Combined Dental Bleaching Protocols and Time Required to Achieve Satisfactory Color

Tooth Discoloration Clinical Trial

Official title:

Effect of a Single Prior Session of In-office Dental Bleaching on Time Required to Obtain Satisfactory Tooth Color With At-home Bleaching

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03514797
• Other study ID #: Combined bleaching
• Status: Completed
• Phase: Phase 4
• Start date: April 13, 2018
• Est. completion date: June 30, 2018

Study information

• Verified date: April 2019
• Source: Universidade Federal de Sergipe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This parallel, randomized, and controlled clinical trial will assess the effect of a single prior session of in-office dental bleaching on time required to achieve satisfactory tooth color with at-home bleaching. Participants enrolled will randomly allocated to receive or not a single session of dental bleaching with 35% hydrogen peroxide applied for 45 min. Following, all participants will use customized trays filled with 10% carbamide peroxide for 1h per day until obtain satisfactory results. The primary outcome will be the number of days necessary to obtain satisfactory tooth color. Furthermore, tooth sensitivity and color changes measured with spectrophotometer will be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Good general and oral health;

• Upper canines darker than the tab 2.5M2 at VITA Bleachedguide 3D-MASTER® (Vita-Zahnfabrik, Bad Sackingen, Germany) scale.

Exclusion Criteria:

• Presence of non-treated caries or periodontal disease;

• Prior tooth hypersensitivity;

• Presence of gingival recession;

• Teeth with cracked enamel or any hypoplasia;

• Patients using oral removable or fixed orthodontic appliances;

• Patients were pregnant or breastfeeding.

Related Conditions & MeSH terms

• Tooth Discoloration

Intervention

Drug:
• Bleaching Agents
In-office tooth bleaching with 35% hydrogen peroxide in a single application of 45 minutes.
• Bleaching Agents
At-home tooth bleaching with 10% carbamide peroxide for 1 hour per day.

Locations

Country	Name	City	State
Brazil	Universidade Federal de Sergipe	Aracaju	SE

Sponsors (1)

Lead Sponsor	Collaborator
André Luis Faria e Silva

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. — View Citation

Rezende M, Ferri L, Kossatz S, Loguercio AD, Reis A. Combined Bleaching Technique Using Low and High Hydrogen Peroxide In-Office Bleaching Gel. Oper Dent. 2016 Jul-Aug;41(4):388-96. doi: 10.2341/15-266-C. Epub 2016 Feb 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to tooth color satisfaction	Time in days performing at-home bleaching necessary to participant reports that is satisfied with the tooth color obtained	up to 1 month after beginning the tooth bleaching procedures
Secondary	Color change	Values of delta E measured with a spectrophotometer from color at baseline	up to 1 month after beginning the tooth bleaching procedures
Secondary	Tooth sensitivity	Maximum level of tooth sensitivity reported by participants using an analogue visual scale. The distance between the patient`s marking and the no pain border was recorded in cm.	1, 2, 3, and 4 week after beginning the tooth bleaching procedures