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Evaluation of color change in Ceramic Laminate procedures - Clinical Trial

Evaluation of color change after application of an Adhesive on the inside of Ceramic Laminates - Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5fntkyv
Enrollment
Unknown
Registered
2023-01-12
Start date
2022-12-04
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Color

Interventions

66 restorations will be performed with ceramic laminates (n=66) of Lithium Disilicate, in 11 patients selected according to the inclusion and exclusion criteria of the study, the restorations will be
http://www.random.org). The study will be double blind masked. Randomization will be hidden by sealed, opaque, sequentially numbered envelopes, containing the cementation mode (with application of the

Sponsors

Universidade de São Paulo - Faculdade de Odontologia
Lead Sponsor
Dentscare LTDA
Collaborator

Eligibility

Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Individuals of both sexes; aged between 18 and 60 years; good general and oral health; absence of orthodontic appliances; absence of joint problems; absence of gingival recession on the buccal surface; absence of mandibular prognathism or maxillary retrognathism; willing to undergo radiographic examinations; and be willing to sign an informed consent.

Exclusion criteria

Exclusion criteria: Smokers; individuals with large restorations in the anterior region; dark colored teeth (VITA A3.5 and C4 shades); teeth with fluorosis; patients with gingivitis and/or periodontal diseases; teeth with severe gingival bleeding; poor oral hygiene; high rates of caries; history of allergy to any of the materials; pregnancy; use of medications known to interfere with the oral environment; systemic or malignancies; inability to undergo any study-specific techniques; lack of adequate vertical dimension of occlusion (OVD); lack of space for correct installation of laminates; and presence of parafunctional habits.

Design outcomes

Primary

MeasureTime frame
Restoration color change (from baseline to 24-month follow-up, every 6 months). Monitoring the color stability of lithium disilicate ceramic laminates up to 24 months by calculating the color difference (?Eab and ?E00), where the data will be obtained by two different methods of color analysis (spectrophotometry and photocolorimetry); it is expected that no unacceptable color change between the times, values of ?Eab<2.7 and ?E00<1.8 will be considered clinically acceptable.

Secondary

MeasureTime frame
Restoration longevity (from baseline to 24-month follow-up, every 6 months). Evaluation of the effect of using an adhesive system in the restoration with lithium disilicate ceramic laminates after silane application using the World Dental Federation (FDI) criteria; the treatment will be considered successful when they present a “clinically very good”, “clinically good” or “clinically sufficient” aspect and failures will be scored as “clinically unsatisfactory” and “clinically deficient”, that is, when there is a need for treatment. repair or replacement, a non-parametric analysis is expected to be applied.;Cementation thickness (After the laminates are cemented). Analysing the thickness of the resin cementation line formed between the substrate and the lithium disilicate ceramic laminate through images obtained by means of computed tomography (CT); this thickness is expected to be an average of 100 µm (±0.5) so it will not interfere the mechanical integrity of the restoration, increase polymerization stress and the chance of iatrogenic gingivitis, or influence color and translucency.;Interaction with the periodontium (from baseline to 24-month follow-up, every 6 months). Evaluation of the influence of cementation of lithium disilicate ceramic laminates on periodontal health by comparing periodontal measurements obtained from CT scans; it is expected to find a biological balance of the prosthetic/periodontal transition aiming at the success and longevity of the restorations.;Periodontal Changes (from baseline to 24-month follow-up, every 6 months). Analysing whether the cementation of ceramic laminates has the ability to generate periodontal changes through existing biomarkers in the gingival crevicular fluid (CGF) collected; it is expected that there is no difference in the cytokines found at all evaluation times.

Countries

Brazil

Contacts

Public ContactMylena Régis

Universidade de São Paulo - Faculdade de Odontologia

mylenaregis@usp.br+55 (83) 99327-3970

Outcome results

None listed

Source: REBEC (via WHO ICTRP)