Dental ImplantNCT00607022
A Randomized Prospective Clinical Trial Comparing Single Tooth Implant 3 Loading Protocols
A study testing dental implant in people with Dental Implant, run by Clark Stanford at 1 site in United States.
Trial summary
This is a research study to test the clinical procedure and not the FDA approved medical device. This project will screen up to 80 volunteers to enroll 40 active subjects to receive a single tooth implant on an anterior (incisor/canine) or pre-molar tooth in the mandible or maxilla (no implants will be placed in molar… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant
- What is being tested?
- dental implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Jun 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patient is 18 years or older.
- Ability to understand and sign the informed consent prior to starting the study.
- Ability and willingness to comply with all study requirements.
- Adequate oral hygiene (defined as an average Modified Sulcus Bleeding Index of 1 or less and an average Modified Plaque Index of 1 or less).
- Must be a bounded edentulous space.
- Adequate bone volume to accommodate the planned endosseous dental implant (e.g. sufficient height such that the implant would not encroach on vital structures such as inferior alveolar nerve, and sufficient width that the implant could be placed within the confines of the existing bone without dehiscence or fenestration, requiring significant grafting at time of implant placement). The only implant utilized in this protocol will be a 4.0 mm diameter by 11 mm long implant (Fixture OsseoSpeed Astra Tech).
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- Typically, this will mean space dimensions will be: 6 mm or greater ridge width facial-lingual and > 6 mm in the mesial to distal dimension . If the implant can be placed and only a few screw threads are exposed, grafting is allowed to cover these threads. In the planned occlusal-gingival dimension, there must be at least 7 mm of space from the planned head of the implant to the planned occlusal plane.
- Osteotome use will be allowed but there must be a minimum of 8mm of bone height from the alveolar crest to the floor of the sinus. Maximum sinus lift will be 4 mm.
- Existing teeth are healthy and adequately restored, and desired a fixed restoration on implants.
- Patient has a mutually protected occlusion.
- The patient, if of childbearing potential, had a negative pregnancy test within one week prior to surgery.
Who cannot join
- Patients who have smoked cigarettes or chewed tobacco within the past year.
- History of alcoholism or drug abuse within the past 5 years. - Severe bruxing or clenching habits
- Untreated periodontitis
- Patients at undue risk for an outpatient surgical procedure
- Presence of residual roots at the implant site- Patients with history of site development (extensive bone augmentation) at the implant site in the past 4 months.
- Placement of implant in an extraction site that had been healing for less than 2 month.
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- Presence of local inflammation or mucosal diseases such as lichen planus.
- Uncontrolled diabetes (defined as HA1c > 7.0 percent).
- Current hematologic disorder or chronic use of coumarin (or similar) anti-coagulant therapies.
- History of leukocyte dysfunction and deficiencies
- Metabolic bone disorders
- History of renal failure
- History of liver disease
- Immunocompromised patients having HIV, RA, SLE or other collagen vascular disorders.
- Chronic corticosteroid use.
- Current chemotherapy
- History of use of IV-based bisphosphonates.
- History of radiation treatment to the head or neck
- Patients requiring grafting of bone or mucosal tissue at the time of implant placement which would require submersion of the implant during the healing period.
- Use of any investigational drug or device within the 30 day period immediately prior to implant surgery
- Patients requiring submersion of implants for esthetic reasons.
- Patient requiring ongoing dental treatment in the same quadrant or opposing quadrant during the initial 16 week healing period.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Iowa College of Dentistry
Iowa City, Iowa, 52242
About this study
Official title: the Effects of 3 Loading Protocols on Dental Implant Stability in Healed Ridges
This is a research study to test the clinical procedure and not the FDA approved medical device. This project will screen up to 80 volunteers to enroll 40 active subjects to receive a single tooth implant on an anterior (incisor/canine) or pre-molar tooth in the mandible or maxilla (no implants will be placed in molar sites). This 3 year research study will examine the clinical effects of loading regimens on roughened surfaced implants. The proposed research project will measure the changes in mucosal healing and maturation over a three year period following implant placement. The proposed research lays the foundation for improved health care by providing surgeons and restorative dentists with data for determining the relationship between implant healing, loading pattern and bone type. The rationale that underlies the investigation is that identification of the influences of timing of load on implant stability in varying bone types will allow routine, predictable use of early loading, which, in turn, will translate into more rapid health care, and improved psychosocial well-being of the patient. If these hypotheses are correct, these results are expected to provide evidence based research data to support early loading and immediate loading of single implants in sites of adequate bone volume, and density. In addition, it is expected that these results will fundamentally advance the field of implant dentistry and bioengineering by providing information on the principles of the bone density-mechanical environment-implant stability interaction.
Read the detailed description
MATERIALS AND METHODS This longitudinal human clinical trial is designed as a prospective study, to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement. After 16 weeks, a definitive implant abutment will be placed and a final dental crown delivered. No further follow-up will be done with the resonance frequency approach. However, all subjects will be followed through 3 years post implant placement as described for each follow-up visit. The study population consists of subjects at the University of Iowa's College of Dentistry. Subjects presenting with one tooth missing in the anterior (incisor/canine) or pre-molar regions of the mandible or maxilla with existing teeth that were healthy or adequately restored shall be screened based on the inclusion/exclusion criteria. The missing tooth is to be replaced with a fixed implant restoration on one implant.
SEQUENCE OF VISITS A. Visit 1: Screening Examination
Subjects shall be seen for evaluation and for collection of baseline data. Pre-treatment data shall be recorded on case report forms. The visit shall include:
- Explanation to the patient of the purposes of the study and the planned procedures related to the study.
- Explanation to the subject of the risks and possible complications of participation in the study. Patients shall be notified that inclusion in the study is for the purpose of providing implant treatment only and that no provision for other active treatments are guaranteed or implied except for care related to the implant aspect of their oral cavity. This treatment shall be agreed upon as outlined for their specific case.
Implant Site Selection: Adequate bone volume is needed to accommodate the planned endosseous dental implant. This will mean sufficient height such that the implant would not encroach on vital structures (such as inferior alveolar nerve), and sufficient width that the implant could be placed within the confines of the existing bone without dehiscence or fenestration, requiring significant grafting at time of implant placement. Typically, this will mean space dimensions will be: 6 mm or greater ridge width facial-lingual and > 6 mm in the mesial to distal dimension . If the implant can be placed and only a few screw threads are exposed, grafting is allowed to cover these threads. In the planned occlusal-gingival dimension, there must be at least 7 mm of space from the planned head of the implant to the planned occlusal plane.
The subject should be notified that inclusion in the study is conditional upon satisfying the inclusion and exclusion criteria as seen in Table 1. Only subjects satisfying the Inclusion/Exclusion criteria shall be enrolled.
The dental implant system to be used is the Astra Tech OsseoSpeed Dental Implant System (Astra Tech AB, Mölndal Sweden). This is an FDA cleared product under FDA 510k clearance act (FDA clearance 4/30/2004). This protocol calls for use of only the 4.0 mm diameter by 11 mm long dental implant (OsseoSpeed Aqua platform; Ref Number 24622; Astra Tech AB) in the anterior (incisor/canine) or posterior pre-molar regions of the mandible or maxilla. All sites must have sound natural or restored teeth/implants Mesial and Distal to the planned site of interest (Bounded Edentulous Space or BES). The patient should otherwise have a restored stable occlusion that is mutually protected. No implants will be placed in molar sites. The implant lengths accepted in the study are 11 mm. Clinical and radiographic screening will be used to limit the study to patients with sufficient bone quantity to completely encase the implant.
Upon review of the subject's health history, inclusion/exclusion criteria a screening clinical assessment will be made. Existing dental radiographs within the past 6 months shall be acceptable. No new radiographs will be made until subject enrollment and obtaining signed informed consent. The subject will be given an informed consent for the study and reviewed with the clinical study coordinator. Preliminary diagnostic impressions will made (Penta, 3M ESPE) and poured in dental stone (Whip Mix Corp., Louisville, KY). Implant subjects may have a pre-operative Cone Bean CT imaging study (Galileos; Sirona, Charlotte NC; www.sirona.com) made at the College of Dentistry's Department of Oral Maxillofacial Radiology at the discretion of the Principal Investigator following diagnostic work-up. Subjects shall be either patients of record of the College of Dentistry or shall be enrolled if new to the College. Patient records are electronic (WinDent) along with a paper version. Paper-based Case Report Forms (CRF) containing subject's medical information will be kept in one central file in a locked cabinet in the Dental Clinical Research Center. This data will be kept in a secured file accessible only by the PI and the Clinical Coordinator.
- Conditions
- Dental Implant
- Being tested
- dental implant
- Keywords
- dental implant, early loading, traditional loading, anterior, implant stability, Subjects presenting with one tooth missing in the anterior, incisor/canine) or pre-molar regions of the mandible, or maxilla with existing teeth that were healthy, or adequately restored shall be screened.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental implantDevice
Dental implant stability measured with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement.
| Study group | Role | What they receive |
|---|---|---|
| immediate load | Active comparator | immediate load of dental implant based on the bone quality determined by the insertion torque value Receives: Device: dental implant |
| Loading at 6 weeks | Active comparator | delayed load (6 weeks post surgery) of dental implants based on bone quality determined by the insertion torque value Receives: Device: dental implant |
| Loading at 12 weeks | Active comparator | traditional loading of dental implants (12 weeks post surgery) based on bone quality determined by the insertin torque value. Receives: Device: dental implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Stability Scale (ISQ) Score Change After 16 Weeks
The objective of this study is to examine the change in implant stability upon three different loading regimens during the first sixteen weeks following implant placement. ISQ score (1-100), where higher score equals more stability, was assessed. The main hypotheses of the study are 1) Implant stability (ISQ) is minimally affected when physiologic load is applied to an implant during the healing process.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2008 (estimated)
- Study startDec 2007
- Primary completionJun 2013
- Study completionJun 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 ImplantStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a phase IV Post-Market evaluation of three 510K cleared implant products. One type of dental implant was used but clinically loaded with a dental crown at one of three time points, immediate at implant placement, at 6weeks or 12 weeks following implant placement. There are therefore 3 interventions being evaluated.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clark Stanford
- Sponsor type
- University, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables
- Responsible party
- Sponsor-investigator, Clark Stanford, University of Iowa
- Investigators
- Clark Stanford, DDS, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607022
- Sponsor's protocol ID
- 200710722
- Status last verified
- Jul 2018
- First submitted
- 22 Jan 2008
- Last updated
- 27 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Primary data belongs to DENTSPLY-Sirona, the sponsor
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effects of 3 Loading Protocols on Dental Implant Stability in Healed Ridges
- ClinicalTrials.gov ID
- NCT00607022
- Acronym / sponsor ID
- 200710722
- Conditions
- Dental Implant
- Keywords
- dental implant, early loading, traditional loading, anterior, implant stability, Subjects presenting with one tooth missing in the anterior, incisor/canine) or pre-molar regions of the mandible, or maxilla with existing teeth that were healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Clark StanfordUniversity, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables
- Study start
- Dec 2007
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 5 Feb 2008 (estimated)
- Results
- Posted 27 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a research study to test the clinical procedure and not the FDA approved medical device. This project will screen up to 80 volunteers to enroll 40 active subjects to receive a single tooth implant on an anterior (incisor/canine) or pre-molar tooth in the mandible or maxilla (no implants will be placed in molar sites). This 3 year research study will examine the clinical effects of loading regimens on roughened surfaced implants. The proposed research project will measure the changes in mucosal healing and maturation over a three year period following implant placement. The proposed research lays the foundation for improved health care by providing surgeons and restorative dentists with data for determining the relationship between implant healing, loading pattern and bone type. The rationale that underlies the investigation is that identification of the influences of timing of load on implant stability in varying bone types will allow routine, predictable use of early loading, which, in turn, will translate into more rapid health care, and improved psychosocial well-being of the patient. If these hypotheses are correct, these results are expected to provide evidence based research data to support early loading and immediate loading of single implants in sites of adequate bone volume, and density. In addition, it is expected that these results will fundamentally advance the field of implant dentistry and bioengineering by providing information on the principles of the bone density-mechanical environment-implant stability interaction.
Detailed description
MATERIALS AND METHODS This longitudinal human clinical trial is designed as a prospective study, to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement. After 16 weeks, a definitive implant abutment will be placed and a final dental crown delivered. No further follow-up will be done with the resonance frequency approach. However, all subjects will be followed through 3 years post implant placement as described for each follow-up visit. The study population consists of subjects at the University of Iowa's College of Dentistry. Subjects presenting with one tooth missing in the anterior (incisor/canine) or pre-molar regions of the mandible or maxilla with existing teeth that were healthy or adequately restored shall be screened based on the inclusion/exclusion criteria. The missing tooth is to be replaced with a fixed implant restoration on one implant.
SEQUENCE OF VISITS A. Visit 1: Screening Examination
Subjects shall be seen for evaluation and for collection of baseline data. Pre-treatment data shall be recorded on case report forms. The visit shall include:
- Explanation to the patient of the purposes of the study and the planned procedures related to the study.
- Explanation to the subject of the risks and possible complications of participation in the study. Patients shall be notified that inclusion in the study is for the purpose of providing implant treatment only and that no provision for other active treatments are guaranteed or implied except for care related to the implant aspect of their oral cavity. This treatment shall be agreed upon as outlined for their specific case.
Implant Site Selection: Adequate bone volume is needed to accommodate the planned endosseous dental implant. This will mean sufficient height such that the implant would not encroach on vital structures (such as inferior alveolar nerve), and sufficient width that the implant could be placed within the confines of the existing bone without dehiscence or fenestration, requiring significant grafting at time of implant placement. Typically, this will mean space dimensions will be: 6 mm or greater ridge width facial-lingual and > 6 mm in the mesial to distal dimension . If the implant can be placed and only a few screw threads are exposed, grafting is allowed to cover these threads. In the planned occlusal-gingival dimension, there must be at least 7 mm of space from the planned head of the implant to the planned occlusal plane.
The subject should be notified that inclusion in the study is conditional upon satisfying the inclusion and exclusion criteria as seen in Table 1. Only subjects satisfying the Inclusion/Exclusion criteria shall be enrolled.
The dental implant system to be used is the Astra Tech OsseoSpeed Dental Implant System (Astra Tech AB, Mölndal Sweden). This is an FDA cleared product under FDA 510k clearance act (FDA clearance 4/30/2004). This protocol calls for use of only the 4.0 mm diameter by 11 mm long dental implant (OsseoSpeed Aqua platform; Ref Number 24622; Astra Tech AB) in the anterior (incisor/canine) or posterior pre-molar regions of the mandible or maxilla. All sites must have sound natural or restored teeth/implants Mesial and Distal to the planned site of interest (Bounded Edentulous Space or BES). The patient should otherwise have a restored stable occlusion that is mutually protected. No implants will be placed in molar sites. The implant lengths accepted in the study are 11 mm. Clinical and radiographic screening will be used to limit the study to patients with sufficient bone quantity to completely encase the implant.
Upon review of the subject's health history, inclusion/exclusion criteria a screening clinical assessment will be made. Existing dental radiographs within the past 6 months shall be acceptable. No new radiographs will be made until subject enrollment and obtaining signed informed consent. The subject will be given an informed consent for the study and reviewed with the clinical study coordinator. Preliminary diagnostic impressions will made (Penta, 3M ESPE) and poured in dental stone (Whip Mix Corp., Louisville, KY). Implant subjects may have a pre-operative Cone Bean CT imaging study (Galileos; Sirona, Charlotte NC; www.sirona.com) made at the College of Dentistry's Department of Oral Maxillofacial Radiology at the discretion of the Principal Investigator following diagnostic work-up. Subjects shall be either patients of record of the College of Dentistry or shall be enrolled if new to the College. Patient records are electronic (WinDent) along with a paper version. Paper-based Case Report Forms (CRF) containing subject's medical information will be kept in one central file in a locked cabinet in the Dental Clinical Research Center. This data will be kept in a secured file accessible only by the PI and the Clinical Coordinator.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a phase IV Post-Market evaluation of three 510K cleared implant products. One type of dental implant was used but clinically loaded with a dental crown at one of three time points, immediate at implant placement, at 6weeks or 12 weeks following implant placement. There are therefore 3 interventions being evaluated.
| Arm | Type | Receives |
|---|---|---|
| immediate load | Active comparator | Device: dental implantimmediate load of dental implant based on the bone quality determined by the insertion torque value |
| Loading at 6 weeks | Active comparator | Device: dental implantdelayed load (6 weeks post surgery) of dental implants based on bone quality determined by the insertion torque value |
| Loading at 12 weeks | Active comparator | Device: dental implanttraditional loading of dental implants (12 weeks post surgery) based on bone quality determined by the insertin torque value. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- The patient is 18 years or older.
- Ability to understand and sign the informed consent prior to starting the study.
- Ability and willingness to comply with all study requirements.
- Adequate oral hygiene (defined as an average Modified Sulcus Bleeding Index of 1 or less and an average Modified Plaque Index of 1 or less).
- Must be a bounded edentulous space.
Key exclusion criteria (22 listed)
- Patients who have smoked cigarettes or chewed tobacco within the past year.
- History of alcoholism or drug abuse within the past 5 years. - Severe bruxing or clenching habits
- Untreated periodontitis
- Patients at undue risk for an outpatient surgical procedure
- Presence of residual roots at the implant site- Patients with history of site development (extensive bone augmentation) at the implant site in the past 4 months.
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 stability measured with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement. | Device | Loading at 12 weeks, Loading at 6 weeks, immediate load |
Primary outcome
Implant Stability Scale (ISQ) Score Change After 16 Weeks
Time frame: 16 weeks
The objective of this study is to examine the change in implant stability upon three different loading regimens during the first sixteen weeks following implant placement. ISQ score (1-100), where higher score equals more stability, was assessed. The main hypotheses of the study are 1) Implant stability (ISQ) is minimally affected when physiologic load is applied to an implant during the healing process.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. Primary data belongs to DENTSPLY-Sirona, the sponsor
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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.
Clark Stanford, DDS, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dental implant in people with Dental Implant, run by Clark Stanford 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 11 inclusion and 22 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 27 Jul 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 27 Jul 2018). 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?
Implant Stability Scale (ISQ) Score Change After 16 Weeks (time frame: 16 weeks). 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 27 Jul 2018.