Efficacy of a Desensitizing Agent During At-home Bleaching

University of Santiago de Compostela

Status and phase: Completed; Early Phase 1

Conditions: Sensitivity, Tooth

Treatments: Drug: UltraEZ; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06371092

2023/01

Details and patient eligibility

About

The main objective of this study is to evaluate if the use of UltraEZ during at-home bleaching treatment is effective in reducing tooth sensitivity, as well as doesn't affect the degree of tooth bleaching.

Full description

1. Visit 1: Study information and delivery of informed consent. Recording of the patient's medical history, general examination, and prophylaxis. Alginate impressions will be taken of the upper and lower arches for all patients who meet the inclusion criteria. The impressions will be poured into plaster, and individualized bleaching trays will be made for each patient. A positioning guide tray will be fabricated for color measurement.
2. Visit 2: Initial color measurement with a spectrophotometer and the positioning guide. Each patient will receive their individualized trays. Additionally, they will be given 3 syringes of bleaching agent (Opalescence 16%, Ultradent Products) and one syringe of desensitizing agent (UltraEZ, Ultradent Products) or placebo (glycerin), according to their study group. Both the desensitizing agent and placebo will be dispensed in identical syringes, coded as A and B, to ensure the blinding of the study; only the clinician responsible for randomization knows the coding. Each patient will be provided with an instruction sheet and recording sheets to fill out daily during the 3-week study period. They will record the degree of dental sensitivity .
3. Visit 3: First-week bleaching review. Data collection (color + sensitivity).
4. Visit 4: Second-week bleaching review. Data collection (color + sensitivity).
5. Visit 5: Third-week bleaching review and end of the study. Data collection (color + sensitivity).

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• No oral or systemic pathology
• Periodontally healthy
• No cavities
• Tooth shade of the upper and lower canines A2 or darker

Exclusion criteria

• Adhesive restorations or prostheses in the anterior region
• Enamel or dentin alterations
• Smoking
• Pregnant women
• Undergone prior bleaching treatment

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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32 participants in 2 patient groups, including a placebo group

UltraEZ Group

Experimental group

Description:

Patients put in their bleaching trays the UltraEZ desensitizing gel for 30 minutes before the bleaching treatment every day during three weeks.

Treatment:

Drug: UltraEZ

Placebo Group

Placebo Comparator group

Description:

Patients put in their bleaching trays the UltraEZ placebo gel for 30 minutes before the bleaching treatment every day during three weeks.

Treatment:

Drug: Placebo