NCT05635253

Brief Summary

This trial evaluated the influence of polishing on enamel color change after in-office bleaching treatment. It also evaluated the influence of polishing on tooth morphology and sensitivity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2022

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 2, 2022

Completed
Last Updated

December 2, 2022

Status Verified

November 1, 2022

Enrollment Period

8 months

First QC Date

November 13, 2022

Last Update Submit

November 29, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Influence of polishing on color after tooth whitening

    Color evaluation was performed with the EasyshadeAdvanced spectrophotometer (Vita-Zahnfabrik, GE, Germany)

    14 days

Secondary Outcomes (2)

  • Surface morphology of whitening enamel with and without polishing

    14 days

  • Influence of polishing on sensitivity after tooth whitening

    14 days

Study Arms (2)

GROUP GSEM

OTHER

In-office whitening treatment with 35% Hydrogen Peroxide

Other: Hydrogen Peroxide 35%

GROUP GP

EXPERIMENTAL

In-office whitening treatment with 35% Hydrogen Peroxide + Polishing of whitened teeth

Other: Hydrogen Peroxide 35% + Polishing whitened teeth

Interventions

Group that received only bleaching treatment. Soft tissue protection was performed with a Top Dam light-curing gingival barrier (FGM, Santa Catarina, SC, Brazil). Application of whitening gel (Whitness HP 35%/FGM) on the buccal surface from premolar to premolar in the upper and lower arches. Three 45-minute sessions were held with an interval of seven days between them.

GROUP GSEM

Group that received only bleaching treatment followed by polishing. Soft tissue protection was performed with a Top Dam light-curing gingival barrier (FGM, Santa Catarina, SC, Brazil). Application of whitening gel (Whitness HP 35%/FGM) on the buccal surface from premolar to premolar in the upper and lower arches. Three 45-minute sessions were held with an interval of seven days between them. After bleaching, the vestibular surfaces were polished for 20s on each bleached tooth, with polishing paste and felt disc (Diamond Flex, FGM, Santa Catarina, SC, Brazil) in low rotation.

GROUP GP

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals aged 18 to 30 years old of both sexes;
  • With good oral hygiene;
  • With no sensitivity to tactile and evaporative stimuli;
  • Who have not undergone previous bleaching treatment, and with no caries lesions.

You may not qualify if:

  • patients undergoing fixed orthodontic treatment;
  • patients allergic to the bleaching product;
  • drug users or pregnant women;
  • patients with carious lesions, defective restorations and/or periodontal disease, patients with systemic diseases, pulpitis or patients using analgesics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cecy Martins Silva

Belém, Pará, 66075-110, Brazil

Location

MeSH Terms

Conditions

Tooth DiscolorationDentin Sensitivity

Interventions

Hydrogen Peroxide

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

PeroxidesOxidesAnionsIonsElectrolytesInorganic ChemicalsReactive Oxygen SpeciesFree RadicalsOxygen CompoundsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

November 13, 2022

First Posted

December 2, 2022

Study Start

January 10, 2022

Primary Completion

August 26, 2022

Study Completion

September 12, 2022

Last Updated

December 2, 2022

Record last verified: 2022-11

Locations