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Impact of Dietary Counseling on Efficacy of Tooth Bleaching

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03528356
Recruitment Status : Unknown
Verified May 2018 by Maximiliano Sergio Cenci, Federal University of Pelotas.
Recruitment status was:  Recruiting
First Posted : May 17, 2018
Last Update Posted : May 31, 2018
Information provided by (Responsible Party):
Maximiliano Sergio Cenci, Federal University of Pelotas

Brief 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.

Condition or disease Intervention/treatment Phase
Tooth Discoloration Behavioral: Regular diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Impact of Dietary Counseling on the Efficacy of Tooth Bleaching: a Randomized Controlled Trial
Estimated Study Start Date : May 30, 2018
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : July 30, 2018

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.

Primary Outcome Measures :
  1. Tooth color [ Time Frame: 6 months ]
    Will be assessed using a spectrophotometer

Secondary Outcome Measures :
  1. Food frequency questionnaire [ Time Frame: 6 months ]
    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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03528356

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Federal Univeristy of Pelotas Recruiting
Pelotas, RS, Brazil, 96015080
Contact: Maximiliano S Cenci, PhD    555332256741   
Contact: Marina C Franco, DDS    5553997072679   
Sponsors and Collaborators
Federal University of Pelotas
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Responsible Party: Maximiliano Sergio Cenci, Professor, Federal University of Pelotas Identifier: NCT03528356    
Other Study ID Numbers: PPGO026
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tooth Discoloration
Tooth Diseases
Stomatognathic Diseases