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

August 7, 2019 updated by: Shadwa Hatem Saad Kabil, Cairo University

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

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.).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11837
        • British Unibersity in Egypt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Philips Zoom! White Speed whitening lamp
Device: Philips Zoom! White Speed whitening lamp
bleaching protocol with descending built in light intensities
Sham Comparator: Philips Zoom! Advanced power lamp
Philips Zoom! Advanced power whitening lamp
Device: Philips Zoom! Advanced power whitening lamp
bleaching protocol with high light intensity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
post bleaching teeth sensitivity
Time Frame: after 1 week
after 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Collaborators

British University In Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2017

Primary Completion (Actual)

October 10, 2018

Study Completion (Actual)

November 10, 2018

Study Registration Dates

First Submitted

August 31, 2016

First Submitted That Met QC Criteria

August 31, 2016

First Posted (Estimate)

September 5, 2016

Study Record Updates

Last Update Posted (Actual)

August 9, 2019

Last Update Submitted That Met QC Criteria

August 7, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBD-CU-2016-08-195

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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