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The purpose of the study is to compare two different types of dental implants which will be used to support/retain a removable denture in the edentulous mandible. Subjects will have one implant placed in the midline of the mandible after which the patient's existing denture will be modified to fit the implant. The population of this study consists of healthy edentulous individuals 20-75 years of age who have complete dentures in the upper and lower arch.
Titanium dental implants have been frequently used in the rehabilitation of edentulous patients. Implants may provide adequate denture stability, improve oral function and oral health related quality of life. There is evidence that implants supporting fixed and removable prostheses have excellent long term success rates. Factors such as implant surface characteristics, length, diameter and shape (parallel sided or tapered) may play and important role for the outcome of the treatment especially when the immediate loading protocol (loading of the implant the same day it is surgically placed) is utilized. There are reports indicating that dental implants placed according to the immediate loading protocol can be used to support removable prostheses in the mandible. Such protocol would minimize the number of surgical procedures and significantly shorten the overall treatment time. Further, increased oral health related quality of life has been reported from studies on mandibular implant overdentures. Traditionally two implants have been suggested for the support of a mandibular overdenture. However, high patient satisfaction rates and appropriate denture retention have been reported among patients with a single implant placed in the mid-line. It is also important to further evaluate and compare various implant designs to determine clinical outcomes. The two dominating types of implant body design on the market are the parallel-sided (straight) and the tapered (conical) shaped. Both implants have similar threads, and the surgical procedure for placing the implants in the bone tissue is similar, but the drills used have a slightly different design and shape. There are today no randomized controlled studies evaluating differences in outcomes with respect to the external implant design i.e. parallel sided or tapered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parallel sided implant Group | Active Comparator | A Parallel sided titanium dental implant will be placed in the edentulous mandible. |
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| Tapered shaped implant Group | Active Comparator | A tapered shaped titanium dental implant will be placed in the edentulous mandible. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nobel Biocare titanium dental implants | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Difference in Implant Failure Rate Between Parallel Sided and Tapered Dental Implants at 5 Years | Implant failure defined as an implant that has lost osseointegration and no longer is stable and supported by the surrounding bone (no bone to implant contact). | From implant placement (baseline) to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Implant Stability Quotient (ISQ) Measured at 5 Years | The implant stability quotient (ISQ) value is a measurement of the mechanical implant stability in the bone and is measured directly after surgical implant placement and then at follow-ups. It is obtained by resonance frequency with a device that sends out a signal to a metal rod placed in the implant and then reads the value of the signal when it bounces back. The value ranges from 0 to 100 with higher values indicating better bone-to-implant contact and greater stability. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mats Kronstrom, DDS, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Regional Research Clinic, School of Dentistry at the University of Washington | Seattle | Washington | 98025 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28095527 | Background | Kronstrom M, Davis B, Loney R, Gerrow J, Hollender L. Satisfaction and Clinical Outcomes Among Patients with Immediately Loaded Mandibular Overdentures Supported by One or Two Dental Implants: Results of a 5-Year Prospective Randomized Clinical Trial. Int J Oral Maxillofac Implants. 2017 Jan/Feb;32(1):128-136. doi: 10.11607/jomi.4824. |
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Individual Participant Data (IPD) will not be shared with other researchers
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Of 48 eligible participants who signed the consent form and were enrolled in the study, one declined study participation due to lack of willingness to pay for the required cone beam computed tomography (CBCT) pre-surgical procedure. Participants were randomized to implant group the day of surgery.
Participants were recruited via flyers posted in the School of Dentistry. A total of 63 people were screened for eligibility and 48 met the inclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Parallel Sided Implant Group | A Parallel sided titanium dental implant will be placed in the edentulous mandible. Nobel Biocare titanium dental implants |
| FG001 | Tapered Shaped Implant Group | A tapered shaped titanium dental implant will be placed in the edentulous mandible. Nobel Biocare titanium dental implants |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Parallel Sided Implant Group | A Parallel sided titanium dental implant will be placed in the edentulous mandible. Nobel Biocare titanium dental implants |
| BG001 | Tapered Shaped Implant Group |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Difference in Implant Failure Rate Between Parallel Sided and Tapered Dental Implants at 5 Years | Implant failure defined as an implant that has lost osseointegration and no longer is stable and supported by the surrounding bone (no bone to implant contact). | All participants who had an implant placed at the midline of the mandibular arch and their mandibular denture fitted for immediate wearing. | Posted | Count of Participants | Participants | From implant placement (baseline) to 5 years |
|
5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Parallel Sided Implant Group | A Parallel sided titanium dental implant will be placed in the edentulous mandible. Nobel Biocare titanium dental implants |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant failure | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mats Kronstrom | University of Washington | 425-877-7345 | mk33@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 18, 2012 | Dec 18, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 14, 2023 | Dec 18, 2023 | SAP_001.pdf |
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| 5 years |
| Bone Loss Measurement at 5 Years | The measure of bone loss in millimeters (mm) around the implant at 5 years compared to bone height at baseline. Changes in bone level are measured on intraoral radiographs and compared with the bone level measure immediately after surgical implant placement (baseline). The implant platform was used as the reference point and measurements of the bone were made to the nearest thread. The bone level is measured on both sides (mesial & distal) of the implant using the thread on the implant as reference. The distance between the threads is 0.6 mm. | From implant placement (baseline) to 5 years |
| Deceased |
|
| Failed implant |
|
A tapered shaped titanium dental implant will be placed in the edentulous mandible.
Nobel Biocare titanium dental implants
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Implant stability quotient (ISQ) | The ISQ is obtained by resonance frequency measurement after an implant is placed. The value of the measurement ranges from 1 to 100 with higher values indicating greater stability. | Mean | Standard Deviation | units on a scale |
|
A tapered shaped titanium dental implant will be placed in the edentulous mandible. Nobel Biocare titanium dental implants |
|
|
|
| Secondary | Implant Stability Quotient (ISQ) Measured at 5 Years | The implant stability quotient (ISQ) value is a measurement of the mechanical implant stability in the bone and is measured directly after surgical implant placement and then at follow-ups. It is obtained by resonance frequency with a device that sends out a signal to a metal rod placed in the implant and then reads the value of the signal when it bounces back. The value ranges from 0 to 100 with higher values indicating better bone-to-implant contact and greater stability. | Participants continuing in the study at 5 years | Posted | Mean | Standard Deviation | units on a scale | 5 years |
|
|
|
|
| Secondary | Bone Loss Measurement at 5 Years | The measure of bone loss in millimeters (mm) around the implant at 5 years compared to bone height at baseline. Changes in bone level are measured on intraoral radiographs and compared with the bone level measure immediately after surgical implant placement (baseline). The implant platform was used as the reference point and measurements of the bone were made to the nearest thread. The bone level is measured on both sides (mesial & distal) of the implant using the thread on the implant as reference. The distance between the threads is 0.6 mm. | Participants continuing in the study at 5 years | Posted | Mean | Standard Deviation | millimeters | From implant placement (baseline) to 5 years |
|
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|
|
| 1 |
| 24 |
| 0 |
| 24 |
| 2 |
| 24 |
| EG001 | Tapered Shaped Implant Group | A tapered shaped titanium dental implant will be placed in the edentulous mandible. Nobel Biocare titanium dental implants | 1 | 23 | 0 | 23 | 2 | 23 |
| Participant wanted implant removed | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
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