Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to assess the change of crestal bone level at the Titanium Zirconium (TiZr) compared to Titanium (grade IV) implant between surgery and 6, 12, 24, and 36 month post surgery.


Clinical Trial Description

This is a clinical trial to compare crestal bone level changes, soft tissue parameters, implant success and survival between small diameter implants in edentulous mandibles restored with removable overdentures.

An initial patient evaluation will be conducted to determine wether a patient meets the study inclusion and exclusion criteria.

The edentulous subjects will undergo surgery for placement of two dental implants, the test and control implant. The implants will be placed in the intraforaminal region.

A gingival former will be inserted in the implant after implant placement to ensures a transmucosal healing. After 6 to 8 weeks the healing abutments will be retrieved and the locator abutments will be connected to the implant.

The removable prosthesis will be prepared and connected to the implants two weeks later.

The study will be blinded until 12 month post surgery and completed with an unblinded follow up period up to 3 years.

Straumann will deliver the randomization envelopes to the sites which had been created by an independent Clinical Research Organization (CRO). The randomization envelopes are marked with a sequential number. The master randomization list will be kept at Straumann.

The success and survival of the implants, soft tissue conditions, success of the prosthesis part and product safety will be assessed after 6, 12, 24, and 36 month after surgery.

Source data verification will be performed by qualified study monitors to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources.

Data will be recorded on standardized Case Report Forms for all study subjects from whom informed consent is obtained. The investigator will be responsible for the accuracy of the data entered on the Case Report Forms. All source documents pertaining to this study will be maintained by the investigator and made available for inspection by authorized persons.

Sample size calculations are proceeded for a given range of clinical relevant differences between test and control implant and a given range of standard deviations with the two sided paired t-test under a significance level of 0.05 and with a power of 80 percent.

To be robust against deviations from the assumption of normality and to take into account possible dropouts it is good clinical practice to increase the calculated sample size by about 10 to 20 percent.

To detect a clinical relevant difference down to 0.1 with a standard deviation of 0.3, one needs 73 plus 15 (88) patients for the study.

Management of dropouts and missing data will depend on their frequency and the particular outcome measure. Any such adjustments will be described completely. All data will be included in the analysis. If outliers are determined to exist, an additional analysis excluding such outliers may be performed and the rationale for such exclusion will be described completely.

A first data analysis including data up to 12 month after surgery is planned after all patients have completed the respective study period. Inferential statistical analysis at this stage will be restricted to the primary efficacy parameter. The final data analysis will be performed after all patients have completed the study.

Categorical data will be described as contingency tables with frequencies and percentage, whereby the dominator for percentages is defined as the number of patients in the respective analysis set. Continuous data will be summarised by mean, standard deviation, minimum, 1st quartile, median, 3rd quartile and maximum. Also the number of missing and nonmissing values will be given.

Tables will be presented by device type and or total, as appropriate. Preabutment connection values will serve as baseline values. Hypothesis tests will be carried out at a two sided significance level of 5 percent, except for the primary efficacy analysis. The confirmatory noninferiority test will be performed at a one sided 2.5 percent significance level.

As usual for secondary, no adjustment os significance level for multiple testing will be performed.

In case of unacceptable deviations from the statistical model assumption, transformations of the data, the use of different distributional models or nonparametric approaches will be considered.

All statistical calculations and analyses will be performed using the Statistical Analysis System (SAS) version 9.1.13 or higher. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00905840
Study type Interventional
Source Institut Straumann AG
Contact
Status Completed
Phase N/A
Start date November 2007
Completion date September 2011

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05355792 - Multicenter Study to Evaluate the Clinical Outcome of the OmniTaper EV Implant in Single Tooth Restorations N/A
Terminated NCT00748670 - Treatment With Fixture Microthread™ in Patients With Poor Bone Quality and no Teeth in the Upper Jaw, When Using Two-Stage Surgery N/A
Completed NCT04873219 - Milled Versus Printed CAD/CAM Complete Dentures N/A
Active, not recruiting NCT04545840 - Prospective Neodent® Zirconia System Study
Completed NCT00922935 - Comparison of Early and Late Loading in the Edentulous Upper Jaw Using Cresco Prosthetic System on Straumann Implants Phase 4
Completed NCT00959530 - Comparison of Lingualized and Full Bilaterally Balanced Articulation N/A
Completed NCT00711022 - Study on ASTRA TECH Implant System, OsseoSpeed™ Implants in Patients Missing All Teeth in the Upper Jaw, Restored With Provisional Teeth Within 24 Hours N/A
Terminated NCT00295126 - REPI : a Randomized Open Label Trial Evaluating the Use of APC in Pre-Implantation Reconstruction of Maxilla Phase 2/Phase 3
Recruiting NCT03957265 - Prospective Observational Study of SynCone® Concept Phase 1
Completed NCT01909999 - Release of Osteogenic Markers in Immediately and Non-loaded Dental Implants N/A
Completed NCT00901017 - Comparison of Synthetic Bone Substitute and a Bovine-derived Xenograft in Horizontal Bone Augmentation N/A
Completed NCT01641198 - An Implant With an Acid-etched Fixture Surface and Internal-hex Collar May Achieve Greater Osseointegration. N/A
Completed NCT03862482 - Peri-Implant Healing Around Two Different Machined-Collar Designs After 25 Years of Function N/A
Completed NCT01878331 - Long-term Study to Evaluate Different Dental Implant Alloys in Straumann 3.3mm Diameter Bone Level Implants
Completed NCT02418117 - Accuracy of Computer Guided Implant Surgery N/A
Completed NCT02107612 - Randomized Study For Minimally Invasive Splinted Implants N/A
Active, not recruiting NCT05007691 - Comparative Study of Maxillary and Mandibular Splints Used for the Treatment of Masticatory Muscle Parafunction (FEA) N/A
Active, not recruiting NCT04328116 - Study of Neodent Implantable Devices of GM Zygomatic Line
Active, not recruiting NCT05032170 - Intraoral Scanning Accuracy in the Edentulous Mandible
Completed NCT05709236 - Digital Versus Conventional Full-arch Implant Impression in Maxillary Screw- Retained Implant Prosthesis N/A