Dental caries, unspecified.
Conditions
Interventions
This is a double-blind, controlled, randomized, split-mouth clinical study. A total of 49 people who meet the eligibility criteria will be probabilistically allocated to one or the other intervention
bioactive"
group, which characterizes the study as split-mouth. Neither the researchers who will evaluate the outcomes nor the participants will know which group each participant belongs to. Experimental group:
material Beautifil II from Shofu Inc. Control group: the same 49 people will also receive a direct dental restoration with the control material NeoSpectra from Dentsply Sirona. The restorations will b
Sponsors
Faculdade de Odontologia de Piracicaba - Universidade Estadual de Campinas
Instituto do Câncer do Estado de São Paulo - ICESP
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients who have undergone treatment for head and neck cancer (radiotherapy); both genders; over 18 years of age; have at least two carious cervical lesions; oral health consistent with the Simplified Oral Hygiene Index.
Exclusion criteria
Exclusion criteria: Patients with orthodontic appliances; those allergic to resin-based materials; those who have not undergone radiotherapy for head and neck cancer treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the ability of a bioactive composite containing S-PRG (Surface Pre Reacted Glass) fillers to prevent or control the development of recurrent caries around restorations. Assessment will be performed through clinical examination using the "World Dental Federation" (FDI) criteria and/or the modified United States Public Health Service (USPHS) criteria. Recurrent caries will be considered present when scores indicate changes in marginal adaptation, marginal staining, or restoration integrity consistent with clinical failure according to the cut-off points established in these criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected that the restorative composite containing S-PRG fillers will be able to prevent or control the development of recurrent caries around restorations, assessed through complementary clinical evaluation using the FDI criteria and/or the modified USPHS criteria. A favorable response will be defined as the maintenance or improvement of clinical scores related to marginal staining, marginal integrity, and structural integrity of the restorative material, as well as the absence of lesion progression throughout the follow-up period. | — |
Countries
Brazil
Contacts
Public ContactLuana Soares
Faculdade de Odontologia de Piracicaba - Universidade Estadual de Campinas
Outcome results
None listed