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

NCT05754970 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2023-03-06

No results posted yet for this study

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.

Conditions

  • Dental Implant Failed

Interventions

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.

Sponsors & Collaborators

  • G. d'Annunzio University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2019-02-01
Completion
2020-01-15

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05754970 on ClinicalTrials.gov