High Light Intensity Bleaching Versus Descending Light Intensities Bleaching on Post Bleaching Teeth Sensitivity

Discoloured Teeth Clinical Trial

Official title:

Effect of High Light Intensity Bleaching Protocol Versus Descending Light Intensities Bleaching Protocol on Post Bleaching Teeth Sensitivity: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02888847
• Other study ID #: CEBD-CU-2016-08-195
• Status: Completed
• Phase: N/A
• Start date: September 10, 2017
• Est. completion date: November 10, 2018

Study information

• Verified date: August 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Compare teeth sensitivity using bleaching protocol with different light intensities (Philips Zoom!™ White Speed whitening gel and lamp, Discus Dental, Inc., Culver City, CA, USA.) versus bleaching protocol with the same light intensity (Philips Zoom!™ Advanced Power whitening gel and lamp, Discus Dental, Inc., Culver City, CA, USA.).

Description:

This study will be applied to patients suffering from teeth discolorations. Nowadays, vital tooth bleaching is one of the most requested cosmetic dental procedures asked by patients who want and aesthetically more pleasing smile. The American Dental Association (ADA) has advised patients to ask the dentists to adamant the most suitable bleaching treatment, especially for those complaining of tooth sensitivity, dental restorations, extremely dark discolorations, and single dark teeth.

Tooth sensitivity (TS) is the most common clinical side effect of tooth bleaching. Tooth sensitivity (TS) caused by bleaching procedures usually results in mild and transient pain; however, it can occasionally cause significant discomfort that is a main deterrent to patients successfully completing bleaching treatments. Considering that TS has been reported as a common side effect, affecting more than 60% of the patients that undergo this cosmetic treatment. Greater tooth sensitivity has been reported with in-office bleaching with adjunct light compared with no light. Existing literature reveals that activation of bleaching agents by heat or light may have an adverse effect on pulpal tissue. It was already reported that the use of intense lights does elevate bleach temperature, but it results in increased intrapulpal temperatures, which may further impact patient sensitivity and pulpal health.Hence, in this study different light intensities bleaching protocol will be used aiming at overcoming this complication.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 10, 2018
• Est. primary completion date: October 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Patients included in this clinical trial were at least18 years old.

2. Patients should be free from any systemic disease that may affect normal healing and predictable outcome.

3. Patients who will agree to the consent and will commit to follow-up period.

4. Willing to refrain from tobacco products and any colored liquids or food (e.g. coffee, tea, tomato sauce etc.) during the active study period.

Exclusion Criteria:

1. Patients with any systemic disease that may affect normal healing.

2. Patient with bad oral hygiene.

3. Pregnant females.

4. Patients who could/would not participate in a 3month follow-up.

5. Untreated periodontal disease were not allowed.

6. Active caries or defective Restorations in 6 anterior teeth.

7. Sensitive Teeth

8. Bleaching history

9. Patients participating in more than 1 dental study.

Related Conditions & MeSH terms

• Dentin Sensitivity
• Discoloured Teeth
• Hypersensitivity
• Tooth Discoloration

Intervention

Device:
• Philips Zoom! White Speed whitening lamp
bleaching protocol with descending built in light intensities
• Philips Zoom! Advanced power whitening lamp
bleaching protocol with high light intensity

Locations

Country	Name	City	State
Egypt	British Unibersity in Egypt	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Cairo University	British University In Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post bleaching teeth sensitivity		after 1 week