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Clinical Trials/NCT05028335
NCT05028335CompletedNot Applicable

Effect of 1.5% Potassium Oxalate on the Control of Tooth Sensitivity and Color Change After Home Bleaching: a Randomized, Placebo-controlled Clinical Study

Universidade Federal do Para2 sites in 1 country50 target enrollmentStarted: December 7, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
2
Primary Endpoint
dental color assessment

Study Overview

Brief Summary

This double-blind randomized clinical trial evaluated the effect of 1.5% potassium oxalate on pain sensitivity control and color change after home tooth whitening. It also evaluated the influence of potassium oxalate on health-related quality of life (HRQOL) and on the degree of patient satisfaction after bleaching treatment.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 29 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • individuals aged 18 to 29 years of both sexes with chroma greater than A2 in the upper incisors and canines, in the Vita Classical color scale;
  • absence of active caries lesions
  • patients who had never undergone bleaching therapy;
  • good oral hygiene and no hypersensitivity to tactile and evaporative stimuli through the Visual Analog Pain Scale;

Exclusion Criteria

  • patients undergoing fixed orthodontic treatment;
  • patients with darkened non-vital teeth and/or with extensive restorations in molars;
  • presence of cracks or fractures;
  • patients allergic to the product, with the presence of gastroesophageal disorders and with dentinal exposure in anterior and/or posterior teeth.

Outcomes

Primary Outcomes

dental color assessment

Time Frame: 21 days and 1 month after the bleaching treatment

Color evaluation was performed using the EasyshadeAdvanced spectrophotometer (Vita-Zahnfabrik, GE, Germany), using the CIE L\*a\*b\* system.

dentin sensitivity

Time Frame: 21 days after the start of the whitening treatment

evaluation of dentinal sensitivity during treatment through a daily questionnaire, using a visual analogue scale with values from 0 to 10, with higher values indicating a worse level of pain.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Cecy Martins Silva

clinical professor

Universidade Federal do Para

Study Sites (2)

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