NCT03514797

Brief Summary

This parallel, randomized, and controlled clinical trial will assess the effect of a single prior session of in-office dental bleaching on time required to achieve satisfactory tooth color with at-home bleaching. Participants enrolled will randomly allocated to receive or not a single session of dental bleaching with 35% hydrogen peroxide applied for 45 min. Following, all participants will use customized trays filled with 10% carbamide peroxide for 1h per day until obtain satisfactory results. The primary outcome will be the number of days necessary to obtain satisfactory tooth color. Furthermore, tooth sensitivity and color changes measured with spectrophotometer will be assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

April 13, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 2, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

April 19, 2019

Status Verified

April 1, 2019

Enrollment Period

3 months

First QC Date

April 13, 2018

Last Update Submit

April 17, 2019

Conditions

Tooth Discoloration

Keywords

Tooth bleachingHydrogen peroxideCarbamide peroxideTooth Bleaching Agents

Outcome Measures

Primary Outcomes (1)

  • Time to tooth color satisfaction

    Time in days performing at-home bleaching necessary to participant reports that is satisfied with the tooth color obtained

    up to 1 month after beginning the tooth bleaching procedures

Secondary Outcomes (2)

  • Color change

    up to 1 month after beginning the tooth bleaching procedures

  • Tooth sensitivity

    1, 2, 3, and 4 week after beginning the tooth bleaching procedures

Study Arms (2)

Combined technique

EXPERIMENTAL

A single session of in-office tooth bleaching will be performed with 35% hydrogen peroxide for 45 minutes. Following, the teeth will be further bleached with customized trays filled with 10% carbamide peroxide and used for 1h per day.

Drug: Bleaching Agents

At-home bleaching

ACTIVE COMPARATOR

The teeth will be bleached only with customized trays filled with 10% carbamide peroxide and used for 1h per day.

Drug: Bleaching Agents

Interventions

Bleaching AgentsDRUG

In-office tooth bleaching with 35% hydrogen peroxide in a single application of 45 minutes.

Combined technique

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Good general and oral health;
  • Upper canines darker than the tab 2.5M2 at VITA Bleachedguide 3D-MASTER® (Vita-Zahnfabrik, Bad Sackingen, Germany) scale.

You may not qualify if:

  • Presence of non-treated caries or periodontal disease;
  • Prior tooth hypersensitivity;
  • Presence of gingival recession;
  • Teeth with cracked enamel or any hypoplasia;
  • Patients using oral removable or fixed orthodontic appliances;
  • Patients were pregnant or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Sergipe

Aracaju, Sergipe, 49060100, Brazil

Location

Related Publications (2)

  • Rezende M, Ferri L, Kossatz S, Loguercio AD, Reis A. Combined Bleaching Technique Using Low and High Hydrogen Peroxide In-Office Bleaching Gel. Oper Dent. 2016 Jul-Aug;41(4):388-96. doi: 10.2341/15-266-C. Epub 2016 Feb 26.

    PMID: 26919081BACKGROUND

  • Cardoso PC, Reis A, Loguercio A, Vieira LC, Baratieri LN. Clinical effectiveness and tooth sensitivity associated with different bleaching times for a 10 percent carbamide peroxide gel. J Am Dent Assoc. 2010 Oct;141(10):1213-20. doi: 10.14219/jada.archive.2010.0048.

    PMID: 20884923BACKGROUND

MeSH Terms

Conditions

Tooth Discoloration

Interventions

Bleaching Agents

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

OxidantsSpecialty Uses of ChemicalsChemical Actions and Uses

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 13, 2018

First Posted

May 2, 2018

Study Start

April 13, 2018

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

April 19, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)