Periimplant Mucosa Dynamics Around Divergent and Concave Atlantis Abutment Transition Profiles
|ClinicalTrials.gov Identifier: NCT01871220|
Recruitment Status : Active, not recruiting
First Posted : June 6, 2013
Last Update Posted : February 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Dental Implant, Single-Tooth Esthetics, Dental||Device: Concave Transition Profile Device: Divergent Transition Profile||Not Applicable|
This is a randomized, prospective, controlled clinical trial comparing the facial gingival profiles around Atlantis™ abutments that have either a linear "divergent" or "concave" transitional profile on the facial and proximal aspect of the abutments.
Sixty study subjects requiring replacement of a single-rooted tooth with an implant-supported restoration will be recruited.
The Osseospeed™ Plus implant will be placed for all 60 subjects, with the use of Uni healing abutments to minimize lateral tissue displacement during healing. After implant placement, but before final impressions are obtained (8 weeks post-placement), subjects will be randomized to either a "divergent" or a "concave" transmucosal abutment design. For fabrication of the experimental abutment, Atlantis™ engineers will initially design a control "divergent" prototype that will be modified with a concavity on the facial and proximal transition zones to obtain an abutment that will otherwise retain all the features of the control abutment. Engineers will measure the linear topographical changes (ΔL=Lc-Ld) of the transition zone, as well as the volumetric change (x) on the mid-facial aspect of the abutment induced by the formation of a submucosal concavity. The primary outcome of the study will be the apico-coronal change of the peri-implant mucosal zenith from prosthesis delivery to one year.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2018|
Active Comparator: Divergent Abutment
Divergent Transition Profile
Device: Divergent Transition Profile
An Atlantis abutment is delivered with a linear transition profile
Experimental: Concave Abutment
Concave Transition Profile
Device: Concave Transition Profile
An Atlantis abutment is delivered with a concave transition profile.
- Peri-Implant Mucosal Zenith Changes [ Time Frame: 1, 3, 6, and 12 months ]Apico-coronal changes of the peri-implant mucosal zenith from prosthesis delivery to one year
- Comparison of bucco-linqual soft tissue thickness [ Time Frame: 1, 3, 6, and 12 months ]Submarginal bucco-lingual soft tissue thickness in the peri-implant transition zone relative to a fixed reference point.
- Quantification of the soft tissue interface [ Time Frame: 1, 3, 6, and 12 months ]Quantification of the topographical and volumetric features of the interface between the peri-implant mucosa and the transition zone.
- Keratinized mucosa width [ Time Frame: 1, 3, 6, and 12 months ]Keratinized mucosa width in an apicocoronal direction at the midfacial aspect of the implant site.
- Gingival and Plaque Index, Bleeding on Probing, and Probing Pocket Depths [ Time Frame: 1, 3, 6, and 12 months ]Gingival Index (GI), Plaque Index (PI), Bleeding on probing (BOP) and probing pocket depths (PPD) at six sites (disto-lingual, mesio-lingual, mid-lingual, mesio-buccal, disto-buccal, mid-buccal).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01871220
|United States, Iowa|
|University of Iowa College of Dentistry|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Chris A Barwacz, DDS||University of Iowa|