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How to prevent Tooth Decay and Mouth Sores during Cancer treatment: the role of public universities in health and education

Prevention of Radiation Caries and Oral Mucositis in Cancer Patients: the transformative role of public universities in promoting health and education

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-426p272
Enrollment
Unknown
Registered
2025-09-22
Start date
2025-10-31
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

head and neck cancer

Interventions

This project is linked to an extension activity approved by PROEC (Financial Support through PROEC Call No. 06/2024) and is being conducted as a clinical research study in accordance with the CONSORT
Group 2, consisting of the basic protocol plus weekly fluoride mouthrinse (NaF 0.2%) and monthly application of fluoride varnish (2.26% F, Duraphat®, Colgate)
and Group 3, consisting of the basic protocol plus weekly fluoride mouthrinse (NaF 0.2%) and monthly topical application of PRG Pro-Care Gel® (Shofu). Each group will include 20 patients (n=20/group)
N02.421.726.758

Sponsors

Faculdade de Odontologia de Araraquara da Universidade Estadual Paulista (UNESP)
Lead Sponsor
Santa Casa de Araraquara
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adults (aged 18 years or older); diagnosis of cancer in the head and neck region; indication for radiotherapy in this region, scheduled to begin within 20 days after recruitment, with or without concomitant chemotherapy; ability to understand and communicate in order to respond to questionnaires and adhere to the protocol; signed informed consent form (ICF).

Exclusion criteria

Exclusion criteria: History of previous radiotherapy in the head and neck region; allergy to any of the components of the products to be provided; participants with severe systemic complications, decompensated and unfit to receive the preventive protocols during treatment (e.g., degenerative neurological diseases, terminal conditions); completely edentulous participants; pregnant or breastfeeding women.

Design outcomes

Primary

MeasureTime frame
To assess the incidence and/or prevalence of radiation caries using the ICDAS index, based on literature data indicating that 90% of patients develop caries due to radiotherapy. To assess the incidence and severity of oral mucositis using the Oral Mucositis Assessment Scale (OMAS), as almost 100% of patients experience ulcers.—

Secondary

MeasureTime frame
To assess the quality of life related to oral health using the OHIP-14 scale, since most patients report a worsening of their lives during cancer treatment.—

Countries

Brazil

Contacts

Public ContactBianca Nepomuceno Luchesi

Faculdade de Odontologia de Araraquara da Universidade Estadual Paulista (UNESP)

bianca.luchesi@unesp.br+551633316558

Outcome results

None listed

Source: REBEC (via WHO ICTRP)