Efficacy of a Desensitizing Agent During At-home Bleaching

NCT ID: NCT06371092

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2023-03-01

Brief Summary

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.

Detailed 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).

Conditions

Sensitivity, Tooth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

UltraEZ Group

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

Group Type: EXPERIMENTAL

UltraEZ

Intervention Type: DRUG

General examination with bite-wings. Dental prophylaxis (dental scaling and polishing with an abrasive paste). Alginate impressions of both arches. Creation of individualized bleaching trays and a position-finder tray of both arches. Application of the UltraEZ gel in the bleaching trays for 30 minutes. Application of the bleaching gel in the bleaching trays during 6-8 hours

Placebo Group

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

General examination with bite-wings. Dental prophylaxis (dental scaling and polishing with an abrasive paste). Alginate impressions of both arches. Creation of individualized bleaching trays and a position-finder tray of both arches. Application of the placebo gel in the bleaching trays for 30 minutes. Application of the bleaching gel in the bleaching trays during 6-8 hours

Interventions

UltraEZ

General examination with bite-wings. Dental prophylaxis (dental scaling and polishing with an abrasive paste). Alginate impressions of both arches. Creation of individualized bleaching trays and a position-finder tray of both arches. Application of the UltraEZ gel in the bleaching trays for 30 minutes. Application of the bleaching gel in the bleaching trays during 6-8 hours

Intervention Type: DRUG

Placebo

General examination with bite-wings. Dental prophylaxis (dental scaling and polishing with an abrasive paste). Alginate impressions of both arches. Creation of individualized bleaching trays and a position-finder tray of both arches. Application of the placebo gel in the bleaching trays for 30 minutes. Application of the bleaching gel in the bleaching trays during 6-8 hours

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Santiago de Compostela

OTHER

Sponsor Role: lead

Responsible Party

Patricia Pereira-Lores

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

School of Medicine and Dentistry

Santiago de Compostela, A Coruña, Spain

Countries

Spain

Other Identifiers

2023/01

Identifier Type: -

Identifier Source: org_study_id