At-home Bleaching Using Clear Aligners

Gingivitis Clinical Trial

Official title:

At-home Bleaching With the Use of Clear Aligners: Randomized Single-blind Equivalence Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05835453
• Other study ID #: IGiraldezdeLuis
• Status: Recruiting
• Phase: N/A
• Start date: April 14, 2023
• Est. completion date: June 10, 2024

Study information

• Verified date: September 2023
• Source: Universidad Rey Juan Carlos
• Contact: Isabel Giráldez, PhD
• Phone: +34669119781
• Email: isabel.giraldez[@]urjc.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the present project is to clinically evaluate the bleaching effectiveness, tooth sensitivity, gingival irritation and patient´s satisfaction during a at-home bleaching with 10% carbamide peroxide using a conventional bleaching tray or a clear aligner.

Description:

Forty patients (n=40) will be randomized as to which side will receive the type of bleaching tray, conventional or clear aligner. The at-home bleaching will be performed with 10% carbamide peroxide (Opalescence PF 10%) for 2 hours for 4 weeks. The color will be assessed at baseline, after one, two, four weeks, and at 1 month after bleaching treatment using subjective color guides (VITA Classical and VITA Bleachguide 3D-MASTER) and a objective digital spectrophotometer (VITA Easyshade). The intensity and absolute risk of tooth sensitivity and gingival irritation will also be determined with a visual analog scale (EVA 0-10). Patient´s satisfaction will be evaluated at baseline, after one and two weeks, and at 1 month after bleaching treatment with an apropriate questionnaire using a visual analog scale (EVA 0-10). Color change between groups will be compared by paired Student´s t-test. The absolute risk of tooth sensitivity and gingival irritation for both groups will be compared by McNemar test. Also, odds ratios, confidence intervals, and Spearman correlation will be determined. The intensity of tooth sensitivity, gingival irritation and patient´s satisfaction will be compared by paired Student´s t-test. The level of statistical significance accepted will be 5% for all analyses.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 10, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

The inclusion criteria will be the following:

• Patients over 18 years of age.
• 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 rinses. Patients with recessions without sensitivity are included.
• Absence of sensitivity, measured based on stimulation with the air from the syringe.
• Patients who are at least in A2-A3 color (Vita Classic Guide)

The exclusion criteria will be the following:

• Patients who have previously undergone whitening (less than 5 years).
• Patients undergoing orthodontic treatment.
• Patients with white spot or developmental alterations (dentinogenesis imperfecta, amelogenesis imperfecta) or with stains (tetracyclines or fluorosis).
• Patients with a history of trauma to anterior teeth.
• Patients who require internal whitening.
• Smokers.
• Pregnant or lactating women.
• Allergy to any component of whitening.
• Alterations of the oral mucosa (desquamative gingivitis, OLP, leukoplakias, etc.).
• 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

• Dentin Sensitivity
• Gingivitis
• Hypersensitivity
• Satisfaction, Patient
• Tooth Discoloration
• Tooth Sensitivity

Intervention

Other:
• Whitening
Two syringes of 10% carbamide peroxide bleaching gel will be provided for use with each type of tray. Volunteers will be instructed to use the whitening gel once a day for 2 hours, for 3 days per week with each tray, completing a total of 4 weeks of whitening procedure.

Locations

Country	Name	City	State
Spain	Clínica Dental Iturralde	Tafalla	Navarra

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Almeida LC, Riehl H, Santos PH, Sundfeld ML, Briso AL. Clinical evaluation of the effectiveness of different bleaching therapies in vital teeth. Int J Periodontics Restorative Dent. 2012 Jun;32(3):303-9. — View Citation

Carneiro TS, Favoreto MW, Bernardi LG, Sutil E, Wendlinger M, Centenaro GG, Reis A, Loguercio AD. Gingival irritation in patients submitted to at-home bleaching with different cutouts of the bleaching tray: a randomized, single-blind clinical trial. Clin Oral Investig. 2022 Jun;26(6):4381-4390. doi: 10.1007/s00784-022-04401-4. Epub 2022 Feb 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Color change evaluation	The color will be assessed using subjective color guides (VITA Classical and VITA Bleachguide 3D-MASTER) and a objective digital spectrophotometer (VITA Easyshade).	Baseline, after one, two, four weeks, and at 1 month after bleaching treatment
Secondary	Intensity and absolute risk of tooth sensitivity	They will be determined by means of a visual analog scale (EVA), using a conventional bleaching tray or a clear aligner, during at home bleaching treatment with 10% carbamide peroxide.	Baseline, after one, two, four weeks, and at 1 month after bleaching treatment
Secondary	Intensity and absolute risk of gingival irritation	They will be determined by means of a visual analog scale (EVA), using a conventional bleaching tray or a clear aligner, during at home bleaching treatment with 10% carbamide peroxide.	Baseline, after one, two, four weeks, and at 1 month after bleaching treatment
Secondary	Patient´s satisfaction	It will be measured with a questionnaire using a visual analog scale (EVA), when a conventional bleaching tray or a clear aligner is used to perform a at home bleaching treatment with 10% carbamide peroxide.	Baseline, after one, two, four weeks, and at 1 month after bleaching treatment