Gingival InflammationEarly Phase 1NCT06371664
Gingival Irritation Due to Bleaching Tray Design in an At-home Bleaching Treatment
A Early Phase 1 study testing Conventional Tray (1 mm) and Extended Tray (3 mm) in people with Gingival Inflammation, run by University of Santiago de Compostela at 1 site in Spain.
Trial summary
The primary aim of this study is to assess whether the design of the bleaching tray used in at-home bleaching treatment is directly correlated with the risk of gingival irritation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Inflammation
- What is being tested?
- Conventional Tray (1 mm) and Extended Tray (3 mm)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2023to 5 Apr 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No oral or systemic pathology
- Periodontally healthy
- No cavities
- Tooth shade of the upper and lower canines A2 or darker
Who cannot join
- Adhesive restorations or prostheses in the anterior region
- Enamel or dentin alterations
- Smoking
- 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: Does the Use of a 3-mm Extended Tray During an At-home Bleaching Treatment Increases Gingival Irritation Associated With This Procedure in an Adult Patient: Randomized Clinical Trial
The primary aim of this study is to assess whether the design of the bleaching tray used in at-home bleaching treatment is directly correlated with the risk of gingival irritation. Additionally, it aims to investigate whether the design influences the likelihood of dental sensitivity and its impact on the degree of tooth whitening.
Read the detailed description
Visit 1: Study information and delivery of informed consent. Recording of the patient's medical history, general examination, and prophylaxis. Alginate impressions will be taken of the upper and lower arches for all patients who meet the inclusion criteria. The impressions will be poured into plaster, and individualized bleaching trays will be made for each patient according to the predetermined assignment ( 1mm extended or 3 mm extended bleaching tray). A positioning guide tray will be fabricated for color measurement.
Visit 2: Initial color measurement with a spectrophotometer and the positioning guide. Each patient will receive their individualized trays. Additionally, they will be given 3 syringes of bleaching agent (Opalescence 16%, Ultradent Products). Each patient will be provided with an instruction sheet and recording sheets to fill out daily during the 3-week study period. They will record if they had gingival irritation and the degree of dental sensitivity.
Visit 3: First-week bleaching review. Data collection (gingival irritation + color + sensitivity).
Visit 4: Second-week bleaching review. Data collection (gingival irritation + color + sensitivity).
Visit 5: Third-week bleaching review and end of the study. Data collection (gingival irritation + color + sensitivity).
- Conditions
- Gingival Inflammation
- Being tested
- Conventional Tray (1 mm), Extended Tray (3 mm)
- Keywords
- Tooth bleaching, Vital Bleaching, At-Home bleaching, Gingival Irritation, Bleaching tray
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Tray (1 mm)Drug
General examination with bite-wings. Dental prophylaxis (dental scaling and polishing with an abrasive paste). Alginate impressions of both arches. Creation of conventional individualized bleaching trays (trimmed 1 mm above the gingival margin) and a position-finder tray of both arches. Application of the bleaching gel in the bleaching trays during 6-8 hours
Extended Tray (3 mm)Drug
General examination with bite-wings. Dental prophylaxis (dental scaling and polishing with an abrasive paste). Alginate impressions of both arches. Creation of extended individualized bleaching trays (trimmed 3 mm above the gingival margin) and a position-finder tray of both arches. Application of the bleaching gel in the bleaching trays during 6-8 hours
| Study group | Role | What they receive |
|---|---|---|
| Conventional Tray (1 mm) | Placebo comparator | Patients put in their individualized 1 mm bleaching trays the bleaching treatment every day during three weeks. Receives: Drug: Conventional Tray (1 mm) |
| Extended Tray (3 mm) | Experimental | Patients put in their individualized 3 mm bleaching trays the bleaching treatment every day during three weeks. Receives: Drug: Extended Tray (3 mm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective questionnaire of gingival irritation
Patients should answer daily a dental sensitivity questionnaire. They should mark a "0" if their gingival tissue appeared normal or a "1" If they observed GI, defined as the presence of a white or red layer on the gingiva.Patients who scored "0" during the treatment were classified as individuals without gingival irritation.
Measured: Daily, during 3 weeks
Objective clinical examination of gingival irritation
Clinicians examined visually and with a periodontal probe the gingival tissue.Patients were categorized according to Löe and Silness' gingival index as: G0 (normal gingiva); G1(mild inflammation: slight change in color, slight edema; no bleeding on probing); G2 (moderate inflammation: redness, edema and glazing; bleeding on probing); and G3 (severe inflammation: marked redness and edema; ulceration; tendency to spontaneous bleeding).Patients will a score of 0 during the treatment will be defined as patients with no gingival irritation. The individual highest recorded score will be the grade of gingival irritation.
Measured: Once a week, during 3 weeks
Secondary outcomes (2)
Questionnaire of dental sensitivity
Patients should answer a dental sensitivity questionnaire. A a 5-point subjective numerical classification scale will be used (0=no sensitivity, 1=light, 2=mild, 3=considerable and 4=severe). Patients will a score of 0 during the treatment will be defined as patients with no sensitivity. The individual highest recorded score will be the grade of intensity for each patient.
Measured: Daily, during 3 weeks
Shade evaluation with a dental spectrophotometer
The color will be measured with a dental spectrophotometer and the parameters L (Lightness), C (Chroma) and H (Hue) will be recorded. To determine the color change between visits the CIEDE2000 formula will be used.
Measured: Once a week, during 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Mar 2023
- Primary completion5 Apr 2023
- Study completion5 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gingival InflammationStudies 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
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 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
- NCT06371664
- Sponsor's protocol ID
- 2023/02
- Status last verified
- Apr 2024
- First submitted
- 14 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pereira-Lores P, Martin-Gonzalez J, Gancedo-Gancedo T, Alonso de la Pena V, Alvarez-Novoa P, Varela-Aneiros I, Abella-Sans F, Martin-Biedma B, Castelo-Baz P. Does the use of a 3-mm extended tray during an at-home bleaching treatment increase gingival irritation? A randomized clinical trial. J Prosthet Dent. 2025 May;133(5):1277-1283. doi: 10.1016/j.prosdent.2024.09.029. Epub 2024 Nov 18.
PubMed 39562219
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Use of a 3-mm Extended Tray During an At-home Bleaching Treatment Increases Gingival Irritation Associated With This Procedure in an Adult Patient: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06371664
- Acronym / sponsor ID
- 2023/02
- Conditions
- Gingival Inflammation
- Keywords
- Tooth bleaching, Vital Bleaching, At-Home bleaching, Gingival Irritation, Bleaching tray
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 5 Apr 2023 (actual)
- Study completion
- 5 Apr 2023 (actual)
- First posted
- 17 Apr 2024 (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 primary aim of this study is to assess whether the design of the bleaching tray used in at-home bleaching treatment is directly correlated with the risk of gingival irritation. Additionally, it aims to investigate whether the design influences the likelihood of dental sensitivity and its impact on the degree of tooth whitening.
Detailed description
Visit 1: Study information and delivery of informed consent. Recording of the patient's medical history, general examination, and prophylaxis. Alginate impressions will be taken of the upper and lower arches for all patients who meet the inclusion criteria. The impressions will be poured into plaster, and individualized bleaching trays will be made for each patient according to the predetermined assignment ( 1mm extended or 3 mm extended bleaching tray). A positioning guide tray will be fabricated for color measurement.
Visit 2: Initial color measurement with a spectrophotometer and the positioning guide. Each patient will receive their individualized trays. Additionally, they will be given 3 syringes of bleaching agent (Opalescence 16%, Ultradent Products). Each patient will be provided with an instruction sheet and recording sheets to fill out daily during the 3-week study period. They will record if they had gingival irritation and the degree of dental sensitivity.
Visit 3: First-week bleaching review. Data collection (gingival irritation + color + sensitivity).
Visit 4: Second-week bleaching review. Data collection (gingival irritation + color + sensitivity).
Visit 5: Third-week bleaching review and end of the study. Data collection (gingival irritation + color + sensitivity).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, triple-blind clinical trial
| Arm | Type | Receives |
|---|---|---|
| Conventional Tray (1 mm) | Placebo comparator | Drug: Conventional Tray (1 mm)Patients put in their individualized 1 mm bleaching trays the bleaching treatment every day during three weeks. |
| Extended Tray (3 mm) | Experimental | Drug: Extended Tray (3 mm)Patients put in their individualized 3 mm bleaching trays the bleaching treatment every day during three weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- No oral or systemic pathology
- Periodontally healthy
- No cavities
- Tooth shade of the upper and lower canines A2 or darker
Key exclusion criteria (5 listed)
- Adhesive restorations or prostheses in the anterior region
- Enamel or dentin alterations
- Smoking
- 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 |
|---|---|---|
| Conventional Tray (1 mm)General examination with bite-wings. Dental prophylaxis (dental scaling and polishing with an abrasive paste). Alginate impressions of both arches. Creation of conventional individualized bleaching trays (trimmed 1 mm above the gingival margin) and a position-finder tray of both arches. Application of the bleaching gel in the bleaching trays during 6-8 hours | Drug | Conventional Tray (1 mm) |
| Extended Tray (3 mm)General examination with bite-wings. Dental prophylaxis (dental scaling and polishing with an abrasive paste). Alginate impressions of both arches. Creation of extended individualized bleaching trays (trimmed 3 mm above the gingival margin) and a position-finder tray of both arches. Application of the bleaching gel in the bleaching trays during 6-8 hours | Drug | Extended Tray (3 mm) |
Primary outcome
Subjective questionnaire of gingival irritation
Time frame: Daily, during 3 weeks
Patients should answer daily a dental sensitivity questionnaire. They should mark a "0" if their gingival tissue appeared normal or a "1" If they observed GI, defined as the presence of a white or red layer on the gingiva.Patients who scored "0" during the treatment were classified as individuals without gingival irritation.
Objective clinical examination of gingival irritation
Time frame: Once a week, during 3 weeks
Clinicians examined visually and with a periodontal probe the gingival tissue.Patients were categorized according to Löe and Silness' gingival index as: G0 (normal gingiva); G1(mild inflammation: slight change in color, slight edema; no bleeding on probing); G2 (moderate inflammation: redness, edema and glazing; bleeding on probing); and G3 (severe inflammation: marked redness and edema; ulceration; tendency to spontaneous bleeding).Patients will a score of 0 during the treatment will be defined as patients with no gingival irritation. The individual highest recorded score will be the grade of gingival irritation.
2 secondary outcomes
Questionnaire of dental sensitivity
Time frame: Daily, during 3 weeks
Shade evaluation with a dental spectrophotometer
Time frame: Once a week, during 3 weeks
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 17 Apr 2024.
- Derived from this study: PubMed 39562219Pereira-Lores P, Martin-Gonzalez J, Gancedo-Gancedo T, Alonso de la Pena V, Alvarez-Novoa P, Varela-Aneiros I, Abella-Sans F, Martin-Biedma B, Castelo-Baz P. Does the use of a 3-mm extended tray during an at-home bleaching treatment increase gingival irritation? A randomized clinical trial. J Prosthet Dent. 2025 May;133(5):1277-1283. doi: 10.1016/j.prosdent.2024.09.029. Epub 2024 Nov 18.
- 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 Conventional Tray (1 mm) and Extended Tray (3 mm) in people with Gingival Inflammation, 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 17 Apr 2024. 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?
Subjective questionnaire of gingival irritation (time frame: Daily, during 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06371664, which also lists 1 linked publication.
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 17 Apr 2024.