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

Primary Purpose

Discoloured Teeth

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Philips Zoom! White Speed whitening lamp
Philips Zoom! Advanced power whitening lamp
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Discoloured Teeth focused on measuring post bleaching teeth sensitivity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • British Unibersity in Egypt

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Philips Zoom! White Speed whitening lamp

Philips Zoom! Advanced power lamp

Arm Description

Philips Zoom! White Speed whitening lamp

Philips Zoom! Advanced power whitening lamp

Outcomes

Primary Outcome Measures

post bleaching teeth sensitivity

Secondary Outcome Measures

Full Information

First Posted
August 31, 2016
Last Updated
August 7, 2019
Sponsor
Cairo University
Collaborators
British University In Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT02888847
Brief Title
High Light Intensity Bleaching Versus Descending Light Intensities Bleaching on Post Bleaching Teeth Sensitivity
Official Title
Effect of High Light Intensity Bleaching Protocol Versus Descending Light Intensities Bleaching Protocol on Post Bleaching Teeth Sensitivity: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 10, 2017 (Actual)
Primary Completion Date
October 10, 2018 (Actual)
Study Completion Date
November 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
British University In Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Discoloured Teeth
Keywords
post bleaching teeth sensitivity

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Philips Zoom! White Speed whitening lamp
Arm Type
Active Comparator
Arm Description
Philips Zoom! White Speed whitening lamp
Arm Title
Philips Zoom! Advanced power lamp
Arm Type
Sham Comparator
Arm Description
Philips Zoom! Advanced power whitening lamp
Intervention Type
Device
Intervention Name(s)
Philips Zoom! White Speed whitening lamp
Intervention Description
bleaching protocol with descending built in light intensities
Intervention Type
Device
Intervention Name(s)
Philips Zoom! Advanced power whitening lamp
Intervention Description
bleaching protocol with high light intensity
Primary Outcome Measure Information:
Title
post bleaching teeth sensitivity
Time Frame
after 1 week

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients included in this clinical trial were at least18 years old. Patients should be free from any systemic disease that may affect normal healing and predictable outcome. Patients who will agree to the consent and will commit to follow-up period. 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: Patients with any systemic disease that may affect normal healing. Patient with bad oral hygiene. Pregnant females. Patients who could/would not participate in a 3month follow-up. Untreated periodontal disease were not allowed. Active caries or defective Restorations in 6 anterior teeth. Sensitive Teeth Bleaching history Patients participating in more than 1 dental study.
Facility Information:
Facility Name
British Unibersity in Egypt
City
Cairo
ZIP/Postal Code
11837
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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