Sensitivity, ToothEarly Phase 1NCT07355647
Efficacy of a Desensitizing Agent During In-Office Bleaching
A Early Phase 1 study testing UltraEZ in people with Sensitivity, Tooth, run by University of Santiago de Compostela at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Sensitivity, Tooth
- What is being tested?
- UltraEZ
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 15 May 2025to 16 Jul 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No oral os systemic pathology
- Periodontally Healthy
- No cavities
- Tooth shade of the canines A2 or darker
Who cannot join
- Adhesive restorations or protheses in the anterior region
- Enamel or dentin alterations
- Smoking habits
- Pregnant women
- Undergone prior bleaching treatment
Trial locations and contacts
1 site in 1 country.
Spain1 site
School of Medicine and Dentistry
Santiago de Compostela, A Coruña, 15705
About this study
Official title: A Triple Blind Randomized Clinical Trial Comparing the Efficacy of a Desensitizing Agent Used With an In-Office Bleaching Technique
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.
Read the detailed description
- Visit 1: Study information and delivery of informed consent. Recording of patient's medical history, general examination, and prophylaxis. Alginate impressions will be taken of the upper and lower arches for all the patients who meet the inclusion criteria. The impressions will be poured into plaster, and individualized trays will be made for each patient. A positioning guide-finder tray will be fabricated for each patient for color measurement.
- Visit 2: Initial color measurement with a spectrophotometer and the positioning guide. Each patient will receive their individualized tray. A blinded clinical will put inside the trays the desensitizing agent (UltraEZ, Ultradent Products Inc.,South Jordan, UT,USA) or placebo. The patients had to wear it for 30 minutes. Then after a correct isolation the clinicians apply over the buccal surface from premolar to premolar of both arches the bleaching agent (Opalescence Boost 40%, Ultradent Products, South Jordan, USA).Two application of 20 minutes each. The sensitivity was recorded and patient were given a sensitivity test to record at home.
- Visit 3: One week after the first bleaching session. Color measurement with a spectrophotometer and the positioning guide. In this visit the second bleaching session was done with the same steps as visit 2.
- Visit 4: 15 days after the second bleaching session. Final data collection (color + patients sensitivity test)
- Conditions
- Sensitivity, Tooth
- Being tested
- UltraEZ, Placebo
- Keywords
- Tooth Bleaching, In-Office Bleaching, Desensitizing Agents, Tooth Sensitivity
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltraEZDrug
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
PlaceboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Perioperative, 1 hour postoperative, 24 hours postoperative, 48 hours postoperative
Secondary outcomes (1)
Color evaluation of each patient
Tooth color will be measured using a dental spectrophotometer, recording the following parameters: L (lightness, representing the shade from black to white on a scale of 0 to 100), a (color variation along the red-green axis, with positive values toward red/purple and negative values toward green/blue), b (color variation along the yellow-blue axis, with positive values toward yellow and negative values toward blue/purple), C (chroma, describing the intensity or saturation of a color, expressed on a scale from 0 to 40, where 0 indicates no saturation and 40 the maximum saturation), and hº (hue, representing the dominant wavelength of a color on a continuous circular scale from 0° to 360°).
Color changes between visits will be calculated using the CIELab, CIEDE2000, and White Index for Dentistry (WID) formulas.
Color measurements will be recorded at the following time points:
- Baseline (Bleaching Day 1)
- One week after baseline (Before Bleaching Day 2)
- Follow-up (One week after)
Measured: Baseline (Bleaching Day 1), 1 week later baseline (Before Bleaching day 2), Revision (One week after second bleaching session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start15 May 2025
- Primary completion16 Jul 2025
- Study completion16 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensitivity, ToothStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Triple-Blind, Clinical Trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Pereira-Lores, University of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355647
- Sponsor's protocol ID
- 2025/01
- Status last verified
- Jan 2026
- First submitted
- 10 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Triple Blind Randomized Clinical Trial Comparing the Efficacy of a Desensitizing Agent Used With an In-Office Bleaching Technique
- ClinicalTrials.gov ID
- NCT07355647
- Acronym / sponsor ID
- 2025/01
- Conditions
- Sensitivity, Tooth
- Keywords
- Tooth Bleaching, In-Office Bleaching, Desensitizing Agents, Tooth Sensitivity
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 16 Jul 2025 (actual)
- Study completion
- 16 Jul 2025 (actual)
- First posted
- 21 Jan 2026 (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 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.
Detailed description
- Visit 1: Study information and delivery of informed consent. Recording of patient's medical history, general examination, and prophylaxis. Alginate impressions will be taken of the upper and lower arches for all the patients who meet the inclusion criteria. The impressions will be poured into plaster, and individualized trays will be made for each patient. A positioning guide-finder tray will be fabricated for each patient for color measurement.
- Visit 2: Initial color measurement with a spectrophotometer and the positioning guide. Each patient will receive their individualized tray. A blinded clinical will put inside the trays the desensitizing agent (UltraEZ, Ultradent Products Inc.,South Jordan, UT,USA) or placebo. The patients had to wear it for 30 minutes. Then after a correct isolation the clinicians apply over the buccal surface from premolar to premolar of both arches the bleaching agent (Opalescence Boost 40%, Ultradent Products, South Jordan, USA).Two application of 20 minutes each. The sensitivity was recorded and patient were given a sensitivity test to record at home.
- Visit 3: One week after the first bleaching session. Color measurement with a spectrophotometer and the positioning guide. In this visit the second bleaching session was done with the same steps as visit 2.
- Visit 4: 15 days after the second bleaching session. Final data collection (color + patients sensitivity test)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Triple-Blind, Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| UltraEZ Group | Experimental | Drug: UltraEZA 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 |
| Placebo Group | Placebo comparator | Drug: PlaceboA 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- No oral os systemic pathology
- Periodontally Healthy
- No cavities
- Tooth shade of the canines A2 or darker
Key exclusion criteria (5 listed)
- Adhesive restorations or protheses in the anterior region
- Enamel or dentin alterations
- Smoking habits
- Pregnant women
- Undergone prior bleaching treatment
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 |
|---|---|---|
| UltraEZGeneral 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 | Drug | UltraEZ Group |
| PlaceboGeneral 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 | Drug | Placebo Group |
Primary outcome
Questionary of dental sensitivity
Time frame: Perioperative, 1 hour postoperative, 24 hours postoperative, 48 hours postoperative
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
1 secondary outcome
Color evaluation of each patient
Time frame: Baseline (Bleaching Day 1), 1 week later baseline (Before Bleaching day 2), Revision (One week after second bleaching session)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing UltraEZ in people with Sensitivity, Tooth, run by University of Santiago de Compostela 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 21 Jan 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Questionary of dental sensitivity (time frame: Perioperative, 1 hour postoperative, 24 hours postoperative, 48 hours postoperative). 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 21 Jan 2026.