Clinical, Prospective, Non-profit, Non-pharmacological Study on Geass Healing Abutment: Microbiological, Histological, and Immuno-histochemical Evaluation.
Condition: Dental Implant Failed
Study type: Interventional

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.
    


Intervention name(s): laser treated
Intervention type(s): Procedure
Intervention description(s): 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.
Intervention model: Single Group Assignment
Intervention model description: 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.
Masking: None (Open Label)
Primary purpose: Treatment