Efficacy of a Desensitizing Agent During In-Office Bleaching

NCT07355647 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 2025/01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sensitivity, Tooth

Keywords

Tooth Bleaching; In-Office Bleaching; Desensitizing Agents; Tooth Sensitivity

Outcome Measures

Primary Outcomes (1)

• Questionary of dental sensitivity

  General tooth sensitivity was assessed using a 5-point Numeric Rating Scale (NRS), where 0 = no sensitivity; 1 = mild discomfort; 2 = moderate discomfort that does not interfere with daily activities; 3 = considerable discomfort leading to avoidance of certain foods and beverages; and 4 = severe sensitivity requiring interruption of the bleaching treatment. Participants selected the numeric value that best represented their perceived level of tooth sensitivity. Pain intensity was recorded at the following time points: * Perioperative * 1 hour postoperatively * 24 hours postoperatively * 48 hours postoperatively

  Perioperative, 1 hour postoperative, 24 hours postoperative, 48 hours postoperative

Secondary Outcomes (1)

• Color evaluation of each patient

  Baseline (Bleaching Day 1), 1 week later baseline (Before Bleaching day 2), Revision (One week after second bleaching session)

Study Arms (2)

UltraEZ Group

EXPERIMENTAL

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

Drug: UltraEZ

Placebo Group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

UltraEZ DRUG

General Examination with bite-wings, dental prophylaxis, alginate impressions of both arches, creation of individualized bleaching trays and position finder trays. Application of the UltraEZ in the bleaching trays for 30 minutes. Isolation of the gingival tissues. Two applications of the bleaching agent of 20 minutes

UltraEZ Group

Placebo DRUG

General Examination with bite-wings, dental prophylaxis, alginate impressions of both arches, creation of individualized bleaching trays and position finder trays. Application of the placebo in the bleaching trays for 30 minutes. Isolation of the gingival tissues. Two applications of the bleaching agent of 20 minutes

Placebo Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Adhesive restorations or protheses in the anterior region
• Enamel or dentin alterations
• Smoking habits
• 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: December 10, 2025
• First Posted: January 21, 2026
• Study Start: May 15, 2025
• Primary Completion: July 16, 2025
• Study Completion: July 16, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)