Impact of Dietary Counseling on Efficacy of Tooth Bleaching

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.

Study Overview

• Status: Unknown
• Conditions: Tooth Discoloration
• Intervention / Treatment: Behavioral: Regular diet

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Pelotas, RS, Brazil, 96015080
      • Recruiting
      • Federal Univeristy of Pelotas
      • Contact: Maximiliano S Cenci, PhD; Phone Number: 555332256741; Email: cencims@gmail.com
      • Contact: Marina C Franco, DDS; Phone Number: 5553997072679; Email: mxchrist@live.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Regular diet	Behavioral: Regular diet; Patients will not receive any information regarding their usual diet. They will simply perform home dental bleaching.
Experimental: White diet	Behavioral: Regular diet; Patients will not receive any information regarding their usual diet. They will simply perform home dental bleaching.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tooth color	Will be assessed using a spectrophotometer	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Federal University of Pelotas

Study record dates

Study Major Dates

• Study Start (Anticipated): May 30, 2018
• Primary Completion (Anticipated): June 30, 2018
• Study Completion (Anticipated): July 30, 2018

Study Registration Dates

• First Submitted: May 7, 2018
• First Submitted That Met QC Criteria: May 7, 2018
• First Posted (Actual): May 17, 2018

Study Record Updates

• Last Update Posted (Actual): May 31, 2018
• Last Update Submitted That Met QC Criteria: May 29, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Discoloration
• Other Study ID Numbers: PPGO026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No