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Saturation point for at-home bleaching

Clinical assessment of the saturation point in teeth whitening

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-5kwy8yf
Enrollment
Unknown
Registered
2025-07-29
Start date
2025-05-15
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

Dentinal Sensitivity

Interventions

This is a single-arm clinical study, blinded to the intervention evaluators. Forty participants will be recruited and alginate impressions of the upper and lower jaws of each participant will be taken
E06.420.750

Sponsors

Universidade Tuiuti do Paraná
Lead Sponsor
Universidade Tuiuti do Paraná
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Minimum age of 18 years; of both sexes; good general and oral health, without systemic diseases that may interfere with dental whitening; absence of periodontal disease, gingival recession or carious lesions in anterior teeth; upper canines with Whiteness Index for Dentistry (WID) shade less than 20 equivalent to A2 or darker, according to the Vita Classical scale (Vita Zahnfabrik, Bad Säckingen, Germany); absence of restorations in anterior teeth, ensuring an accurate analysis of the color change; availability to attend consultations and follow the experimental protocol

Exclusion criteria

Exclusion criteria: Previous history of dental whitening; pre-existing dentin hypersensitivity, reported by the participant or identified during screening; continuous use of analgesic or anti-inflammatory medications, which may interfere with the perception of dental sensitivity; use of orthodontic appliances, dentures or restorations in anterior teeth, as they may influence the assessment of color; previous endodontic treatment in anterior teeth, which may affect the response to whitening; presence of severe tooth discoloration, including severe fluorosis, pulpless teeth or stains resulting from the use of tetracycline; visible cracks in tooth enamel, which may compromise the response to whitening; pregnancy or lactation, due to the lack of studies on the safety of whitening in this population; smoking or bruxism, which may influence color stability and oral health

Design outcomes

Primary

MeasureTime frame
Monitor the evolution of color change over time in patients undergoing home whitening with 10% carbamide peroxide, identifying the saturation point, that is, the moment at which the color variation becomes clinically insignificant.

Secondary

MeasureTime frame
To evaluate the evolution of tooth color throughout home whitening treatment using 10% carbamide peroxide, using spectrophotometry (Vita Easyshade) and visual scales (Vita Classical and Vita Bleachedguide 3D-MASTER).;Assess dental sensitivity throughout treatment, analyzing the frequency, intensity and duration of symptoms reported by participants.;Analyze the occurrence of gum irritation associated with prolonged use of the whitening gel, identifying its frequency, intensity and duration.;Examine participants' perception of the treatment, using a questionnaire that assesses aesthetic satisfaction, impact on quality of life and comfort during the whitening process.

Countries

Brazil

Contacts

Public ContactMichael Favoreto

Universidade Tuiuti do Paraná

michaelfavoreto@hotmail.com+55(41) 3331-7700

Outcome results

None listed

Source: REBEC (via WHO ICTRP)