Tooth BleachingNCT02942082
Clinical Evaluation for Post Bleaching Hypersensitivity Using Desensitizing Agent During In-office Bleaching
A study testing ACP oral care gel and glycrin in people with Tooth Bleaching, run by Cairo University at 1 site in Egypt.
Trial summary
Evaluating the effect of a desensitizing agent on post-bleaching hypersensitivity. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Bleaching
- What is being tested?
- ACP oral care gel and glycrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2017to 29 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients must show no signs of spontaneous dental pain.
- Male or female patients between the ages of 18 to 40.
- Patients with good general and oral health.
- Patients having six caries-free maxillaryanterior teeth without restorations on the labial surfaces.
- Patients should have central incisors determined to be shade C2 or darker
Who cannot join
- Patient with spontaneous dental pain.
- Patient with anterior restorations or non carious cervical lesion.
- Patient having severe internal tooth discoloration (tetracycline stains, fluorosis, pulpless teeth), and bruxism habits.
- Tempro-mandibular joint problems involving symptomatic pain.
- Patients taking analgesics that could alter their normal pain perception level.
- Pregnant or breast feeding women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation for Post Bleaching Hypersensitivity Using Desensitizing Agent Before and /or After In-office Bleaching
Evaluating the effect of a desensitizing agent on post-bleaching hypersensitivity.
Read the detailed description
A randomized clinical trail will be done to evaluate the effect of a desensitizing agent ACP oral care gel in comparison to a control group on hypersensitivity after bleaching using a visual analogue scale.
- Conditions
- Tooth Bleaching
- Being tested
- ACP oral care gel, glycrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACP oral care gelOther
a desensitizing agent will be applied on tooth before and/or after bleaching
glycrinOther
glycrin will be applied on tooth surface before and/or after bleaching
| Study group | Role | What they receive |
|---|---|---|
| ACP oral care geldesensitizing agent | Experimental | a desensitizing agent will be applied on tooth before and /or after bleaching. Receives: Other: ACP oral care gel |
| glycrin | Placebo comparator | glycrin will be applied on tooth before and /or after bleaching. Receives: Other: glycrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-bleaching hypersensitivity assessed using visual analogue scale
using visual analogue scale
Measured: one month
Secondary outcomes (1)
Tooth color assessed using value-ordered VITA® Classical Shade Guide
value-ordered VITA® Classical Shade Guide
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study start1 Nov 2017
- Primary completion1 Sep 2018
- Study completion29 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth BleachingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Sabry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942082
- Sponsor's protocol ID
- CEBD-CU-2016-10-222
- Status last verified
- Sep 2019
- First submitted
- 19 Oct 2016
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation for Post Bleaching Hypersensitivity Using Desensitizing Agent Before and /or After In-office Bleaching
- ClinicalTrials.gov ID
- NCT02942082
- Acronym / sponsor ID
- CEBD-CU-2016-10-222
- Conditions
- Tooth Bleaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 29 Nov 2018 (actual)
- First posted
- 21 Oct 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.
Evaluating the effect of a desensitizing agent on post-bleaching hypersensitivity.
Detailed description
A randomized clinical trail will be done to evaluate the effect of a desensitizing agent ACP oral care gel in comparison to a control group on hypersensitivity after bleaching using a visual analogue scale.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACP oral care geldesensitizing agent | Experimental | Other: ACP oral care gela desensitizing agent will be applied on tooth before and /or after bleaching. |
| glycrin | Placebo comparator | Other: glycringlycrin will be applied on tooth before and /or after bleaching. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients must show no signs of spontaneous dental pain.
- Male or female patients between the ages of 18 to 40.
- Patients with good general and oral health.
- Patients having six caries-free maxillaryanterior teeth without restorations on the labial surfaces.
- Patients should have central incisors determined to be shade C2 or darker
Key exclusion criteria (6 listed)
- Patient with spontaneous dental pain.
- Patient with anterior restorations or non carious cervical lesion.
- Patient having severe internal tooth discoloration (tetracycline stains, fluorosis, pulpless teeth), and bruxism habits.
- Tempro-mandibular joint problems involving symptomatic pain.
- Patients taking analgesics that could alter their normal pain perception level.
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 |
|---|---|---|
| ACP oral care gela desensitizing agent will be applied on tooth before and/or after bleaching | Other | ACP oral care geldesensitizing agent |
| glycringlycrin will be applied on tooth surface before and/or after bleaching | Other | glycrin |
Primary outcome
Post-bleaching hypersensitivity assessed using visual analogue scale
Time frame: one month
using visual analogue scale
1 secondary outcome
Tooth color assessed using value-ordered VITA® Classical Shade Guide
Time frame: one month
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 18 Sep 2019.
- Individual participant dataSharing planned: No
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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 ACP oral care gel and glycrin in people with Tooth Bleaching, 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 5 inclusion and 6 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 18 Sep 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 hypersensitivity assessed using visual analogue scale (time frame: one month). 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 18 Sep 2019.