Dental CariesPhase 3NCT00067392
Evaluation of Implants Placed Immediately or Delayed Into Extraction Sites
A Phase 3 study testing Dental Implant in people with Dental Caries, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
Trial summary
The purpose of this study is to determine the difference in success when placing implants immediately into an extraction site compared to delaying the implant placement until the extraction site has healed. Read more about this study
- Who is it for?
- Ages 21 months to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Dental Implant
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to May 2009
- Phase
- Phase 3
- 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 months to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All patients will be willing to be present for examination two times a year for at least three years, as well as maintenance cleanings twice a year 3 months prior to the data collection visit.
- All patients will be free of uncontrolled diabetes (any type), existing malignancy, and will not be receiving any therapy that suppresses their immune system, such as radiation, chemotherapy, or chronic steroid usage
- Need for extraction of a single rooted maxillary central or lateral incisor, canine, or premolar, with no signs of acute infection (purulent exudate, erythema, pain, and swelling).
- Patients will have bone present on all surfaces of the tooth within 3 mm of the gingival margin of the planned restoration, in order to provide sufficient bone to circumferentially cover the implant.
- All patients will have adequate space for satisfactory restoration of the edentulous space.
- Each patient's dentition will be free of active periodontal disease or exhibit controllable periodontal disease such that their teeth will clinically be non-mobile and have probing depths less than 3 mm.
- All prospective sites will have at least 2mm of attached or keratinized gingiva.
- The crestal bone width should be enough to accommodate either a 3.75 diameter implant for the central incisor, canine, and premolar sites, or a 3.25 mm diameter implant for the lateral incisor tooth sites. Bone height should be at least 14 mm for accommodation of the implant.
Who cannot join
- Patients with labial dehiscence defects greater than 3 mm from the proposed gingival margin of the planned restoration will be excluded from this study.
- Patients who cannot come for follow up due to conflicts of schedules will not be accepted into the study.
- Patients with advanced cardiovascular, pulmonary, renal, liver disease that place them in an ASA III or IV rating will be excluded. Post-menopausal women with known osteoporosis as determined by their medical internist, will be excluded. Patients with known alcohol abuse will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
LSU School of Dentistry
New Orleans, Louisiana, 70119
About this study
Official title: Prospective Evaluation of Immediate Temporized Implants
The purpose of this study is to determine the difference in success when placing implants immediately into an extraction site compared to delaying the implant placement until the extraction site has healed. In addition, the level of bone around the implants will be compared to determine if one method leads to better results over time.
Read the detailed description
This revised application is a clinical trial designed to evaluate crestal bone level changes when implants are placed into extraction sites and immediately provisionalized. Extraction of maxillary incisor teeth is a common procedure as documented in our school clinics. Traditional treatment when a tooth is extracted includes a period of healing followed by placement of an implant. Our preliminary data indicates that the delayed approach results in labial bone loss with resultant horizontal deficiency in over 50% of cases, requiring hard and soft tissue grafting to achieve a functional result. Additional preliminary data indicates that grafting the extraction site and/or immediate implant placement and provisionalization results in a functional restoration, without the need for additional adjunctive grafting procedures. It is unclear how the crestal bone levels change during healing of the extraction site prior to implant placement, in contrast to immediate implant placement, with immediate provisionalization with a crown. We hypothesize that there will be differences in the crestal bone levels (primary endpoint), and differences in soft tissue levels and indices (secondary endpoints) between implants immediately temporized, placed either delayed or immediately after tooth extraction, with more bone loss in the immediate placement group (experimental) compared to the delayed placement group (control). The long-term goal is to determine if the crestal bone remodeling after tooth extraction or the apical position of the implant determines the final level of the crestal bone. Two groups of 45 patients will be evaluated. All subjects will have a single rooted maxillary tooth extracted. One group will have the socket grafted with mineralized bone and allowed four months prior to implant placement. The crestal bone in this group will have remodeled during the four months of healing prior to implant placement. The second group will have the implant placed immediately after tooth extraction, thus the crestal bone will remodel in the presence of the implant and the immediately placed temporary restoration, as a one-stage procedure. For both groups, the implants will be immediately temporized with a crown after implant placement. Standardized hard and soft tissue data will be collected pre-extraction as baseline, and then prospectively for at least two years in this trial, to compare the methods and contrast the effectiveness of the proposed immediate restoration therapy.
- Conditions
- Dental Caries
- Being tested
- Dental Implant
- Keywords
- Partial edentulism, Bone atrophy, Bone healing
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental ImplantProcedure or surgery
Dental Implant 4 month time frame
What is being measured
The primary outcome is the main question the study is designed to answer.
Crestal bone levels adjacent to the implants
Measured: 4 months
Secondary outcomes (1)
Position of the papillary complex and facial gingival margin, and indicator of the inflammatory state of the perimplant tissues.
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 posted20 Aug 2003 (estimated)
- Study startNov 2003
- Primary completionApr 2008 (estimated)
- Study completionMay 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), Implant Innovations
- Investigators
- Michael S Block, DMD, Ph.D, Principal investigator, LSU School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00067392
- Sponsor's protocol ID
- NIDCR-14185
- Other IDs
- R01DE014185
- Status last verified
- Jul 2008
- First submitted
- 15 Aug 2003
- Last updated
- 9 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Immediate Temporized Implants
- ClinicalTrials.gov ID
- NCT00067392
- Acronym / sponsor ID
- NIDCR-14185
- Conditions
- Dental Caries
- Keywords
- Partial edentulism, Bone atrophy, Bone healing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), Implant Innovations
- Study start
- Nov 2003
- Primary completion
- Apr 2008 (estimated)
- Study completion
- May 2009 (estimated)
- First posted
- 20 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 determine the difference in success when placing implants immediately into an extraction site compared to delaying the implant placement until the extraction site has healed. In addition, the level of bone around the implants will be compared to determine if one method leads to better results over time.
Detailed description
This revised application is a clinical trial designed to evaluate crestal bone level changes when implants are placed into extraction sites and immediately provisionalized. Extraction of maxillary incisor teeth is a common procedure as documented in our school clinics. Traditional treatment when a tooth is extracted includes a period of healing followed by placement of an implant. Our preliminary data indicates that the delayed approach results in labial bone loss with resultant horizontal deficiency in over 50% of cases, requiring hard and soft tissue grafting to achieve a functional result. Additional preliminary data indicates that grafting the extraction site and/or immediate implant placement and provisionalization results in a functional restoration, without the need for additional adjunctive grafting procedures. It is unclear how the crestal bone levels change during healing of the extraction site prior to implant placement, in contrast to immediate implant placement, with immediate provisionalization with a crown. We hypothesize that there will be differences in the crestal bone levels (primary endpoint), and differences in soft tissue levels and indices (secondary endpoints) between implants immediately temporized, placed either delayed or immediately after tooth extraction, with more bone loss in the immediate placement group (experimental) compared to the delayed placement group (control). The long-term goal is to determine if the crestal bone remodeling after tooth extraction or the apical position of the implant determines the final level of the crestal bone. Two groups of 45 patients will be evaluated. All subjects will have a single rooted maxillary tooth extracted. One group will have the socket grafted with mineralized bone and allowed four months prior to implant placement. The crestal bone in this group will have remodeled during the four months of healing prior to implant placement. The second group will have the implant placed immediately after tooth extraction, thus the crestal bone will remodel in the presence of the implant and the immediately placed temporary restoration, as a one-stage procedure. For both groups, the implants will be immediately temporized with a crown after implant placement. Standardized hard and soft tissue data will be collected pre-extraction as baseline, and then prospectively for at least two years in this trial, to compare the methods and contrast the effectiveness of the proposed immediate restoration therapy.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 21 months to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- All patients will be willing to be present for examination two times a year for at least three years, as well as maintenance cleanings twice a year 3 months prior to the data collection visit.
- All patients will be free of uncontrolled diabetes (any type), existing malignancy, and will not be receiving any therapy that suppresses their immune system, such as radiation, chemotherapy, or chronic steroid usage
- Need for extraction of a single rooted maxillary central or lateral incisor, canine, or premolar, with no signs of acute infection (purulent exudate, erythema, pain, and swelling).
- Patients will have bone present on all surfaces of the tooth within 3 mm of the gingival margin of the planned restoration, in order to provide sufficient bone to circumferentially cover the implant.
- All patients will have adequate space for satisfactory restoration of the edentulous space.
Key exclusion criteria (3 listed)
- Patients with labial dehiscence defects greater than 3 mm from the proposed gingival margin of the planned restoration will be excluded from this study.
- Patients who cannot come for follow up due to conflicts of schedules will not be accepted into the study.
- Patients with advanced cardiovascular, pulmonary, renal, liver disease that place them in an ASA III or IV rating will be excluded. Post-menopausal women with known osteoporosis as determined by their medical internist, will be excluded. Patients with known alcohol abuse will be excluded.
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 |
|---|---|---|
| Dental ImplantDental Implant 4 month time frame | Procedure or surgery | – |
Primary outcome
Crestal bone levels adjacent to the implants
Time frame: 4 months
1 secondary outcome
Position of the papillary complex and facial gingival margin, and indicator of the inflammatory state of the perimplant tissues.
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2010.
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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.
Michael S Block, DMD, Ph.D principal investigator
LSU School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dental Implant in people with Dental Caries, run by Louisiana State University Health Sciences Center in New Orleans 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 8 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 9 Nov 2010. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Crestal bone levels adjacent to the implants (time frame: 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 9 Nov 2010.