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

Dental Hypersensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06035588
• Other study ID #: URJC University
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2023
• Est. completion date: June 17, 2024

Study information

• Verified date: September 2023
• Source: Universidad Rey Juan Carlos
• Contact: ISABEL GIRALDEZ DE LUIS, Lecturer
• Phone: 669119781
• Email: isabel.giraldez[@]urjc.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: June 17, 2024
• Est. primary completion date: October 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dental Hypersensitivity
• Hypersensitivity
• Teeth Whitening

Intervention

Other:
• Daily whitening
Daily application of a 16% carbamide peroxide bleaching gel in volunteers without sensitivity.
• Alternate whitening
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.

Locations

Country	Name	City	State
Spain	Isabel Giraldez de Luis	Alcorcón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Cardoso PC, Reis A, Loguercio A, Vieira LC, Baratieri LN. Clinical effectiveness and tooth sensitivity associated with different bleaching times for a 10 percent carbamide peroxide gel. J Am Dent Assoc. 2010 Oct;141(10):1213-20. doi: 10.14219/jada.archive.2010.0048. — View Citation

Chagas AS, Freitas KMS, Cancado RH, Valarelli FP, Canuto LFG, Oliveira RCG, Oliveira RCG. Level of satisfaction in the use of the wraparound Hawley and thermoplastic maxillary retainers. Angle Orthod. 2020 Jan;90(1):63-68. doi: 10.2319/031319-197.1. Epub 2019 Jul 22. — View Citation

de Geus JL, Wambier LM, Boing TF, Loguercio AD, Reis A. At-home Bleaching With 10% vs More Concentrated Carbamide Peroxide Gels: A Systematic Review and Meta-analysis. Oper Dent. 2018 Jul/Aug;43(4):E210-E222. doi: 10.2341/17-222-L. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gingival irritation	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.	3 weeks
Other	Patient's oral quality of life	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.	1 month
Primary	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.	3 weeks
Secondary	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.	1 month