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

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.

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Key information

Conditions

Dental Implant Failed

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

G. d'Annunzio University

Chieti, CH, 66100, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients between 18 and 75 years
Patients with no systemic and/or oral health disease
At least six months of healing after tooth extraction
Adequate dimension of the attached gingiva (>2 mm) or keratinized tissue at the site selected and adequate residual bone crest

Exclusion criteria

- Patients with poor oral hygiene
Plaque score (PS) and bleeding on probing (BOP) more than 25%
Patients with active periodontal disease
Insufficient bone thickness for implant insertion and bone augmentation procedures
patients who necessitate immediate implant loading protocols
Uncontrolled diabetes mellitus
Immune diseases
Patients who smoke more than 10 cig/die

Treatment and study plan

laser treated

Procedure

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.

Primary outcomes

soft tissue adhesion

Time frame: After a healing period of 12 ± 4 weeks, during the second surgical phase

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 outcomes

bacterial adhesion

Time frame: After a healing period of 12 ± 4 weeks, during the second surgical phase

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.

Sponsors and collaborators

Lead sponsor

G. d'Annunzio University

Other

Registry information

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2020
First posted: Mar 6, 2023
Registry last updated: Mar 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed