Efficacy of a Desensitizing Agent During In-Office Bleaching

University of Santiago de Compostela

Status and phase: Completed; Early Phase 1

Conditions: Sensitivity, Tooth

Treatments: Drug: Placebo; Drug: UltraEZ

Study type: Interventional

Funder types: Other

Identifiers

NCT07355647

2025/01

Details and patient eligibility

About

The main objective of this study is to evaluate if the use of a desensitizing agent (UltraEZ) during in-office 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 patient's medical history, general examination, and prophylaxis. Alginate impressions will be taken of the upper and lower arches for all the patients who meet the inclusion criteria. The impressions will be poured into plaster, and individualized trays will be made for each patient. A positioning guide-finder tray will be fabricated for each patient for color measurement.
2. Visit 2: Initial color measurement with a spectrophotometer and the positioning guide. Each patient will receive their individualized tray. A blinded clinical will put inside the trays the desensitizing agent (UltraEZ, Ultradent Products Inc.,South Jordan, UT,USA) or placebo. The patients had to wear it for 30 minutes. Then after a correct isolation the clinicians apply over the buccal surface from premolar to premolar of both arches the bleaching agent (Opalescence Boost 40%, Ultradent Products, South Jordan, USA).Two application of 20 minutes each. The sensitivity was recorded and patient were given a sensitivity test to record at home.
3. Visit 3: One week after the first bleaching session. Color measurement with a spectrophotometer and the positioning guide. In this visit the second bleaching session was done with the same steps as visit 2.
4. Visit 4: 15 days after the second bleaching session. Final data collection (color + patients sensitivity test)

Enrollment: 30 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• No oral os systemic pathology
• Periodontally Healthy
• No cavities
• Tooth shade of the canines A2 or darker

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

UltraEZ Group

Experimental group

Description:

A blinded clinician put in the patient bleaching trays the UltraEZ desensitizing gel, patients had to wear it 30 minutes before the session of in-office bleaching

Treatment:

Drug: UltraEZ

Placebo Group

Placebo Comparator group

Description:

A blinded clinician put in the patient bleaching trays the placebo desensitizing gel, patients had to wear it 30 minutes before the session of in-office bleaching

Treatment:

Drug: Placebo