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

Dental Implant Failed Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05754970
• Other study ID #: 2218102018
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: January 15, 2020

Study information

• Verified date: February 2023
• Source: G. d'Annunzio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 15, 2020
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Implant Failed

Intervention

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.

Locations

Country	Name	City	State
Italy	G. d'Annunzio University	Chieti	CH

Sponsors (1)

Lead Sponsor	Collaborator
G. d'Annunzio University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	After a healing period of 12 ± 4 weeks, during the second surgical phase
Secondary	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.	After a healing period of 12 ± 4 weeks, during the second surgical phase