Ghent University
Ghent, 9000, Belgium
NCT Number: NCT01620918
* Baseline:
* Standard preparation of the osteotomy * Placement of 2 dental implants * On each implant one of both types of healing abutments is placed * Suturing * Standardized radiography to measure bone-levels at baseline * Digital impression of the surrounding gingiva with an intra-oral scanner (a non-invasive method) to measure the baseline level of the gingiva * 2 weeks after Baseline:
o Removal of the sutures * 4 weeks after Baseline:
* A 2nd digital impression of the soft tissue with an intra-oral scanner * Collecting crevicular fluid by placing paperpoints in the provided apertures in the healing abutments for 60 seconds without bleeding. * Measuring of the pocket depth in the provided apertures in the healing abutments with an automated probe. * Removal of the Healing Abutment with the attached soft tissue en-bloque. * Placement of a new, regular, Encode Healing Abutment. * 10 weeks after Baseline:
* Start of standard prosthetic procedure. In this study we expect that the soft tissue attachment (i.e. the gingival attachment) will be stronger and earlier achieved at the nano-structured healing abutments than at the normal, uncoated healing abutments. This would lead to a more stable soft tissue complex on the long rung and thus providing a more predictable aesthetic outcome. Secondly, a stronger attachment would mean a stronger barrier against micro-organisms and might influence the occurrence of peri-implantitis.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Ghent, 9000, Belgium
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patient receives the normal, uncoated healing abutment on 1 of his (minimal 2) dental implants.
Patient receives the nano-structured healing abutment on 1 of his (minimal 2) dental implants.
Time frame: at 4 weeks post-implantation
Genetic evaluation (through Polymerase Chain Reaction, PCR, the tissue will be detected for certain growth factors), histomorphometric analysis to measure the actual percentage of the surface on which the gingiva is attached to, clinical evaluation of the strength of the attachment through means of an automated probe.
University Ghent
Other
Acronym: STRANDI
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