Tooth StainPhase 4NCT02682329
Combination of Dental Bleaching Techniques, Randomized Clinical Trial
A Phase 4 study testing Hydrogen Peroxide and Carbamide Peroxide and Hydrogen Peroxide and Hydrogen Peroxide in people with Tooth Stain, run by Universidad Iberoamericana.
Trial summary
To determine the effectiveness of combining different concentrations of hydrogen peroxide and carbamide used during tooth bleaching. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Stain
- What is being tested?
- Hydrogen Peroxide and Carbamide Peroxide and Hydrogen Peroxide and Hydrogen Peroxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Aug 2015
- Phase
- Phase 4
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 - 45 years old
- Student, teacher or administrative personnel at UNIBE.
Who cannot join
- Dental Hypersensitivity
- Periodontal disease
- Active caries lesions
- Allergy to latex
- Orthodontic treatment
About this study
To determine the effectiveness of combining different concentrations of hydrogen peroxide and carbamide used during tooth bleaching.
Read the detailed description
120 patiens over 18 years old.
Design:
Hydrogen peroxide (HP) Carbamide Peroxide (CP)
Group 1: CP 10% + HP 40% Group 2: CP 15% + HP 40% Group 3: CP 20% + HP 40% Group 4: HP 10% + HP 40%
- Conditions
- Tooth Stain
- Being tested
- Hydrogen Peroxide and Carbamide Peroxide, Hydrogen Peroxide and Hydrogen Peroxide
- Keywords
- Peroxide
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrogen Peroxide and Carbamide PeroxideOther
Carbamide Peroxide + Hydrogen Peroxide were administered to each patient on this group. HP 10% at home and HP 40% at office
Hydrogen Peroxide and Hydrogen PeroxideOther
Hydrogen Peroxide + Hydrogen Peroxide were administered to each patient on this group. HP at home and HP at office
| Study group | Role | What they receive |
|---|---|---|
| CP 10% + HP 40% | Active comparator | Carbamide Peroxide 10% + Hydrogen Peroxide 40% were administered to each patient on this group. CP at home and HP at office Receives: Other: Hydrogen Peroxide and Carbamide Peroxide |
| CP 15% + HP 40% | Active comparator | Carbamide Peroxide 15% + Hydrogen Peroxide 40% were administered to each patient on this group.CP at home and HP at office Receives: Other: Hydrogen Peroxide and Carbamide Peroxide |
| CP 20% + HP 40% | Active comparator | Carbamide Peroxide 20% + Hydrogen Peroxide 40% were administered to each patient on this group.CP at home and HP at office Receives: Other: Hydrogen Peroxide and Carbamide Peroxide |
| HP 10% + HP 40% | Active comparator | Hydrogen Peroxide 10% + Hydrogen Peroxide 40% were administered to each patient on this group. HP at Home and HP at office Receives: Other: Hydrogen Peroxide and Hydrogen Peroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in color after the intervention
The color was taken with conventional hade guide VITA by human observation, with the color range from A to D, each color range with 5 classifications. (Ej. A1, A2, A3, A4, A5)
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study startFeb 2014
- Primary completionJan 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tooth StainStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Iberoamericana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leandro Feliz, Universidad Iberoamericana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682329
- Sponsor's protocol ID
- Dental Bleaching Techniques
- Status last verified
- Feb 2016
- First submitted
- 3 Feb 2016
- Last updated
- 18 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Feliz-Matos L, Hernandez LM, Abreu N. Dental Bleaching Techniques; Hydrogen-carbamide Peroxides and Light Sources for Activation, an Update. Mini Review Article. Open Dent J. 2015 Jan 6;8:264-8. doi: 10.2174/1874210601408010264. eCollection 2014.
PubMed 25646134
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Dental Bleaching Techniques, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02682329
- Acronym / sponsor ID
- Dental Bleaching Techniques
- Conditions
- Tooth Stain
- Keywords
- Peroxide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Universidad IberoamericanaUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 15 Feb 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.
To determine the effectiveness of combining different concentrations of hydrogen peroxide and carbamide used during tooth bleaching.
Detailed description
120 patiens over 18 years old.
Design:
Hydrogen peroxide (HP) Carbamide Peroxide (CP)
Group 1: CP 10% + HP 40% Group 2: CP 15% + HP 40% Group 3: CP 20% + HP 40% Group 4: HP 10% + HP 40%
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CP 10% + HP 40% | Active comparator | Other: Hydrogen Peroxide and Carbamide PeroxideCarbamide Peroxide 10% + Hydrogen Peroxide 40% were administered to each patient on this group. CP at home and HP at office |
| CP 15% + HP 40% | Active comparator | Other: Hydrogen Peroxide and Carbamide PeroxideCarbamide Peroxide 15% + Hydrogen Peroxide 40% were administered to each patient on this group.CP at home and HP at office |
| CP 20% + HP 40% | Active comparator | Other: Hydrogen Peroxide and Carbamide PeroxideCarbamide Peroxide 20% + Hydrogen Peroxide 40% were administered to each patient on this group.CP at home and HP at office |
| HP 10% + HP 40% | Active comparator | Other: Hydrogen Peroxide and Hydrogen PeroxideHydrogen Peroxide 10% + Hydrogen Peroxide 40% were administered to each patient on this group. HP at Home and HP at office |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18 - 45 years old
- Student, teacher or administrative personnel at UNIBE.
Key exclusion criteria (5 listed)
- Dental Hypersensitivity
- Periodontal disease
- Active caries lesions
- Allergy to latex
- Orthodontic treatment
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 |
|---|---|---|
| Hydrogen Peroxide and Carbamide PeroxideCarbamide Peroxide + Hydrogen Peroxide were administered to each patient on this group. HP 10% at home and HP 40% at office | Other | CP 10% + HP 40%, CP 15% + HP 40%, CP 20% + HP 40% |
| Hydrogen Peroxide and Hydrogen PeroxideHydrogen Peroxide + Hydrogen Peroxide were administered to each patient on this group. HP at home and HP at office | Other | HP 10% + HP 40% |
Primary outcome
Change in color after the intervention
Time frame: Two weeks
The color was taken with conventional hade guide VITA by human observation, with the color range from A to D, each color range with 5 classifications. (Ej. A1, A2, A3, A4, A5)
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 Feb 2016.
- Results publication: PubMed 25646134Feliz-Matos L, Hernandez LM, Abreu N. Dental Bleaching Techniques; Hydrogen-carbamide Peroxides and Light Sources for Activation, an Update. Mini Review Article. Open Dent J. 2015 Jan 6;8:264-8. doi: 10.2174/1874210601408010264. eCollection 2014.
- Individual participant dataSharing planned: Undecided
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Tooth Discoloration
Active, not recruitingObservational study
Clinical Evaluation of Discoloration Induced by Root Canal Treatment in Vital and Devital Teeth
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydrogen Peroxide and Carbamide Peroxide and Hydrogen Peroxide and Hydrogen Peroxide in people with Tooth Stain, run by Universidad Iberoamericana.
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 2 inclusion and 5 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 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in color after the intervention (time frame: Two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02682329, which also lists 1 linked publication.
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 Feb 2016.