make it impossible to place a dental implant. Guided bone regeneration procedures are used to re-establish a bone dimension sufficient to place a dental implant. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Alveolus, Oral Surgical Procedures, Preprosthetic
- What is being tested?
- allograft alone and allograft with autograft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Jul 2013
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- subject with a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and inadequate buccolingual dimension for dental implant placement as measured clinically and radiographically
- live within "catchment area" of 50 mile radius from San Antonio
Who cannot join
- unstable systemic disease (such as compromised immune system)
- patient taking steroids or other medications affecting bone metabolism
- patient with history of radiation therapy to head \& neck
- history of previous ridge augmentation procedure or pathology at local jaw site
- smokers who smoke > 10 cigarettes per day
Trial locations and contacts
1 site in 1 country.
United States1 site
University of texas Health Science Center Dental School at San Antonio
San Antonio, Texas, 78229-3900
About this study
Official title: A Prospective Study: Alveolar Ridge Augmentation Using Tenting Screws, Acellular Dermal Matrix and Combination Particulate Grafts.
When a tooth or teeth are extracted, a defect in the bony ridge often forms. This loss of bone may make it impossible to place a dental implant. Guided bone regeneration procedures are used to re-establish a bone dimension sufficient to place a dental implant. The primary objective of the study is to determine whether there is any difference in the gain of horizontal alveolar ridge width following guided bone regeneration surgery using a combined autogenous/allogenic particulate bone graft versus a particulate allograft alone. Autogenous bone has historically been considered the gold standard for alveolar ridge grafting; however, other materials including allografts and xenografts have also been used with excellent results. This study evaluates the potential benefits, or lack thereof, for using a combined autogenous/allograft approach versus an allograft alone. The investigators will clinically evaluate the efficacy of this technique and determine the difference in bone formation between groups following healing at 5 months by observing bone growth relative to heads of the tenting screws placed horizontally in the locations of greatest defect in the alveolar ridge. A biopsy of the healed site will be taken at the time of implant placement. The null hypothesis is that there will be no difference in the amount of horizontal ridge width gain at 5 months post-grafting between the two different grafting materials (allograft alone versus allograft combined with autogenous bone). Furthermore, the null hypothesis is that histologically, the combination graft (MinerOss®/particulate autograft) will have a similar percentage of vital bone present at 5 months compared to the allograft-alone group (MinerOss®).
Read the detailed description
Guided bone regeneration procedures are used to re-establish a bone dimension sufficient to place a dental implant. The primary objective of the study is to determine whether there is any difference in the gain of horizontal alveolar ridge width following guided bone regeneration surgery using a combined autogenous/allogenic particulate bone graft versus a particulate allograft alone. Autogenous bone has historically been considered the gold standard for alveolar ridge grafting; however, other materials including allografts and xenografts have also been used with excellent results. This study evaluates the potential benefits, or lack thereof, for using a combined autogenous/allograft approach versus an allograft alone. The investigators will clinically evaluate the efficacy of this technique and determine the difference in bone formation between groups following healing at 5 months by observing bone growth relative to heads of the tenting screws placed horizontally in the locations of greatest defect in the alveolar ridge. A biopsy of the healed site will be taken at the time of implant placement. The null hypothesis is that there will be no difference in the amount of horizontal ridge width gain at 5 months post-grafting between the two different grafting materials (allograft alone versus allograft combined with autogenous bone). Furthermore, the null hypothesis is that histologically, the combination graft (MinerOss®/particulate autograft) will have a similar percentage of vital bone present at 5 months compared to the allograft-alone group (MinerOss®).
- Being tested
- allograft alone, allograft with autograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allograft aloneDevice
use of MinerOss allograft plus Alloderm GBR membrane and tenting screws
allograft with autograftDevice
use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws
| Study group | Role | What they receive |
|---|---|---|
| allograft alone | Active comparator | guided bone regeneration with allograft alone (includes tenting screws and overlying allograft membrane material) Receives: Device: allograft alone |
| allograft with autograft | Experimental | guided bone regeneration with allograft and autograft combined (includes tenting screws and overlying allograft membrane material) Receives: Device: allograft with autograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gain in Horizontal Ridge Dimension
Measured: 5 months after surgery
Secondary outcomes (1)
Percentage of New Bone Formation (Histologic)
Measured: 5 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionJul 2013
- Study completionJul 2013
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.
- Other trials for Dental AlveolusStudies 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
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian L Mealey, DDS, MS, Principal investigator, Univ of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01572298
- Sponsor's protocol ID
- HSC20120108H
- Status last verified
- Oct 2015
- First submitted
- 3 Apr 2012
- Last updated
- 2 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study: Alveolar Ridge Augmentation Using Tenting Screws, Acellular Dermal Matrix and Combination Particulate Grafts.
- ClinicalTrials.gov ID
- NCT01572298
- Acronym / sponsor ID
- HSC20120108H
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 6 Apr 2012 (estimated)
- Results
- Posted 6 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
When a tooth or teeth are extracted, a defect in the bony ridge often forms. This loss of bone may make it impossible to place a dental implant. Guided bone regeneration procedures are used to re-establish a bone dimension sufficient to place a dental implant. The primary objective of the study is to determine whether there is any difference in the gain of horizontal alveolar ridge width following guided bone regeneration surgery using a combined autogenous/allogenic particulate bone graft versus a particulate allograft alone. Autogenous bone has historically been considered the gold standard for alveolar ridge grafting; however, other materials including allografts and xenografts have also been used with excellent results. This study evaluates the potential benefits, or lack thereof, for using a combined autogenous/allograft approach versus an allograft alone. The investigators will clinically evaluate the efficacy of this technique and determine the difference in bone formation between groups following healing at 5 months by observing bone growth relative to heads of the tenting screws placed horizontally in the locations of greatest defect in the alveolar ridge. A biopsy of the healed site will be taken at the time of implant placement. The null hypothesis is that there will be no difference in the amount of horizontal ridge width gain at 5 months post-grafting between the two different grafting materials (allograft alone versus allograft combined with autogenous bone). Furthermore, the null hypothesis is that histologically, the combination graft (MinerOss®/particulate autograft) will have a similar percentage of vital bone present at 5 months compared to the allograft-alone group (MinerOss®).
Detailed description
Guided bone regeneration procedures are used to re-establish a bone dimension sufficient to place a dental implant. The primary objective of the study is to determine whether there is any difference in the gain of horizontal alveolar ridge width following guided bone regeneration surgery using a combined autogenous/allogenic particulate bone graft versus a particulate allograft alone. Autogenous bone has historically been considered the gold standard for alveolar ridge grafting; however, other materials including allografts and xenografts have also been used with excellent results. This study evaluates the potential benefits, or lack thereof, for using a combined autogenous/allograft approach versus an allograft alone. The investigators will clinically evaluate the efficacy of this technique and determine the difference in bone formation between groups following healing at 5 months by observing bone growth relative to heads of the tenting screws placed horizontally in the locations of greatest defect in the alveolar ridge. A biopsy of the healed site will be taken at the time of implant placement. The null hypothesis is that there will be no difference in the amount of horizontal ridge width gain at 5 months post-grafting between the two different grafting materials (allograft alone versus allograft combined with autogenous bone). Furthermore, the null hypothesis is that histologically, the combination graft (MinerOss®/particulate autograft) will have a similar percentage of vital bone present at 5 months compared to the allograft-alone group (MinerOss®).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| allograft alone | Active comparator | Device: allograft aloneguided bone regeneration with allograft alone (includes tenting screws and overlying allograft membrane material) |
| allograft with autograft | Experimental | Device: allograft with autograftguided bone regeneration with allograft and autograft combined (includes tenting screws and overlying allograft membrane material) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- subject with a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and inadequate buccolingual dimension for dental implant placement as measured clinically and radiographically
- live within "catchment area" of 50 mile radius from San Antonio
Key exclusion criteria (5 listed)
- unstable systemic disease (such as compromised immune system)
- patient taking steroids or other medications affecting bone metabolism
- patient with history of radiation therapy to head \& neck
- history of previous ridge augmentation procedure or pathology at local jaw site
- smokers who smoke > 10 cigarettes per day
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 aloneuse of MinerOss allograft plus Alloderm GBR membrane and tenting screws | Device | allograft alone |
| allograft with autograftuse of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws | Device | allograft with autograft |
Primary outcome
Gain in Horizontal Ridge Dimension
Time frame: 5 months after surgery
1 secondary outcome
Percentage of New Bone Formation (Histologic)
Time frame: 5 months after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Brian L Mealey, DDS, MS principal investigator
Univ of Texas Health Science Center at San Antonio
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 alone and allograft with autograft in people with Dental Alveolus and Oral Surgical Procedures, Preprosthetic, run by The University of Texas Health Science Center at San Antonio 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 5 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 2 Jan 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2014). 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?
Gain in Horizontal Ridge Dimension (time frame: 5 months after surgery). 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 2 Jan 2018.