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

NCT00607022 | Completed Results DMC

• 1 other identifier: 200710722
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

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; or adequately restored shall be screened.

Outcome Measures

Primary Outcomes (1)

• 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.

  16 weeks

Study Arms (3)

immediate load

ACTIVE COMPARATOR

immediate load of dental implant based on the bone quality determined by the insertion torque value

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

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.

Device: dental implant

Interventions

dental implant DEVICE

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.

Loading at 12 weeks; Loading at 6 weeks; immediate load

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Clark Stanford: lead
• Dentsply Sirona Implants and Consumables: collaborator

Study Sites (1)

The University of Iowa College of Dentistry

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Interventions

Dental Implants

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Clark Stanford
• Organization: University of Iowa

CStanford@uiowa.edu

319-335-7381

Study Officials

• Clark Stanford, DDS, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Dean for Research & Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 22, 2008
• First Posted: February 5, 2008
• Study Start: December 1, 2007
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 27, 2018
• Results First Posted: July 27, 2018

Record last verified: 2018-07

Locations

US (1)