Clinical study of nuclear alterations in patients undergoing in-office tooth whitening

Evaluation of the genotoxic potential of dental whitening in patients with different age groups: clinical study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-4ttb63q

Enrollment

Unknown

Registered

2024-05-24

Start date

2022-11-01

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

Genotoxicity

Interventions

This is a controlled, blind clinical trial, in which the evaluator was unaware of the group assignment. The study was structured based on Consolidated Standards of Reporting Trials (CONSORT). The volu

E06.420.750

Eligibility

Age

14 Years to 50 Years

Inclusion criteria

Inclusion criteria: Both sexes; age between 14 and 18 years old and 31 and 50 years old; no systemic diseases (metabolic, immunological and heart diseases); with oral condition free from carious lesions or periodontal diseases; central incisor or canine color A2 or darker; six upper anterior teeth free of restorations on the buccal surface; healthy enamel; dissatisfaction with the color of your teeth; no pathological changes; physiological and medicinal

Exclusion criteria

Exclusion criteria: Dentin hypersensitivity; smoker; alcoholic; pregnant or breastfeeding; orthodontic appliance; severe crowding, presence of intrinsic spots and ages between 19 and 30 years old

Design outcomes

Primary

Measure	Time frame
To evaluate the genotoxicity of tooth whitening between age groups using the micronucleus test. For the whitening procedure to be considered safe, it is expected not to find an average difference greater than 1	—

Secondary

Measure	Time frame
Evaluate the difference in the frequency of micronuclei between different age groups; evaluate the frequency of other nuclear alterations (karyolysis, karyorrhex, pycnosis, condensed chromatin, binucleated cells and nuclear button) in the gingiva of young and adult patients undergoing in-office tooth whitening	—

Countries

Brazil

Contacts

Public ContactAnna Coêlho

Faculdade de Odontologia - Universidade Federal do Amazonas

annapaulacoelho11@gmail.com+55(92)992768494

Outcome results

None listed

Source: REBEC (via WHO ICTRP)