Study Comparing Appearance and Function of Three Different Dental Implant Designs When Placed in Front Region of Upper Jaw
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|ClinicalTrials.gov Identifier: NCT00820235|
Recruitment Status : Completed
First Posted : January 12, 2009
Results First Posted : May 7, 2020
Last Update Posted : May 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Jaw, Edentulous, Partially||Device: OsseoSpeed™ Device: NobelSpeedy™ Replace® Device: NanoTite™ Certain® PREVAIL®||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||141 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective, Comparative Assessment of Single-tooth Replacement in Different Implant-abutment Settings|
|Actual Study Start Date :||February 2009|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2016|
|Active Comparator: B||
Device: NobelSpeedy™ Replace®
NobelSpeedy™ Replace® implant
|Active Comparator: C||
Device: NanoTite™ Certain® PREVAIL®
NanoTite™ Certain® PREVAIL® implant
- Buccal Soft Tissue (Gum) Changes, Measured as Mid-buccal Gingival Zenith (GZ) Scores. [ 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.
- Marginal Bone Level Alterations [ 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.
- Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD [ 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.
- Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in BoP. [ 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.
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): NCT00820235
|United States, Iowa|
|University of Iowa, College of Dentistry|
|Iowa City, Iowa, United States, 52242-1010|
|United States, North Carolina|
|University of North Carolina, School of Dentistry|
|Chapel Hill, North Carolina, United States, 27599-7450|
|United States, Texas|
|Perio Health Clinical Research Center|
|Houston, Texas, United States, 77063|
|Faculty of Dentistry, McGill University|
|Montreal, Quebec, Canada, H3A 2K6|
|Study Director:||Lyndon Cooper, Prof.||University of Illinois College of Dentistry|