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Clinical assessment of adhesive restorations in head and neck irradiated patients

Clinical assessment of the longevity of class V adhesive restorations in head and neck irradiated patients - randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-776sk7w
Enrollment
Unknown
Registered
2024-07-17
Start date
2023-11-01
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

Squamous Cell Carcinoma of Head and Neck

Interventions

This is a double-blind, controlled randomized clinical trial. In this investigation, 3 restorative materials (resin-modified glass ionomer cement, composite resin and composite resin with giomer techn
D05.750.716.822.308
D25.339.291.402

Sponsors

Faculdade de Odontologia da Universidade de São Paulo
Lead Sponsor
Faculdade de Odontologia da Universidade de São Paulo
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Individuals submitted to radiotherapy for head and neck cancer with the need and indication for class V restoration in at least one tooth; age 18 or above; both genders; and who agree to participate in the research by reading and signing the Informed Consent Form (ICF)

Exclusion criteria

Exclusion criteria: Individuals submitted to radiotherapy for head and neck cancer who have teeth in need of endodontic treatment or indirect restorations; individuals who do not wish to participate in the study

Design outcomes

Primary

MeasureTime frame
We expect to find similar results regarding the longevity of adhesive restorations over a 2-year period, confirmed by the absence of the need to replace the restoration, based on the normal distribution verified by the Shapiro-Wilk test and analysis by the three-criteria ANOVA test associated with Tukey's post-hoc test to verify the effect of the different materials, considering a significance level of 5%—

Secondary

MeasureTime frame
We expect to find similar results regarding the functional, biological and aesthetic properties of adhesive restorations over a 2-year period, according to the criteria recommended by the World Dental Federation (FDI), based on the normal distribution verified by the Shapiro-Wilk test and analysis by the three-criteria ANOVA test associated with Tukey's post-hoc test to verify the effect of the different materials, considering a significance level of 5%—

Countries

Brazil

Contacts

Public ContactGabriela Melo

Faculdade de Odontologia da Universidade de São Paulo

gabriela.banacu.melo@usp.br+55-11-30911000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)