NCT07770373

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 18, 2026

Completed
Last Updated

August 18, 2026

Status Verified

August 1, 2026

Enrollment Period

Same day

First QC Date

August 6, 2026

Last Update Submit

August 13, 2026

Conditions

Keywords

bleachingdesensitizing agentsdiscoloration

Outcome Measures

Primary Outcomes (1)

  • Color change

    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 Outcomes (1)

  • Tooth sensitivity

    Baseline, Immediate after bleaching

Study Arms (2)

Prophylaxis paste with desensitizing agent

EXPERIMENTAL

Prophylaxis paste with desensitizing agent

Other: Treatment

Prophylaxis paste without desensitizing agent

PLACEBO COMPARATOR

Prophylaxis paste without desensitizing agent

Other: Treatment

Interventions

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.

Prophylaxis paste with desensitizing agentProphylaxis paste without desensitizing agent

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tooth Discoloration

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Zeinab O Tolba, Associate Professor

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeinab O Tolba, Associate Professor

CONTACT

Possy M Abd El Aziz, Associate Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Conservative Dentistry Department, Faculty of Dentistry, Cairo University

Study Record Dates

First Submitted

August 6, 2026

First Posted

August 18, 2026

Study Start

August 1, 2026

Primary Completion

August 1, 2026

Study Completion

August 1, 2026

Last Updated

August 18, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share