Effect of Prophylaxis Pastes With and Without Desensitizing Agents Prior to In-office Bleaching

August 13, 2026 updated by: Zeinab Omar Tolba, Cairo University

Effect of Prophylaxis Pastes With and Without Desensitizing Agents Prior to In-office Bleaching on Color Change and Tooth Sensitivity: Randomized Clinical Trial

To evaluate the effect of prophylaxis pastes with and without desensitizing agents prior to in-office bleaching on color change and tooth sensitivity.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who have discolored teeth, minimum of 20 natural teeth, good oral hygiene, do not have any systemic disease.

Exclusion Criteria:

  • Patients who have extensive prosthesis or restoration, tetracycline discoloration or fluorosis, endodontically treated teeth or gingival recession, smokers, periodontal disease, pregnant or lactating.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prophylaxis paste with desensitizing agent
Other: Treatment
Prophylaxis paste will be applied to all tooth surfaces using a prophy cup attached to a low-speed contra-angle handpiece. The paste will remain on the teeth for the duration specified in the manufacturer's instructions for use before being rinsed away.
Placebo Comparator: Prophylaxis paste without desensitizing agent
Other: Treatment
Prophylaxis paste will be applied to all tooth surfaces using a prophy cup attached to a low-speed contra-angle handpiece. The paste will remain on the teeth for the duration specified in the manufacturer's instructions for use before being rinsed away.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Color change
Time Frame: Baseline, Immediate after bleaching
Tooth color will be measured using the VITA Easyshade V spectrophotometer. Color measurements will be recorded in the CIE L*, a*, and b* color space, and the color difference will be calculated using the CIEDE2000 color-difference formula (ΔE00).
Baseline, Immediate after bleaching

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tooth sensitivity
Time Frame: Baseline, Immediate after bleaching
Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst pain imaginable). Patients will be asked to place a mark on the 10-cm VAS corresponding to the intensity of their pain.
Baseline, Immediate after bleaching

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Zeinab O Tolba, Associate Professor, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

August 6, 2026

First Submitted That Met QC Criteria

August 13, 2026

First Posted (Actual)

August 18, 2026

Study Record Updates

Last Update Posted (Actual)

August 18, 2026

Last Update Submitted That Met QC Criteria

August 13, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dental desensitizing agent

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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