Efficacy in the Reduction of Hypersensitivity During Home Whitening With 16% Carbamide Peroxide Applied on Alternate Days

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Daily whitening

Alternate whitening

About this trial

This is an interventional treatment trial for Dental Hypersensitivity focused on measuring bleaching, hipersensitivity, whitening, at-home, carbamide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients older than 18 years. Patients with vital teeth without restorations, single crowns, implants and/or bridges at the level of the anterior teeth. Absence of cavities in the teeth to be whitened. Patients with satisfactory oral hygiene and periodontally healthy, who are not undergoing periodontal maintenance and who do not use chlorhexidine mouthwashes. Patients with recessions without presenting sensitivity will be included. Absence of sensitivity, measured with the application of air with the dental team's syringe. Patients whose canines have at least an A2-A3 shade (VITA Classic® Guide). Exclusion Criteria: Patients who have previously undergone whitening (less than 5 years). Patients undergoing orthodontic treatment. Patients with white spots or alterations in the development of enamel or with stains. Patients with a history of trauma to anterior teeth. Patients who require internal whitening. Smokers. Pregnant or lactating. Patients with allergies to any whitening component. Patients presenting alterations of the oral mucosa (desquamative gingivitis, oral lichen planus, leukoplakia, etc.). Patients with medical conditions considered by the researchers that may compromise the study or the individual safety of the patient. Patients with poor oral hygiene. Patients with previous hypersensitivity.

Sites / Locations

Isabel Giraldez de LuisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Daily whitening

Alternate whitening

Arm Description

Volunteers should whiten daily with a whitening tray from 15 to 25 and 35 to 45 for 2 hours. This procedure will last 3 weeks.

Volunteers will bleach for 3 weeks with 16% carbamide peroxide, alternating one rest day for each placement day. They will wear a whitening tray from 15 to 25 and from 35 to 45 for 2 hours.

Outcomes

Primary Outcome Measures

Dental Sensitivity

The objective of the study is to clinically evaluate the appearance of dental sensitivity produced by the home dental whitening treatment using 16% carbamide peroxide applied in a tray for two hours daily each day or using it on alternate days for three weeks.

Secondary Outcome Measures

whitening efficacy

To assess whether the efficacy of the 16% carbamide peroxide whitening treatment described above applied every other day is the same as when used every day or is there a difference in whitening efficacy. This will be determined instrumentally with the Vita EasyShade V® spectrophotometer, based on the CIEL*a*b* system, according to the CIELAB, CIEDE2000 system and the whiteness index.

Full Information

NCT ID

NCT06035588

First Posted

September 6, 2023

Last Updated

September 12, 2023

Sponsor

Universidad Rey Juan Carlos

1. Study Identification

Unique Protocol Identification Number

NCT06035588

Brief Title

Efficacy in the Reduction of Hypersensitivity During Home Whitening With 16% Carbamide Peroxide Applied on Alternate Days

Official Title

Efficacy in the Reduction of Hypersensitivity During Home Whitening With 16% Carbamide Peroxide Applied on Alternate Days: a Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 6, 2023 (Anticipated)

Primary Completion Date

October 27, 2023 (Anticipated)

Study Completion Date

June 17, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad Rey Juan Carlos

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The concentration of 16% carbamide peroxide is the highest concentration that European regulations allow for use in home whitening (Council directive 2011/84/EU). This concentration allows for faster results, but instead patients may suffer more frequently from dental sensitivity. The most commonly described side effect of all whitening procedures is the appearance of dentin hypersensitivity, hence the efforts to counteract or overcome this adverse effect. The objective of the study is to clinically evaluate the difference in dental hypersensitivity produced by home dental whitening treatment using 16% carbamide peroxide in a tray for two hours daily applied daily or every other day for three weeks.

Detailed Description

Volunteers will be instructed to use the whitening gel once a day for 2 hours, completing a total of 3 weeks of whitening procedure. Depending on the randomization, the bleaching procedure will be performed every other day or daily. In the upper arch, the teeth to be whitened will be from 15 to 25. The evaluations of efficacy, dental sensitivity and satisfaction will be carried out in the upper and lower arch. The color will be recorded before, weekly for 1 month, 6 months and 12 months after finishing the treatment. Shade assessment using the subjective method will be recorded with the Vita Classical color scale (Vita Zahnfabrik, Bad Säckingen, Germany), it will also be determined with the Vita 3D-MASTER scale (Vita Zahnfabrik, Bad Säckingen, Germany). For objective evaluation, the Vita Easyshade spectrophotometer (Vita Zahnfabrik, Bad Säckingen, Germany) will be used, according to the CIEL*a*b* system.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Hypersensitivity, Teeth Whitening

Keywords

bleaching, hipersensitivity, whitening, at-home, carbamide

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Each volunteer will be given 3 syringes of 16% carbamide peroxide bleaching gel to use on the splint. Volunteers will be instructed to use the whitening gel once a day for 2 hours, completing a total of 3 weeks of whitening procedure. Depending on the randomization, the whitening procedure will be performed on alternate days or daily. In the upper arch, the teeth to be whitened will be from 15 to 25 and in the lower one from 35 to 45.

Masking

InvestigatorOutcomes Assessor

Masking Description

The present study presents blinding of both the evaluator and the person who will carry out the statistical analysis, and therefore double-blind. The evaluators are considered blind in this study because they do not know the randomization of the patients, being a blind study. The operator and patients know the groups in which they are assigned, due to the delivery and placement of the splints. A block randomization of the treatment applied to the patients will be carried out, to ensure that the sample size is similar in both groups. The operator will open an envelope for the group's allocation. The assignment of the groups will be carried out using opaque, sealed and sequentially numbered envelopes. The operator will open the envelope when the splints are delivered, and will give the pertinent explanations to the patient. Data will be collected from each patient that may influence treatment results such as age, sex, initial color, systemic pathologies and pharmacological treatments.

Allocation

Randomized

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Daily whitening

Arm Type

Active Comparator

Arm Description

Volunteers should whiten daily with a whitening tray from 15 to 25 and 35 to 45 for 2 hours. This procedure will last 3 weeks.

Arm Title

Alternate whitening

Arm Type

Experimental

Arm Description

Volunteers will bleach for 3 weeks with 16% carbamide peroxide, alternating one rest day for each placement day. They will wear a whitening tray from 15 to 25 and from 35 to 45 for 2 hours.

Intervention Type

Other

Intervention Name(s)

Daily whitening

Intervention Description

Daily application of a 16% carbamide peroxide bleaching gel in volunteers without sensitivity.

Intervention Type

Other

Intervention Name(s)

Alternate whitening

Intervention Description

Volunteers will apply the whitening gel at 16% carbamide peroxide, alternating a rest day with an application day. Patients should not be sensitive before starting the study.

Primary Outcome Measure Information:

Title

Dental Sensitivity

Description

The objective of the study is to clinically evaluate the appearance of dental sensitivity produced by the home dental whitening treatment using 16% carbamide peroxide applied in a tray for two hours daily each day or using it on alternate days for three weeks.

Time Frame

3 weeks

Secondary Outcome Measure Information:

Title

whitening efficacy

Description

To assess whether the efficacy of the 16% carbamide peroxide whitening treatment described above applied every other day is the same as when used every day or is there a difference in whitening efficacy. This will be determined instrumentally with the Vita EasyShade V® spectrophotometer, based on the CIEL*a*b* system, according to the CIELAB, CIEDE2000 system and the whiteness index.

Time Frame

1 month

Other Pre-specified Outcome Measures:

Title

Gingival irritation

Description

To compare the existence of gingival irritation using the Visual Analog Scale after the application of bleaching every two days with 16% carbamide peroxide, compared to the daily application.

Time Frame

3 weeks

Title

Patient's oral quality of life

Description

To assess the impact on the patient's oral quality of life (OHIP-14) in terms of treatment results using a questionnaire, after applying home whitening with 16% carbamide peroxide every other day, instead of applying it daily.

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients older than 18 years. Patients with vital teeth without restorations, single crowns, implants and/or bridges at the level of the anterior teeth. Absence of cavities in the teeth to be whitened. Patients with satisfactory oral hygiene and periodontally healthy, who are not undergoing periodontal maintenance and who do not use chlorhexidine mouthwashes. Patients with recessions without presenting sensitivity will be included. Absence of sensitivity, measured with the application of air with the dental team's syringe. Patients whose canines have at least an A2-A3 shade (VITA Classic® Guide). Exclusion Criteria: Patients who have previously undergone whitening (less than 5 years). Patients undergoing orthodontic treatment. Patients with white spots or alterations in the development of enamel or with stains. Patients with a history of trauma to anterior teeth. Patients who require internal whitening. Smokers. Pregnant or lactating. Patients with allergies to any whitening component. Patients presenting alterations of the oral mucosa (desquamative gingivitis, oral lichen planus, leukoplakia, etc.). Patients with medical conditions considered by the researchers that may compromise the study or the individual safety of the patient. Patients with poor oral hygiene. Patients with previous hypersensitivity.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

ISABEL GIRALDEZ DE LUIS, Lecturer

Phone

669119781

Email

isabel.giraldez@urjc.es

Facility Information:

Facility Name

Isabel Giraldez de Luis

City

Alcorcón

State/Province

Madrid

ZIP/Postal Code

28922

Country

Spain

Individual Site Status

Recruiting

Facility Contact: