An interventional study of laser treated in Dental Implant Failed, sponsored by G. d'Annunzio University. Completed at 1 site in Italy. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-06.
Sponsored by G. d'Annunzio University · Not applicable, Interventional, and Treatment
The health of peri-implant soft tissues is important for the long-term success rate of dental implants and the surface topography is pivotal in influencing it. Thus, the aim of this study was to evaluate, in human patients, the inflammatory mucosal microenvironment in the tissue surrounding a new, nanoscale, laser-treated healing abutment characterized by engineered nanopores versus a standard machined-surface.
The prospective clinical study will evaluate the effect of the presence of a laser-etched surface in the coronal portion of healing stumps in forming the coronal seal and reducing the accumulation of bacterial plaque around it. The screws will serve as their own control group since they have both a laser-etched and a smooth portion.
Primary objective:
To evaluate the adhesion of fibroblastic cells from the peri-implant mucosa on the surface of the healing stump through scanning electron microscope analysis, expressed in terms of the area covered by the cells.
Secondary objectives:
To evaluate the amount of bacterial adhesion around healing stumps with a laser-etched and smooth altered surface through scanning electron microscope analysis, expressed in terms of the area covered by the cells.
To evaluate the presence of hemidesmosomal structures through the expression of α-6 and β-4 integrins.
To evaluate bacterial adhesion on healing screws. To evaluate the healing of peri-implant soft tissues through clinical indices, such as Plaque Index and Gingival Index.
The healing period was 12 ± 4 weeks (T1) before the second surgical procedure, during which all healing abutments were placed. To prevent allocation bias among patients, each healing abutment was designed with two surfaces that alternated between laser-treated/machined and ma-chined/laser-treated. The experimental healing abutment was removed after 30 ± 7 days, which coincided with the soft tissue biopsy.
G. d'Annunzio University is the lead sponsor of 66 studies on the registry; 21 are open to participants now.
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Exclusion Criteria:
on the same customized healing abutment laser-treated/machined surface treatments were repeated with the following order: Laser treated/machined/laser treated/machined. This order was performed to eliminate the bias of the different surface allocation on patients.
Procedure: laser treated
The second surgical stage was done after a healing period 12 ± 4 weeks (T1) where all the healing abutments were placed. Each healing abutment had repeated the two surfaces as twice follows: laser-treated/machined/ laser-treated/machined. Experimental healing abutment was removed after 30 ± 7 days, the same time as the soft tissue biopsy. After the healing period (30 ± 7 days), before starting with the prosthetic restoration of the fixtures, an impression was taken of the small-diameter Has, and circular sections (diameter 5 mm) soft tissues around them were retrieved for analysis.
soft tissue adhesion
To evaluate the adhesion of fibroblastic cells from the peri-implant mucosa on the surface of the healing stump through scanning electron microscope analysis, expressed in terms of the area covered by the cells.
Time frame: After a healing period of 12 ± 4 weeks, during the second surgical phase
bacterial adhesion
To evaluate the amount of bacterial adhesion around healing stumps with a laser-etched and smooth altered surface through scanning electron microscope analysis, expressed in terms of the area covered by the cells.
Time frame: After a healing period of 12 ± 4 weeks, during the second surgical phase
Plan to share: No
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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G. d'Annunzio University