Dental ImplantationPhase 2NCT00066014
Clinical Investigation of Mandibular Implant Overdenture
A Phase 2 study testing Implant Overdenture Treatment in people with Dental Implantation, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of this study is to compare the effectiveness of three variable dental implant attachment methodologies in conjunction with lower dental-implant retained/supported complete overdenture treatment. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Dental Implantation
- What is being tested?
- Implant Overdenture Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1998to Jan 2007
- Phase
- Phase 2
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient;
- Male or female;
- At least one year of previous conventional complete denture treatment history;
- Willing to accept the conditions of the study and informed consent freely given;
- Ability to participate for 6 years;
- Able to understand and respond to self-reporting measurement scales used in the study;
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- Minimum 20-mm interarch distance at the estimated vertical dimension of occlusion;
- Adequate bone quality;
- Adequate bone quantity to accommodate minimally four 3.75-mm diameter by 7-mm long Brånemark implants.
Who cannot join
- Administrative or physical considerations which would seriously affect the surgical procedure or construe a hindrance for a six-year involvement;
- History of drug or alcohol abuse;
- Excessive smoking (1+ pack/day);
- Uncontrolled systemic disease;
- Inability to undergo minor oral surgery because of health or personal reasons;
- Irradiated surgical site;
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- Unrealistic expectations of the prosthodontic treatment outcome;
- Psychological or psychiatric conditions that could influence the subject's reaction to treatment;
- Acute or chronic TMD problems;
- pregnancy;
- Class II jaw relationship;
- Conventional dental treatment the treatment of choice.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
The purpose of this study is to compare the effectiveness of three variable dental implant attachment methodologies in conjunction with lower dental-implant retained/supported complete overdenture treatment. These three methods are all presently used by dental practitioners, but vary significantly in terms of added treatment cost and complexity. The study tests the hypothesis that the least complex and costly method provides an equivalent treatment outcome to other more complex and costly methods.
Read the detailed description
This project utilizes 30 subjects in a prospective, randomly assigned clinical study that uses a four-period, six sequence, three treatment crossover design to test the hypothesis that defined outcomes of variable implant overdenture treatments are equivalent. The project tests three overdenture treatment modalities, (1) four-implant, bar/clip-attached treatment, (2) two-implant, bar/clip-attached treatment, and (3) two-implant independently attached (O-ring) treatment. Each subject has four dental implants placed into the anterior mandible and new dentures are fabricated. After successful implant integration, subjects are randomly assigned to one of six sequences of treatment. Each treatment is followed for data collection for at least twelve months before the mandibular denture is modified to incorporate the next treatment in the sequence. Equivalence is measured in terms of prosthesis retention, stability, supporting and peri-implant tissue response, patient satisfaction/preference and treatment complications/failures.
Information from this study will assist dental practitioners during treatment planning in selecting appropriate and cost effective treatment choices. There is an inverse relationship between edentulism in the U.S. population and socioeconomic status. If less costly and simplified treatment methods are shown to provide an equivalent treatment outcome to more costly/complex methods, these simplified treatments can be used to treat a larger percentage of the edentulous population.
- Conditions
- Dental Implantation
- Being tested
- Implant Overdenture Treatment
- Keywords
- Dental Implantation-Osseointegrated, Dentures, Dental Prostheses, Denture, Implant-Supported
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant Overdenture TreatmentProcedure or surgery
All overdenture treatment modalities were provided to each subject using a crossover design.
| Study group | Role | What they receive |
|---|---|---|
| treatment modalities changed for comparison | Active comparator | All subjects experienced all treatment modalities being studied. Receives: Procedure: Implant Overdenture Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of implant overdenture clinical modalities using clinical measures to compare treatment outcomes
Measured: 6 month and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2003 (estimated)
- Study startNov 1998
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantationStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), Nobel Biocare
- Responsible party
- Sponsor
- Investigators
- David R Burns, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00066014
- Sponsor's protocol ID
- NIDCR-12204
- Other IDs
- R01DE012204
- Status last verified
- Jan 2010
- First submitted
- 1 Aug 2003
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of Mandibular Implant Overdenture
- ClinicalTrials.gov ID
- NCT00066014
- Acronym / sponsor ID
- NIDCR-12204
- Conditions
- Dental Implantation
- Keywords
- Dental Implantation-Osseointegrated, Dentures, Dental Prostheses, Denture, Implant-Supported
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), Nobel Biocare
- Study start
- Nov 1998
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 5 Aug 2003 (estimated)
- 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 purpose of this study is to compare the effectiveness of three variable dental implant attachment methodologies in conjunction with lower dental-implant retained/supported complete overdenture treatment. These three methods are all presently used by dental practitioners, but vary significantly in terms of added treatment cost and complexity. The study tests the hypothesis that the least complex and costly method provides an equivalent treatment outcome to other more complex and costly methods.
Detailed description
This project utilizes 30 subjects in a prospective, randomly assigned clinical study that uses a four-period, six sequence, three treatment crossover design to test the hypothesis that defined outcomes of variable implant overdenture treatments are equivalent. The project tests three overdenture treatment modalities, (1) four-implant, bar/clip-attached treatment, (2) two-implant, bar/clip-attached treatment, and (3) two-implant independently attached (O-ring) treatment. Each subject has four dental implants placed into the anterior mandible and new dentures are fabricated. After successful implant integration, subjects are randomly assigned to one of six sequences of treatment. Each treatment is followed for data collection for at least twelve months before the mandibular denture is modified to incorporate the next treatment in the sequence. Equivalence is measured in terms of prosthesis retention, stability, supporting and peri-implant tissue response, patient satisfaction/preference and treatment complications/failures.
Information from this study will assist dental practitioners during treatment planning in selecting appropriate and cost effective treatment choices. There is an inverse relationship between edentulism in the U.S. population and socioeconomic status. If less costly and simplified treatment methods are shown to provide an equivalent treatment outcome to more costly/complex methods, these simplified treatments can be used to treat a larger percentage of the edentulous population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment modalities changed for comparison | Active comparator | Procedure: Implant Overdenture TreatmentAll subjects experienced all treatment modalities being studied. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult patient;
- Male or female;
- At least one year of previous conventional complete denture treatment history;
- Willing to accept the conditions of the study and informed consent freely given;
- Ability to participate for 6 years;
Key exclusion criteria (12 listed)
- Administrative or physical considerations which would seriously affect the surgical procedure or construe a hindrance for a six-year involvement;
- History of drug or alcohol abuse;
- Excessive smoking (1+ pack/day);
- Uncontrolled systemic disease;
- Inability to undergo minor oral surgery because of health or personal reasons;
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 |
|---|---|---|
| Implant Overdenture TreatmentAll overdenture treatment modalities were provided to each subject using a crossover design. | Procedure or surgery | treatment modalities changed for comparison |
Primary outcome
Comparison of implant overdenture clinical modalities using clinical measures to compare treatment outcomes
Time frame: 6 month and 12 month
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 22 Feb 2012.
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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.
David R Burns principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Implant Overdenture Treatment in people with Dental Implantation, run by Virginia Commonwealth University 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 9 inclusion and 12 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 22 Feb 2012. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Comparison of implant overdenture clinical modalities using clinical measures to compare treatment outcomes (time frame: 6 month and 12 month). 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 22 Feb 2012.