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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00607022
Recruitment Status : Completed
First Posted : February 5, 2008
Results First Posted : July 27, 2018
Last Update Posted : July 27, 2018
Dentsply Sirona Implants
Information provided by (Responsible Party):
Clark Stanford, University of Iowa

Brief 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.

Condition or disease Intervention/treatment Phase
Dental Implant Device: dental implant Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: the Effects of 3 Loading Protocols on Dental Implant Stability in Healed Ridges
Study Start Date : December 2007
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Arm Intervention/treatment
Active Comparator: immediate load
immediate load of dental implant based on the bone quality determined by the insertion torque value
Device: dental implant
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.

Active Comparator: Loading at 6 weeks
delayed load (6 weeks post surgery) of dental implants based on bone quality determined by the insertion torque value
Device: dental implant
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.

Active Comparator: Loading at 12 weeks
traditional loading of dental implants (12 weeks post surgery) based on bone quality determined by the insertin torque value.
Device: dental implant
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.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00607022

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United States, Iowa
The University of Iowa College of Dentistry
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Clark Stanford
Dentsply Sirona Implants
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Principal Investigator: Clark Stanford, DDS, PhD University of Iowa
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Responsible Party: Clark Stanford, Associate Dean for Research & Professor, University of Iowa Identifier: NCT00607022    
Other Study ID Numbers: 200710722
First Posted: February 5, 2008    Key Record Dates
Results First Posted: July 27, 2018
Last Update Posted: July 27, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Primary data belongs to DENTSPLY-Sirona, the sponsor
Keywords provided by Clark Stanford, University of Iowa:
dental implant
early loading
traditional loading
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.