Clinical EfficacyNCT01431131
Ridge Preservation Comparing an Intrasocket Graft Alone to an Intrasocket Graft Plus a Facial Overlay Graft
A study testing Intrasocket graft and Intrasocket plus facial overlay graft in people with Clinical Efficacy, run by University of Louisville at 1 site in United States.
Trial summary
The purpose of this study is to compare two methods of ridge preservation in the maxillary anterior esthetic zone to determine the best method to establish adequate bone and soft tissue to accommodate implant placement. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Clinical Efficacy
- What is being tested?
- Intrasocket graft and Intrasocket plus facial overlay graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Jul 2012
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have one non-molar tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by at least one tooth.
- Healthy person that is at least 18 years old.
- Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.
Who cannot join
- Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.
- Molar teeth.
- Presence of or history of osteonecrosis of the jaws.
- Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of the duration.
- Patients who have been treated with oral bisphosphonates for more than three years.
- Pregnant women due to the possibility of miscarriage.
Show all 11Show fewer
- Patients with an allergy to any material or medication used in the study.
- Patients who need prophylactic antibiotics.
- Previous head and neck radiation therapy.
- Chemotherapy in the previous 12 months.
- Patients on long term NSAID or steroid therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Graduate Periodontics Clinic, School of Dentistry, University of Louisville
Louisville, Kentucky, 40202
About this study
Official title: Ridge Preservation Comparing a Socket Allograft Alone to a Socket Allograft Plus a Facial Overlay Xenograft: A Clinical and Histologic Study In Humans
The purpose of this study is to compare two methods of ridge preservation in the maxillary anterior esthetic zone to determine the best method to establish adequate bone and soft tissue to accommodate implant placement. For the positive control group a mineralized cancellous allograft will be placed in the extraction socket. For the test group a mineralized cancellous allograft will be placed in the extraction socket plus an additional graft will be placed to overlay the facial surface of the socket that will be composed of bovine xenograft material. Outcomes will be clinical horizontal and vertical dimensional change and histologic analysis of the graft material at 4 months post-placement.
Read the detailed description
Subjects met the eligibility criteria if they were at least 18 years of age and had one nonmolar tooth requiring extraction that would be replaced by a dental implant. Extraction sites were bordered by at least one tooth. Exclusion criteria included: 1) debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium; 2) molar extraction sites; 3) presence of or history of osteonecrosis of the jaws; 4) history of IV bisphosphonate treatment; 5) history of oral bisphosphonate treatment for more than three years; 6) pregnancy or lactation; 7) known allergy to any material or medication used in the study; 8) required antibiotic prophylaxis; 9) previous head and neck radiation therapy; 10) history of chemotherapy in the last 12 months; 11) long term steroid or non-steroidal anti-inflammatory drug therapy; or 12) failure to sign an informed consent approved by the Human Studies Committee. Patients were excluded post-treatment if they developed infection or had an adverse reaction to any of the materials used in the study.
- Conditions
- Clinical Efficacy
- Being tested
- Intrasocket graft, Intrasocket plus facial overlay graft
- Keywords
- graft placement, bone resorption
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrasocket graftProcedure or surgery
Intrasocket mineralized cancellous allograft
Intrasocket plus facial overlay graftProcedure or surgery
Intrasocket mineralized cancellous allograft plus a facial overlay graft of bovine xenograft
| Study group | Role | What they receive |
|---|---|---|
| Intrasocket graft | Active comparator | Positive control Receives: Procedure: Intrasocket graft |
| Intrasocket plus facial overlay graft | Experimental | Intrasocket cancellous allograft plus a facial overlay bovine xenograft Receives: Procedure: Intrasocket plus facial overlay graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal Ridge Dimension
WIll be measured with a digital caliper at baseline and 4 months.
Measured: Baseline and 4 months
Secondary outcomes (1)
Histologic Healing of the Osseous Graft
Histologic analysis to determine vital bone, nonvital bone, and trabecular space percentages
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionJul 2012
- Study completionJul 2012
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 Clinical EfficacyStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henry Greenwell, University of Louisville
- Investigators
- Henry Greenwell, DMD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01431131
- Sponsor's protocol ID
- 11.0352
- Status last verified
- Dec 2016
- First submitted
- 7 Sep 2011
- Last updated
- 31 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ridge Preservation Comparing a Socket Allograft Alone to a Socket Allograft Plus a Facial Overlay Xenograft: A Clinical and Histologic Study In Humans
- ClinicalTrials.gov ID
- NCT01431131
- Acronym / sponsor ID
- 11.0352
- Conditions
- Clinical Efficacy
- Keywords
- graft placement, bone resorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 9 Sep 2011 (estimated)
- Results
- Posted 31 Jan 2017
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 methods of ridge preservation in the maxillary anterior esthetic zone to determine the best method to establish adequate bone and soft tissue to accommodate implant placement. For the positive control group a mineralized cancellous allograft will be placed in the extraction socket. For the test group a mineralized cancellous allograft will be placed in the extraction socket plus an additional graft will be placed to overlay the facial surface of the socket that will be composed of bovine xenograft material. Outcomes will be clinical horizontal and vertical dimensional change and histologic analysis of the graft material at 4 months post-placement.
Detailed description
Subjects met the eligibility criteria if they were at least 18 years of age and had one nonmolar tooth requiring extraction that would be replaced by a dental implant. Extraction sites were bordered by at least one tooth. Exclusion criteria included: 1) debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium; 2) molar extraction sites; 3) presence of or history of osteonecrosis of the jaws; 4) history of IV bisphosphonate treatment; 5) history of oral bisphosphonate treatment for more than three years; 6) pregnancy or lactation; 7) known allergy to any material or medication used in the study; 8) required antibiotic prophylaxis; 9) previous head and neck radiation therapy; 10) history of chemotherapy in the last 12 months; 11) long term steroid or non-steroidal anti-inflammatory drug therapy; or 12) failure to sign an informed consent approved by the Human Studies Committee. Patients were excluded post-treatment if they developed infection or had an adverse reaction to any of the materials used in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrasocket graft | Active comparator | Procedure: Intrasocket graftPositive control |
| Intrasocket plus facial overlay graft | Experimental | Procedure: Intrasocket plus facial overlay graftIntrasocket cancellous allograft plus a facial overlay bovine xenograft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have one non-molar tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by at least one tooth.
- Healthy person that is at least 18 years old.
- Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.
Key exclusion criteria (11 listed)
- Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.
- Molar teeth.
- Presence of or history of osteonecrosis of the jaws.
- Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of the duration.
- Patients who have been treated with oral bisphosphonates for more than three years.
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 |
|---|---|---|
| Intrasocket graftIntrasocket mineralized cancellous allograft | Procedure or surgery | Intrasocket graft |
| Intrasocket plus facial overlay graftIntrasocket mineralized cancellous allograft plus a facial overlay graft of bovine xenograft | Procedure or surgery | Intrasocket plus facial overlay graft |
Primary outcome
Horizontal Ridge Dimension
Time frame: Baseline and 4 months
WIll be measured with a digital caliper at baseline and 4 months.
1 secondary outcome
Histologic Healing of the Osseous Graft
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- 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.
Henry Greenwell, DMD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrasocket graft and Intrasocket plus facial overlay graft in people with Clinical Efficacy, run by University of Louisville 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 3 inclusion and 11 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 31 Jan 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?
Yes. Results are posted in the registry (first posted 31 Jan 2017). 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?
Horizontal Ridge Dimension (time frame: Baseline and 4 months). 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 31 Jan 2017.