Discoloured TeethNCT02888847
High Light Intensity Bleaching Versus Descending Light Intensities Bleaching on Post Bleaching Teeth Sensitivity
A study testing Philips Zoom! White Speed whitening lamp and Philips Zoom! Advanced power whitening lamp in people with Discoloured Teeth, run by Cairo University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Discoloured Teeth
- What is being tested?
- Philips Zoom! White Speed whitening lamp and Philips Zoom! Advanced power whitening lamp
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2017to 10 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Sensitive Teeth
- Bleaching history
- Patients participating in more than 1 dental study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.).
Read the 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.
- Conditions
- Discoloured Teeth
- Being tested
- Philips Zoom! White Speed whitening lamp, Philips Zoom! Advanced power whitening lamp
- Keywords
- post bleaching teeth sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Philips Zoom! White Speed whitening lampDevice
bleaching protocol with descending built in light intensities
Philips Zoom! Advanced power whitening lampDevice
bleaching protocol with high light intensity
| Study group | Role | What they receive |
|---|---|---|
| Philips Zoom! White Speed whitening lamp | Active comparator | Philips Zoom! White Speed whitening lamp Receives: Device: Philips Zoom! White Speed whitening lamp |
| Philips Zoom! Advanced power lamp | Sham comparator | Philips Zoom! Advanced power whitening lamp Receives: Device: Philips Zoom! Advanced power whitening lamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
post bleaching teeth sensitivity
Measured: after 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study start10 Sep 2017
- Primary completion10 Oct 2018
- Study completion10 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Discoloured TeethStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- British University In Egypt
- Responsible party
- Principal investigator, Shadwa Hatem Saad Kabil, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888847
- Sponsor's protocol ID
- CEBD-CU-2016-08-195
- Status last verified
- Aug 2019
- First submitted
- 31 Aug 2016
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Light Intensity Bleaching Protocol Versus Descending Light Intensities Bleaching Protocol on Post Bleaching Teeth Sensitivity: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02888847
- Acronym / sponsor ID
- CEBD-CU-2016-08-195
- Conditions
- Discoloured Teeth
- Keywords
- post bleaching teeth sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- British University In Egypt
- Study start
- 10 Sep 2017 (actual)
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 10 Nov 2018 (actual)
- First posted
- 5 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Philips Zoom! White Speed whitening lamp | Active comparator | Device: Philips Zoom! White Speed whitening lampPhilips Zoom! White Speed whitening lamp |
| Philips Zoom! Advanced power lamp | Sham comparator | Device: Philips Zoom! Advanced power whitening lampPhilips Zoom! Advanced power whitening lamp |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Philips Zoom! White Speed whitening lampbleaching protocol with descending built in light intensities | Device | Philips Zoom! White Speed whitening lamp |
| Philips Zoom! Advanced power whitening lampbleaching protocol with high light intensity | Device | Philips Zoom! Advanced power lamp |
Primary outcome
post bleaching teeth sensitivity
Time frame: after 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Philips Zoom! White Speed whitening lamp and Philips Zoom! Advanced power whitening lamp in people with Discoloured Teeth, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post bleaching teeth sensitivity (time frame: after 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2019.