NCT03528356

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 17, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

May 30, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
Last Updated

May 31, 2018

Status Verified

May 1, 2018

Enrollment Period

1 month

First QC Date

May 7, 2018

Last Update Submit

May 29, 2018

Conditions

Tooth Discoloration

Outcome Measures

Primary Outcomes (1)

  • Tooth color

    Will be assessed using a spectrophotometer

    6 months

Secondary Outcomes (1)

  • Food frequency questionnaire

    6 months

Study Arms (2)

Regular diet

PLACEBO COMPARATOR
Behavioral: Regular diet

White diet

EXPERIMENTAL
Behavioral: Regular diet

Interventions

Regular dietBEHAVIORAL

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

Regular dietWhite diet

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults, aged 18 or higher;
  • Central incisors with shade A2 or darker

You may not qualify if:

  • Undergone previous dental bleaching procedures;
  • Under orthodontic treatment;
  • Pregnant or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal Univeristy of Pelotas

Pelotas, Rio Grande do Sul, 96015080, Brazil

RECRUITING

MeSH Terms

Conditions

Tooth Discoloration

Interventions

Diet

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 7, 2018

First Posted

May 17, 2018

Study Start

May 30, 2018

Primary Completion

June 30, 2018

Study Completion

July 30, 2018

Last Updated

May 31, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)