Back to resultsImpact of Dietary Counseling on Efficacy of Tooth Bleaching
Primary Purpose
Tooth Discoloration
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Regular diet
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Discoloration
Eligibility Criteria
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.
Sites / Locations
- Federal Univeristy of PelotasRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Regular diet
White diet
Arm Description
Outcomes
Primary Outcome Measures
Tooth color
Will be assessed using a spectrophotometer
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT03528356
First Posted
May 7, 2018
Last Updated
May 29, 2018
Sponsor
Federal University of Pelotas
1. Study Identification
Unique Protocol Identification Number
NCT03528356
Brief Title
Impact of Dietary Counseling on Efficacy of Tooth Bleaching
Official Title
The Impact of Dietary Counseling on the Efficacy of Tooth Bleaching: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 30, 2018 (Anticipated)
Primary Completion Date
June 30, 2018 (Anticipated)
Study Completion Date
July 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Pelotas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Discoloration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Regular diet
Arm Type
Placebo Comparator
Arm Title
White diet
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Regular diet
Intervention Description
Patients will not receive any information regarding their usual diet. They will simply perform home dental bleaching.
Primary Outcome Measure Information:
Title
Tooth color
Description
Will be assessed using a spectrophotometer
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Food frequency questionnaire
Description
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).
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Federal Univeristy of Pelotas
City
Pelotas
State/Province
RS
ZIP/Postal Code
96015080
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maximiliano S Cenci, PhD
Phone
555332256741
Email
cencims@gmail.com
First Name & Middle Initial & Last Name & Degree
Marina C Franco, DDS
Phone
5553997072679
Email
mxchrist@live.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Dietary Counseling on Efficacy of Tooth Bleaching
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