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

NCT ID: NCT05754970

Last Updated: 2023-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2020-01-15

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

laser/machined

on the same customized healing abutment laser-treated/machined surface treatments were repeated with the following order: Laser treated/machined/laser treated/machined. This order was performed to eliminate the bias of the different surface allocation on patients.

Group Type: EXPERIMENTAL

laser treated

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

G. d'Annunzio University

OTHER

Sponsor Role: lead

Responsible Party

Michele Paolantonio

Full Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

G. d'Annunzio University

Chieti, CH, Italy

Countries

Italy

References

Belloni A, Argentieri G, Orilisi G, Notarstefano V, Giorgini E, D'Addazio G, Orsini G, Caputi S, Sinjari B. New insights on collagen structural organization and spatial distribution around dental implants: a comparison between machined and laser-treated surfaces. J Transl Med. 2024 Jan 31;22(1):120. doi: 10.1186/s12967-024-04906-4.

Reference Type: DERIVED

PMID: 38297308 (View on PubMed)

Gaggi G, Di Credico A, D'Addazio G, Ghinassi B, Argentieri G, Caputi S, Di Baldassarre A, Sinjari B. Impact on peri-implant connective tissue of laser treated versus traditional healing abutments: a human clinical trials. BMC Oral Health. 2023 Jun 27;23(1):425. doi: 10.1186/s12903-023-03148-y.

Reference Type: DERIVED

PMID: 37370064 (View on PubMed)

Other Identifiers

2218102018

Identifier Type: -

Identifier Source: org_study_id