White Spot LesionsNCT07247760
PATIENT SATISFACTION AND MASKING OF WHITE SPOT LESIONS AFTER HOME WHITENING WITH 10% CARBAMIDE PEROXIDE
A study testing Whitening treatment with 10% carbamide peroxide on teeth with white spot lesions in people with White Spot Lesions, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- White Spot Lesions
- What is being tested?
- Whitening treatment with 10% carbamide peroxide on teeth with white spot lesions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteSpain
- Study dates
- 27 Oct 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: PATIENT SATISFACTION AND MASKING OF WHITE SPOT LESIONS AFTER HOME WHITENING WITH 10% CARBAMIDE PEROXIDE: CLINICAL TRIAL
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.
Read the detailed description
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. Patients with at least one white spot due to enamel development defects in any of the anterior teeth will be selected, up to a minimum of 67 lesions. An initial characterisation of the white spot lesions will be performed using different standardised photographs with cross-polarisation filters, fluorescence and transillumination. In addition, mapping will be performed using a spectrophotometer to record the L*a*b* parameters in the lesions and surrounding tissue, and patients will initially respond to a survey on their satisfaction with the lesions (VAS scale) and their impact on psychosocial well-being and oral health-related quality of life (PIDAQ and OHIP-14, respectively). Patients classified for the study will be whitened with 10% carbamide peroxide for 3 hours a day for 4 weeks, or until the desaturation obtained is to their liking, or until the CIELAB L* parameter measurements indicate stabilisation of brightness using the spectrophotometer. During treatment, the presence of sensitivity and irritation will be recorded using a VAS scale. Patients will be reviewed 4 weeks after the end of treatment and will respond again to the questionnaire on satisfaction, psychosocial impact of dental aesthetics and oral quality of life (PIDAQ and OHIP-14), and the lesions will be characterised again. The data obtained on satisfaction, PIDAQ and OHIP-14 surveys will be statistically analysed, as will the colour difference between the lesions and the surrounding tissue enamel at the end of treatment.
- Conditions
- White Spot Lesions
- Being tested
- Whitening treatment with 10% carbamide peroxide on teeth with white spot lesions
- Keywords
- white spot, bleaching, satisfaction, gingival irritation, sensitivity
- Medical subject headings
- Personal Satisfaction, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whitening treatment with 10% carbamide peroxide on teeth with white spot lesionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Whitening treatment with 10% carbamide peroxide on teeth with white spot lesions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (4)
Effectiveness of masking white spot lesions
The lesions will be characterised as described above at 4 weeks and one month after the end of the whitening treatment. If the whitening treatment is prolonged, this will also be done at the end of the treatment. The effectiveness of masking will be determined by the colour difference between the lesions and the surrounding tissue using the CIELAB formula (De L'Eclairage, 1978):
∆Eab = [(∆L*)2 + (∆a*)2 + (∆b*)2]1/2. By definition, a tooth is considered masked when the colour difference (ΔEab) between the lesions and the surrounding healthy enamel is ΔEab ≤3.7, and unmasked if ΔEab > 3.7. A colour difference below the acceptability threshold of 3.7 was chosen as an indicator of masking.
In addition, the colour change will also be calculated using the CIEDE 2000 formula:
Additionally, the CIEDE2000 formula will be applied;
∆E00 = [(ΔL/kLSL)2 + (ΔC/kCSC)2 + (ΔH/kHSH)2 + RT(ΔC*ΔH/SC*SH)]1/2
and the whiteness index (WI)
Measured: 2 weeks
EVALUATION OF DENTAL SENSITIVITY
We will assess sensitivity and intensity using a visual analogue scale (VAS) from 0 to 10. Each patient will be given a diary covering the two weeks between appointments, which they will have to fill in daily. Zero will represent 'no pain' on the visual analogue scale and ten will represent 'severe pain'. Patients will be asked to record the worst result once a day, even if there has been no pain, marking with a vertical line the value corresponding to the intensity of their tooth sensitivity, which will then be measured in centimetres. If the patient marks any value above zero, it will be interpreted as tooth sensitivity. In cases of severe sensitivity, desensitising agents or analgesics/anti-inflammatories will be dispensed.
Measured: 2 weeks
EVALUATION OF GINGIVAL IRRITATION
We will assess gingival irritation and the intensity of said irritation using a visual analogue scale (VAS) from 0 to 10 by means of a diary that will be provided together with the dental sensitivity diary, which the patient will fill in the same way, with zero being 'no gingival irritation' and ten being 'severe irritation'. Patients will be asked to record the worst result once a day, even if there has been no irritation, marking with a vertical line the value corresponding to the intensity of gingival irritation, which will then be measured in cm.
Measured: 2 weeks
EVALUATION OF THE APPEARANCE OF NEW SPOTS
We will assess the appearance of new lesions during treatment using a visual analogue scale (VAS) from 0 to 10 in a diary that will be provided along with the tooth sensitivity diary, which the patient will fill out in the same way, with zero being 'very dissatisfied' and ten being 'very satisfied'. Patients will be asked to record the worst result once a day by marking with a vertical line the value corresponding to the intensity of gingival irritation, which will then be measured in centimetres.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start27 Oct 2025
- Primary completion2 Mar 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for White Spot LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabel Giráldez de Luis, Universidad Rey Juan Carlos
- Investigators
- Mª VICTORIA FUENTES, PhD Proffesor, Study director, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247760
- Sponsor's protocol ID
- URJC_IDIBO_5
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PATIENT SATISFACTION AND MASKING OF WHITE SPOT LESIONS AFTER HOME WHITENING WITH 10% CARBAMIDE PEROXIDE: CLINICAL TRIAL
- ClinicalTrials.gov ID
- NCT07247760
- Acronym / sponsor ID
- URJC_IDIBO_5
- Conditions
- White Spot Lesions
- Keywords
- white spot, bleaching, satisfaction, gingival irritation, sensitivity
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 2 Mar 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Patients with at least one white spot due to enamel development defects in any of the anterior teeth will be selected, up to a minimum of 67 lesions. An initial characterisation of the white spot lesions will be performed using different standardised photographs with cross-polarisation filters, fluorescence and transillumination. In addition, mapping will be performed using a spectrophotometer to record the L*a*b* parameters in the lesions and surrounding tissue, and patients will initially respond to a survey on their satisfaction with the lesions (VAS scale) and their impact on psychosocial well-being and oral health-related quality of life (PIDAQ and OHIP-14, respectively). Patients classified for the study will be whitened with 10% carbamide peroxide for 3 hours a day for 4 weeks, or until the desaturation obtained is to their liking, or until the CIELAB L* parameter measurements indicate stabilisation of brightness using the spectrophotometer. During treatment, the presence of sensitivity and irritation will be recorded using a VAS scale. Patients will be reviewed 4 weeks after the end of treatment and will respond again to the questionnaire on satisfaction, psychosocial impact of dental aesthetics and oral quality of life (PIDAQ and OHIP-14), and the lesions will be characterised again. The data obtained on satisfaction, PIDAQ and OHIP-14 surveys will be statistically analysed, as will the colour difference between the lesions and the surrounding tissue enamel at the end of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Whitening treatment for teeth with white spot lesions | Experimental | Other: Whitening treatment with 10% carbamide peroxide on teeth with white spot lesionsWhitening 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whitening treatment with 10% carbamide peroxide on teeth with white spot lesionsWhitening 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 for teeth with white spot lesions |
Primary outcome
Degree of satisfaction with whitening on white spot lesions
Time frame: 2 weeks
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.
4 secondary outcomes
Effectiveness of masking white spot lesions
Time frame: 2 weeks
EVALUATION OF DENTAL SENSITIVITY
Time frame: 2 weeks
EVALUATION OF GINGIVAL IRRITATION
Time frame: 2 weeks
EVALUATION OF THE APPEARANCE OF NEW SPOTS
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mª VICTORIA FUENTES, PhD Proffesor study director
Universidad Rey Juan Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whitening treatment with 10% carbamide peroxide on teeth with white spot lesions in people with White Spot Lesions, run by Universidad Rey Juan Carlos at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of satisfaction with whitening on white spot lesions (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.