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Assessment of bleaching efficacy using two concentrations of carbamide peroxide in home bleaching in adolescents

Assessment of bleaching efficacy using two concentrations of carbamide peroxide in home bleaching in adolescents: double-blind randomized clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-44k3f3x
Enrollment
Unknown
Registered
2024-08-23
Start date
2024-09-02
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

Tooth Bleaching, Adolescent, Dentin Sensitivity

Interventions

This is an equivalence, prospective, randomized, controlled, parallel, and double-blind study. All participants will be informed about the nature and objectives of the study. The study will be conduct

Sponsors

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

Eligibility

Age
12 Years to 16 Years

Inclusion criteria

Inclusion criteria: Good general and oral health; 12 to 16 years old; Six upper anterior teeth free of active caries and endodontic treatment; restorations of a maximum of 1/3 of the dental structure; canines (13,23) should be A2 color or darker.

Exclusion criteria

Exclusion criteria: Participants undergoing orthodontic treatment; dental prostheses; severe tooth discoloration (tetracycline stains, fluorosis or devitalized teeth); pregnant and lactating patients, continuous users of anti-inflammatories or analgesics; participants who have already undergone teeth whitening procedures.

Design outcomes

Primary

MeasureTime frame
Experienced, blinded, and calibrated evaluators, who did not participate in patient guidance (kappa greater than 80 percent), will perform clinical color assessments at baseline, weekly during treatment (at 7, 14, and 21 days), and one month after the end of the whitening treatment. Color assessment will be conducted using the VITA Easyshade spectrophotometer (VITA Zahnfabrik, Bad Säckingen, Germany) and the VITA Classical and VITA Bleachedguide 3DMASTER shade guides. The 16 tabs of the VITA Classical shade guide will be arranged from the highest value (B1) to the lowest value (C4). The VITA Bleachedguide 3DMASTER contains tabs of lighter shades and is already organized from the highest value (0M1) to the lowest value (5M3). The tooth area used for color assessment will be the middle third of the vestibular surface of the upper canines (13, 23). For standardizing color measurement with the spectrophotometer, a silicone guide with a 6 mm aperture in the middle third of the canines' crowns will be made to fit the tip of the spectrophotometer. The color parameters L (value from 0 [black] to 100 [white]), a (red-green axis), and b (yellow-blue axis) will be measured with the spectrophotometer. The color change between baseline and each time point will be used to calculate delta Eab 18 and delta E00. We will also calculate the whitening index (WID), where higher values indicate a greater degree of whitening.

Secondary

MeasureTime frame
Evaluate patient satisfaction after teeth whitening. Before and after whitening, patients will complete the Orofacial Aesthetics Scale (EEO), which is a numerical scale from 0 to 10 (0 - "very dissatisfied" and 10 - "very satisfied"), with the option "not applicable" if the patient prefers not to answer a particular question. The EEO items refer to seven aesthetic components (face, facial profile, mouth, tooth alignment, tooth shape/form, tooth color, gums), and these seven items are combined into a summary score ranging from 0 to 70 (maximum score when the patient is completely satisfied). An eighth item of the EEO assesses the overall orofacial aesthetics of the patient.;Assess the dental sensitivity reported by patients after teeth whitening in adolescents. Patients will be instructed to record their experience of dental sensitivity (SD) daily through WhatsApp messages. Each day, one of the blinded study evaluators will send a message asking about the level of SD for that day. Participants will be instructed to record the highest intensity of SD by providing a value between 0 and 10, where 0 means no SD and 10 means severe SD. The highest and the average value of all daily assessments will be used for data analysis of SD intensity. A participant who scores 0 on all assessments will be considered insensitive to SD/IG. If the participant scores at least one day on the visual analog scale (VAS), they will be considered sensitive to SD, indicating some risk related to these factors.

Countries

Brazil

Contacts

Public ContactAna Chibinski

Universidade Estadual de Ponta Grossa

propespsecretaria@uepg.br+55 (042)3220-3740

Outcome results

None listed

Source: REBEC (via WHO ICTRP)