Skip to content

Efficacy of in-office bleaching using coupled bleaching gel after one week of manipulation

Efficacy of in-office bleaching using coupled bleaching gel after one week of manipulation: a randomized triple-blind and equivalence clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6jpgyjr
Enrollment
Unknown
Registered
2023-06-13
Start date
2023-05-12
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

Dentin Sensitivity

Interventions

It will be a triple-blind split-mouth study where the evaluator, the patient and the operator will not know the assignment of the groups. 40 patients will be allocated through a simple randomization,
E06.420.750

Sponsors

Universidade Estadual de Ponta Grossa
Lead Sponsor
Universidade Estadual de Ponta Grossa
Collaborator

Eligibility

Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 60 years; both genders; good general and oral health; healthy vital teeth; minimum color A2; agree and sign the informed consent form (TCLE)

Exclusion criteria

Exclusion criteria: Whitening procedure previously; previous dental sensitivity; dental prosthesis; fixed orthodontic appliance; restorations in the anterior superior teeth; endodontic treatment on anterosuperior teeth; gingival recessions; teeth stained by tetracycline or fluorosis; visible cracks in the teeth; continuous use of medications; pregnant or lactating women; bruxism; smokers

Design outcomes

Primary

MeasureTime frame
Evaluate the effectiveness of the color change. Data collected before, weekly for 2 weeks and 30 days after the end of treatment, using the subjective scales method, and digital spectrophotometer.

Secondary

MeasureTime frame
Assess the absolute risk of tooth sensitivity. Patients will be expected to report spontaneous pain at some point or up to 48 hours after each session, using the VAS visual analogue scale (0 to 10). The percentage of patients with pain will be called the absolute risk of tooth sensitivity.;Evaluate the intensity of dental sensitivity through the records made by the patients using the visual analogue VAS scale (0 to 10). Values ??will be presented as mean and standard deviation.;Assess the absolute risk of gingival irritation. Patients will be expected to report irritation at some point or up to 48 hours after each session using the VAS visual analogue scale (0 to 10). The percentage of patients with pain will be called the absolute risk of gingival irritation.;Evaluate the intensity of gingival irritation through the records made by patients using the VAS visual analogue scale (0 to 10). Values ??will be presented as mean and standard deviation.;Evaluate Aesthetic Self-Perception using the Orofacial Aesthetic Scale (OEE) before, weekly for 2 weeks and one month after the end of the procedure.

Countries

Brazil

Contacts

Public ContactComitê em Pesquisa

Universidade Estadual de Ponta Grossa

propespsecretaria@uepg.br+55(42)3220-3282

Outcome results

None listed

Source: REBEC (via WHO ICTRP)