Impact of Dietary Counseling on Efficacy of Tooth Bleaching

Tooth Discoloration Clinical Trial

Official title:

The Impact of Dietary Counseling on the Efficacy of Tooth Bleaching: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03528356
• Other study ID #: PPGO026
• Status: Recruiting
• Phase: N/A
• Start date: May 30, 2018
• Est. completion date: July 30, 2018

Study information

• Verified date: May 2018
• Source: Federal University of Pelotas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Adults, aged 18 or higher;

• Central incisors with shade A2 or darker

Exclusion Criteria:

• Undergone previous dental bleaching procedures;

• Under orthodontic treatment;

• Pregnant or lactating women.

Related Conditions & MeSH terms

• Tooth Discoloration

Intervention

Behavioral:
• Regular diet
Patients will not receive any information regarding their usual diet. They will simply perform home dental bleaching.

Locations

Country	Name	City	State
Brazil	Federal Univeristy of Pelotas	Pelotas	RS

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Pelotas

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tooth color	Will be assessed using a spectrophotometer	6 months
Secondary	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).	6 months