Clinical, Prospective, Non-profit, Non-pharmacological Study on Geass

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Dental Implant Failed

Clinical Trial Details

NCT number	NCT05754970
Study type	Interventional
Source	G. d'Annunzio University
Contact
Status	Completed
Phase	N/A
Start date	November 1, 2018
Completion date	January 15, 2020

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical, Prospective, Non-profit, Non-pharmacological Study on Geass Healing Abutment: Microbiological, Histological, and Immuno-histochemical Evaluation.

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms