Treatment of cavities caused by radiotherapy in patients with a history of head and neck cancer using a new dental restorative material

Bioactive restorative system in radiation-related caries lesions in head and neck cancer survivors: a randomized controlled double-blind split-mouth clinical trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

REBEC

Registry ID

RBR-4cp3fbt

Enrollment

Registered

2026-05-11

Start date

2026-01-20

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Dental caries

Interventions

This is an interventional, controlled, randomized, prospective, double-blind clinical study with a split-mouth design, aiming to evaluate the clinical performance of two resin-based restorative system

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients aged over 18 years; previous diagnosis of head and neck cancer; survivors of the disease who have undergone radiotherapy; presence of paired primary cervical radiation-related caries lesions in the cervical region of incisors, canines, and premolars

Exclusion criteria

Exclusion criteria: Patients whose tumor site does not involve the head and neck region or who have not been treated with radiotherapy; patients presenting radiation-related caries lesions in single or non-homologous teeth; patients with known allergy to the main components of the materials used in this study; patients with grade 2 or higher trismus according to the adapted LENT SOMA scale (Carneiro et al., 2023); patients presenting asialia; and patients with active oncologic disease or recurrence involving areas adjacent to the teeth

Design outcomes

Primary

Measure	Time frame
It's expected to observe the clinical performance of restorations in primary radiation-related caries lesions assessed using the United States Public Health Service and the Fédération Dentaire Internationale criteria at 7 days, 3 months, and 6 months	—

Secondary

Measure	Time frame
It's expected to evaluate the occurrence of secondary caries and marginal adaptation in restorations performed with two resin-based restorative systems in primary radiation-related caries lesions, assessed using the United States Public Health Service and the Fédération Dentaire Internationale criteria at 7 days, 3 months, and 6 months;It's expected to observe the impact of the clinical performance of restorations in radiation-related caries lesions on patients’ quality of life, assessed using the Oral Health Impact Profile-14 (OHIP-14) at 7 days, 3 months, and 6 months	—

Measure

Time frame

It's expected to evaluate the occurrence of secondary caries and marginal adaptation in restorations performed with two resin-based restorative systems in primary radiation-related caries lesions, assessed using the United States Public Health Service and the Fédération Dentaire Internationale criteria at 7 days, 3 months, and 6 months;It's expected to observe the impact of the clinical performance of restorations in radiation-related caries lesions on patients’ quality of life, assessed using the Oral Health Impact Profile-14 (OHIP-14) at 7 days, 3 months, and 6 months

—

Countries

Contacts

Public ContactPaulo Sérgio Santos

Universidade de São Paulo - Campus Bauru

paulosss@fob.usp.br+55(14)32358000

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Jun 11, 2026