Efficacy of a Desensitizing Agent During At-home Bleaching

NCT06371092 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 2023/01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Sensitivity, Tooth

Keywords

Tooth bleaching; Vital bleaching; Desensitizing agents; Tooth sensitivity

Outcome Measures

Primary Outcomes (1)

• Questionnaire of dental sensitivity

  Patients should answer a dental sensitivity questionnaire. A a 5-point subjective numerical classification scale will be used (0=no sensitivity, 1=light, 2=mild, 3=considerable and 4=severe). Patients will a score of 0 during the treatment will be defined as patients with no sensitivity. The individual highest recorded score will be the grade of intensity for each patient.

  Daily, during 3 weeks

Secondary Outcomes (1)

• Shade evaluation with a dental spectrophotometer

  Once a week, during 3 weeks

Study Arms (2)

UltraEZ Group

EXPERIMENTAL

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

Drug: UltraEZ

Placebo Group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

UltraEZ 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

UltraEZ Group

Placebo 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

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Santiago de Compostela: lead

Study Sites (1)

School of Medicine and Dentistry

Santiago de Compostela, A Coruña, 15705, Spain

Location

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

UltraEZ

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, triple-blind clinical trial

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 17, 2024
• Study Start: January 31, 2023
• Primary Completion: February 22, 2023
• Study Completion: March 1, 2023
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)