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

This study has been completed.
Sponsor:
Collaborator:
Dentsply Implants
Information provided by (Responsible Party):
Clark Stanford, University of Iowa
ClinicalTrials.gov Identifier:
NCT00607022
First received: January 22, 2008
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Dental Implant
Device: dental implant
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: the Effects of 3 Loading Protocols on Dental Implant Stability in Healed Ridges

Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • The objective of this study is to allow a preliminary analysis of the resonance frequency values over the 16 week period, which will be the primary outcome. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary measures of implant success (rotational movement, implant failure) will also be considered in this regard. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: December 2007
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
immediate load of dental implant based on the bone quality determined by the insertion torque value
Device: dental implant
This longitudinal human clinical trial is designed 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. delivered. No further follow-up will be done with the resonance frequency approach.
Other Names:
  • The implant in this protocol is
  • a 4.0 mm diameter by 11 mm long implant (Fixture OsseoSpeed Astra Tech).
Active Comparator: 2
delayed load (6 weeks post surgery) of dental implants based on bone quality determined by the insertion torque value
Device: dental implant
This longitudinal human clinical trial is designed 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. delivered. No further follow-up will be done with the resonance frequency approach.
Other Names:
  • The implant in this protocol is
  • a 4.0 mm diameter by 11 mm long implant (Fixture OsseoSpeed Astra Tech).
Active Comparator: 3
traditional loading of dental implants (12 weeks post surgery) based on bone quality determined by the insertin torque value.
Device: dental implant
This longitudinal human clinical trial is designed 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. delivered. No further follow-up will be done with the resonance frequency approach.
Other Names:
  • The implant in this protocol is
  • a 4.0 mm diameter by 11 mm long implant (Fixture OsseoSpeed Astra Tech).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607022

Locations
United States, Iowa
The University of Iowa College of Dentistry
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Dentsply Implants
Investigators
Principal Investigator: Clark Stanford, DDS, PhD The University of Iowa
  More Information

No publications provided

Responsible Party: Clark Stanford, Associate Dean for Research & Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT00607022     History of Changes
Other Study ID Numbers: D-2003-03
Study First Received: January 22, 2008
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
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.

ClinicalTrials.gov processed this record on September 22, 2014