A Randomized Prospective Clinical Trial Comparing Single Tooth Implant 3 Loading Protocols (NCT00607022) | Clinical Trial Compass
CompletedNot Applicable
A Randomized Prospective Clinical Trial Comparing Single Tooth Implant 3 Loading Protocols
United States41 participantsStarted 2007-12
Plain-language 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 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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).
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Implant Stability Scale (ISQ) Score Change After 16 Weeks