NCT07247760

Brief Summary

The clinical trial aims to evaluate patient satisfaction and the efficacy of home whitening with 10% carbamide peroxide in masking white spot lesions, as well as the presence of sensitivity and gingival irritation.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Oct 2025Jun 2026

Study Start

First participant enrolled

October 27, 2025

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 25, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

4 months

First QC Date

November 16, 2025

Last Update Submit

November 20, 2025

Conditions

Keywords

white spotbleachingsatisfactiongingival irritationsensitivity

Outcome Measures

Primary Outcomes (1)

  • Degree of satisfaction with whitening on white spot lesions

    The patient will answer questions using the PIDAQ questionnaire to assess whether they consider their white spot lesions to be masked after the whitening treatment.

    2 weeks

Secondary Outcomes (4)

  • Effectiveness of masking white spot lesions

    2 weeks

  • EVALUATION OF DENTAL SENSITIVITY

    2 weeks

  • EVALUATION OF GINGIVAL IRRITATION

    2 weeks

  • EVALUATION OF THE APPEARANCE OF NEW SPOTS

    2 weeks

Study Arms (1)

Whitening treatment for teeth with white spot lesions

EXPERIMENTAL

Whitening treatment with 10% carbamide peroxide on teeth with white spot lesions. Assess patient satisfaction with the masking of white spot lesions and the occurrence of tooth sensitivity and gingival irritation.

Other: Whitening treatment with 10% carbamide peroxide on teeth with white spot lesions

Interventions

Whitening treatment with 10% carbamide peroxide on teeth with white spot lesions. Assess patient satisfaction with the masking of white spot lesions and the occurrence of tooth sensitivity and gingival irritation.

Whitening treatment for teeth with white spot lesions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be over 18 years of age.
  • Have white spots on teeth between 1.3 and 2.3 or between 3.3 and 4.3.
  • No previous dental treatment on teeth affected by hypomineralisation lesions.
  • No active caries lesions at any ICDAS II stage on the anterior teeth.
  • Patients with satisfactory oral hygiene and periodontal health, who are not undergoing periodontal maintenance and who do not use chlorhexidine mouthwashes. Patients with recessions without sensitivity are included.

You may not qualify if:

  • Patients who have previously undergone whitening treatment (less than 5 years ago).
  • Patients undergoing orthodontic treatment.
  • Patients with a history of trauma to the front teeth.
  • Patients with endodontically treated anterior teeth.
  • Pregnant or breastfeeding patients.
  • Patients who smoke.
  • Patients with periodontal disease.
  • Patients with poor oral hygiene.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

Location

MeSH Terms

Conditions

Personal SatisfactionHypersensitivity

Condition Hierarchy (Ancestors)

BehaviorImmune System Diseases

Study Officials

  • Mª VICTORIA FUENTES, PhD Proffesor

    Universidad Rey Juan Carlos

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD DDS

Study Record Dates

First Submitted

November 16, 2025

First Posted

November 25, 2025

Study Start

October 27, 2025

Primary Completion

March 2, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

November 25, 2025

Record last verified: 2025-11

Locations