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

NCT05754970 | Completed

• 1 other identifier: 2218102018
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• bacterial adhesion

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

Study Arms (1)

laser/machined

EXPERIMENTAL

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.

Procedure: laser treated

Interventions

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.

laser/machined

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• G. d'Annunzio University: lead

Study Sites (1)

G. d'Annunzio University

Chieti, CH, 66100, Italy

Location

Related Publications (2)

• 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.

  PMID: 38297308 DERIVED

• 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.

  PMID: 37370064 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 6, 2023
• Study Start: November 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: January 15, 2020
• Last Updated: March 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)