Tooth DiscolorationNCT03528356
Impact of Dietary Counseling on Efficacy of Tooth Bleaching
A study testing Regular diet in people with Tooth Discoloration, run by Federal University of Pelotas at 1 site in Brazil.
Trial summary
The aim of this study will be to evaluate if subjects submitted to a white diet counseling during home dental bleaching will present better results than subjects that maintained their usual diets. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Discoloration
- What is being tested?
- Regular diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 30 May 2018to 30 Jul 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults, aged 18 or higher;
- Central incisors with shade A2 or darker
Who cannot join
- Undergone previous dental bleaching procedures;
- Under orthodontic treatment;
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal Univeristy of Pelotas
Pelotas, Rio Grande do Sul, 96015080
Maximiliano S Cenci, PhD, 555332256741, cencims@gmail.com
Marina C Franco, DDS, 5553997072679, mxchrist@live.com
About this study
Official title: The Impact of Dietary Counseling on the Efficacy of Tooth Bleaching: a Randomized Controlled Trial
The aim of this study will be to evaluate if subjects submitted to a white diet counseling during home dental bleaching will present better results than subjects that maintained their usual diets. Forty patients will be divided into two groups and randomly allocated to each group: usual diet (control) or white diet, avoiding dye-containing food and beverages. patients will be assessed through a food frequency questionnaire and color measurement using a spectrophotometer at baseline and six months after bleaching.
- Conditions
- Tooth Discoloration
- Being tested
- Regular diet
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular dietBehavioural
Patients will not receive any information regarding their usual diet. They will simply perform home dental bleaching.
| Study group | Role | What they receive |
|---|---|---|
| Regular diet | Placebo comparator | Not described Receives: Behavioral: Regular diet |
| White diet | Experimental | Not described Receives: Behavioral: Regular diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth color
Will be assessed using a spectrophotometer
Measured: 6 months
Secondary outcomes (1)
Food frequency questionnaire
Patients will respond to a 30 item questionnaire regarding their daily diet. A Food Frequency Questionnaire (FFQ) was constructed to evaluate the consumption of chromogenic food and beverage of patients in the last year. A list of 54 foods and beverages that, according to the literature, have the potential to cause some kind of extrinsic pigmentation, was elaborated. In each food of beverage, the individual will be asked if he consumed in the last year and if the answer is yes, the consumption frequency (0 to 10 times) per unit of time (day, week, month or year). In addition, each individual will answer regarding the amount relative to the mean portion, half of the mean portion, or twice of the mean portion. The size of the mean portions will be considered by calculating the mean of each food consumed. The home measure for the mean portion will be based on the Table of Evaluation of Food Consumption in Home Measures (Pinheiro et al. 2000).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start30 May 2018 (estimated)
- Primary completion30 Jun 2018 (estimated)
- Study completion30 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth DiscolorationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Pelotas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maximiliano Sergio Cenci, Federal University of Pelotas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528356
- Sponsor's protocol ID
- PPGO026
- Status last verified
- May 2018
- First submitted
- 7 May 2018
- Last updated
- 31 May 2018
- Results posted
- 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 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Dietary Counseling on the Efficacy of Tooth Bleaching: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03528356
- Acronym / sponsor ID
- PPGO026
- Conditions
- Tooth Discoloration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Federal University of PelotasUniversity, hospital or other
- Study start
- 30 May 2018 (estimated)
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 30 Jul 2018 (estimated)
- First posted
- 17 May 2018 (actual)
- 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.
The aim of this study will be to evaluate if subjects submitted to a white diet counseling during home dental bleaching will present better results than subjects that maintained their usual diets. Forty patients will be divided into two groups and randomly allocated to each group: usual diet (control) or white diet, avoiding dye-containing food and beverages. patients will be assessed through a food frequency questionnaire and color measurement using a spectrophotometer at baseline and six months after bleaching.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular diet | Placebo comparator | Behavioral: Regular diet |
| White diet | Experimental | Behavioral: Regular diet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults, aged 18 or higher;
- Central incisors with shade A2 or darker
Key exclusion criteria (3 listed)
- Undergone previous dental bleaching procedures;
- Under orthodontic treatment;
- Pregnant or lactating women.
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 |
|---|---|---|
| Regular dietPatients will not receive any information regarding their usual diet. They will simply perform home dental bleaching. | Behavioural | Regular diet, White diet |
Primary outcome
Tooth color
Time frame: 6 months
Will be assessed using a spectrophotometer
1 secondary outcome
Food frequency questionnaire
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2018.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular diet in people with Tooth Discoloration, run by Federal University of Pelotas at 1 site in Brazil.
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 3 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: status not confirmed, as of the sponsor's last update on 31 May 2018. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tooth color (time frame: 6 months). 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 31 May 2018.