A Randomized Prospective Clinical Trial Comparing Single Tooth Implant 3 Loading Protocols

Completed · Not applicable

Conditions studied: Dental Implant

In brief

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.

Key facts

Study ID

NCT00607022

Run by

Clark Stanford

People needed

41

Starts

2007-12-01

Expected to finish

2013-06-01

Last updated by the study team

2018-07-27

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• The University of Iowa College of Dentistry — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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