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The effect of Dental Bleaching on tooth sensitivity and quality of life

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-27m45tt
Enrollment
Unknown
Registered
2024-10-14
Start date
2024-03-24
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 five arms, involving 100 eligible participants who will be randomly allocated into five groups (n = 20 per group). All particip
Group 2 (G2) will receive whitening with 35% hydrogen peroxide and Gluma Desensitizer application
Group 3 (G3) will have whitening with 35% hydrogen peroxide and low-level laser application
Group 4 (G4) will be treated with 35% hydrogen peroxide, potassium nitrate, and low-level laser
and Group 5 (G5) will receive whitening with 35% hydrogen peroxide, Gluma Desensitizer, and low-level laser. Participant allocation will be conducted randomly using a randomization software to ensure
E06.420.750

Sponsors

Universidade Federal do Maranhão
Lead Sponsor
Universidade Federal do Maranhão
Collaborator

Eligibility

Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 40 years; patients without systemic diseases (metabolic, immunological, and heart diseases); oral condition without periodontal diseases; at least two canines with color C2 or darker, evaluated by the VITA classical A1-D4® shade guide; six upper anterior teeth free of restorations on the palatal and buccal surfaces; healthy enamel without pathological, physiological, and medication-induced alterations.

Exclusion criteria

Exclusion criteria: volunteers with orthodontic appliances; severe crowding; presence of intrinsic stains (tetracycline staining, fluorosis, non-vital teeth); using anti-inflammatory drugs; smokers; alcohol users; pregnant or breastfeeding women; participants who have already undergone whitening procedures; participants with bruxism or significant oral pathologies; participants with exposed dentin in the incisal portion of the anterior teeth; and with non-carious cervical lesions

Design outcomes

Primary

MeasureTime frame
Expected Outcome: To evaluate dental sensitivity and whitening effectiveness using different desensitizing methods. The method used to verify the expected outcome will be assessed through sensitivity measurements and colorimetric analysis before and after the intervention. Parameters such as numerical scores for sensitivity and shade changes (?E) will be used to determine if the outcomes were achieved.

Secondary

MeasureTime frame
Expected Outcome: To evaluate the quality of life and psychosocial impact of dental aesthetics before and after the intervention. The method used to verify the expected outcome will involve the application of validated questionnaires measuring the participants' perception of their dental aesthetics and its impact on their quality of life. Parameters such as scores from the OHIP (Oral Health Impact Profile) and the PIDAQ (Psychosocial Impact of Dental Aesthetics Questionnaire) will be analyzed to assess changes pre- and post-intervention.

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)