Skip to content

Teeth bleaching and its effects on sensitivity and people's well-being

Dental Bleaching: tooth sensitivity, psychosocial impact and impact on oral health-related quality of life using different desensitization protocols: randomized clinical trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-65cdkc5
Enrollment
Unknown
Registered
2025-10-06
Start date
2025-07-03
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

This study is a randomized, controlled, double-blind clinical trial with four arms, involving 72 eligible participants who will be randomly assigned to four groups (n = 18 per group). All participants
G2 (In-office Whitening with 35% HP + KNO3)
G3 (In-office Whitening with 35% HP + Gluma Desensitizer)
G4 (In-office Whitening with 35% HP + KNO3 + Gluma Desensitizer). Participant allocation will be carried out randomly using randomization software to ensure equitable distribution, and both the partic

Sponsors

Universidade Federal do Maranhão
Lead Sponsor
Universidade Federal do Maranhão
Collaborator

Eligibility

Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Male or female patients; aged 18 to 40 years; patients without systemic diseases (metabolic, immunological, and heart diseases); oral condition without periodontal diseases; at least two canines with shade C2 or darker, assessed using the VITA classical A1-D4® scale; six maxillary anterior teeth free of restorations on the palatal and buccal surfaces; sound enamel with no pathological, physiological, or drug-induced alterations

Exclusion criteria

Exclusion criteria: Volunteers with orthodontic appliances; severe crowding; presence of intrinsic stains (tetracycline staining, fluorosis, non-vital teeth); use of anti-inflammatory drugs; smokers; alcohol consumers; pregnant or breastfeeding women; participants who have already undergone a bleaching procedure; participants with bruxism or significant oral pathologies; participants with dentin exposed on the incisal portion of anterior teeth; non-carious cervical lesions

Design outcomes

Primary

MeasureTime frame
t is expected to observe differences in the intensity of tooth sensitivity among the groups submitted to in-office bleaching with different desensitizing protocols. The intensity will be assessed using the Visual Analog Scale (VAS, 0–100 mm), applied before, immediately after, 1 hour, 24 hours, and 7 days following each bleaching session. The worst scores reported by each patient will be considered, classified as none (0–4 mm), mild (5–44 mm), moderate (45–74 mm), and severe (75–100 mm). Comparisons will be performed using two-way ANOVA and Tukey’s test. It is expected to observe differences in tooth color change among the desensitizing protocols. The color change will be assessed subjectively (Vita Classical A1–D4® and Vita Bleachedguide® scales) and objectively (Easyshade® spectrophotometer, L*, a*, b* values). The parameters analyzed will include ?E, ?E00, and ?WID, calculated at T1 (baseline), T2 (7 days), and T3 (1 month).

Secondary

MeasureTime frame
It is expected to observe differences in the impact on oral health-related quality of life among the groups, assessed using the OHIP-Aes questionnaire (14 items, Likert scale 0–4). The evaluation will be performed at T1 (baseline), T2 (1 week after the third bleaching session), and T3 (3 months after treatment), considering the variation in total scores and by domains.

Countries

Brazil

Contacts

Public ContactJardel Silva

Universidade Federal do Maranhão

jardel.santos17@hotmail.com+ 55 (098) 81044712

Outcome results

None listed

Source: REBEC (via WHO ICTRP)