OsseoSpeed™
DeviceOsseoSpeed™ implant
NCT Number: NCT00820235
The primary objective is to compare the gum response to three different dental implant designs when placed in the front region of the upper jaw. The changes from baseline to one year after will be compared. The null-hypothesis is that the buccal soft tissue (gum) changes from baseline to one year after are equal for all three implant-abutment interface settings.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Faculty of Dentistry, McGill University, Montreal, Quebec, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
The following should be considered at inclusion but can not be fulfilled until at Visit 2:
Exclusion criteria
OsseoSpeed™ implant
NobelSpeedy™ Replace® implant
NanoTite™ Certain® PREVAIL® implant
Time frame: Evaluated at time of loading (permanent restoration) and at the 5-years follow-up after loading
Soft tissue response was evaluated by measuring it clinically and by evaluating it from clinical photographs using image analysis. Clinical evaluations of gingival zenith were performed at time of loading (permanent restoration) and at the 5-year follow-up after loading.
The vertical distance from the most apical aspect of the soft tissue margin to the incisal edge of implant crown was measured using a standardized periodontal probe to the nearest half millimeter using the surgical loupe. The changes in the gingival zenith was calculated for each study position and the average for each treatment group was calculated for the evaluation period.
Time frame: Evaluated at time of implant installation and at the 5-year follow-up visit.
Marginal Bone Level determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal Bone Level expressed in millimeters at the 5-year follow-up visit compared to values obtained at time of implant placement.
Time frame: Measured at time of loading of permanent restoration and at the 5-year follow-up.
Condition of the periimplant mucosa by assessment of probing pocket depth (PPD).
Change in pocket depth expressed in millimeters at the 5-year follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline).
Negative value = increased pocket depth.
Time frame: Measured at the implant loading and at the 5-year follow-up after loading.
Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as change in proportion of surfaces that show presence of BoP, measured from implant loading to the 5-year follow-up visit.
Dentsply Sirona Implants and Consumables
Industry
Prospective, Comparative Assessment of Single-tooth Replacement in Different Implant-abutment Settings
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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