A Randomized Prospective Clinical Trial Comparing Single Tooth Implant 3 Loading Protocols
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ClinicalTrials.gov Identifier: NCT00607022 |
Recruitment Status :
Completed
First Posted : February 5, 2008
Results First Posted : July 27, 2018
Last Update Posted : July 27, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dental Implant | Device: dental implant | Not Applicable |

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
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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. |
- 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.

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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.

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 ClinicalTrials.gov identifier (NCT number): NCT00607022
United States, Iowa | |
The University of Iowa College of Dentistry | |
Iowa City, Iowa, United States, 52242 |
Principal Investigator: | Clark Stanford, DDS, PhD | University of Iowa |
Responsible Party: | Clark Stanford, Associate Dean for Research & Professor, University of Iowa |
ClinicalTrials.gov 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 |
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. |