Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05028335
Other study ID # UFPara-0010
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 7, 2020
Est. completion date June 5, 2021

Study information

Verified date August 2021
Source Universidade Federal do Para
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date June 5, 2021
Est. primary completion date April 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 29 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Carbamide Peroxide (PC) 22%) + placebo gel
Application of one drop of Polanight bleaching agent (SDI, SP, Brazil) on each corresponding tooth in a tray that was used for 45 minutes a day, for a period of twenty-one days. After the bleaching treatment, the participants were instructed to wash the trays under running water and dry them. The volunteers were instructed to apply a small amount of placebo gel, without active ingredient, with color, texture and odor similar to 1.5% oxalate gel (Painless, BM4, SC, Brazil) in the spaces related to the vestibular portions of the teeth trays, which were used for 10 minutes.
Carbamide Peroxide (PC) 22%) + Potassium Oxalate gel 1.5%
Application of one drop of Polanight bleaching agent (SDI, SP, Brazil) on each corresponding tooth in a tray that was used for 45 minutes a day, for a period of twenty-one days. After the bleaching treatment, the participants were instructed to wash the trays under running water and dry them with absorbent paper. The volunteers applied a small amount of 1.5% potassium oxalate gel (Painless, BM4, SC, Brazil) in the spaces relative to the vestibular portions of the tray's teeth, which were used for 10 minutes.

Locations

Country Name City State
Brazil Federal University of Pará Belém Pará

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal do Para

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary dentin sensitivity 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. 21 days after the start of the whitening treatment
Primary dental color assessment Color evaluation was performed using the EasyshadeAdvanced spectrophotometer (Vita-Zahnfabrik, GE, Germany), using the CIE L*a*b* system. 21 days and 1 month after the bleaching treatment
See also
  Status Clinical Trial Phase
Completed NCT02753075 - A Study in Dentinal Hypersensitivity (DH) Participants to Assess the Efficacy of an Occluding Dentifrice. N/A
Active, not recruiting NCT06045026 - A Real-World Evidence Study Evaluating Oral Health Related Quality Of Life With Use Of A Stannous Fluoride Anti-Sensitivity Toothpaste For Dentin Hypersensitivity Management N/A
Completed NCT02861664 - Assessment of the Efficacy of an Experimental Occlusion Technology Dentifrice in Dentinal Hypersensitivity N/A
Completed NCT02542943 - Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Dentinal Hypersensitivity N/A
Completed NCT02226562 - Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief From Dentinal Hypersensitivity Phase 2
Completed NCT02919202 - Clinical Trial to Compare the Efficacy of a Fluoride Gel and a Dental Bonding Agent in Treatment of Tooth Sensitivity N/A
Not yet recruiting NCT04485299 - Clinical Assessment of Bifluorid 10 vs Varnish Fluoride on The Exposed Hypersensitive Cervical Dentin in Adult Patient Phase 2/Phase 3
Completed NCT02931734 - Assessment of Different Protocols for Cervical Dentin Hypersensitivity Treatment N/A
Completed NCT02923895 - To Investigate the Efficacy of an Occluding Dentifrice in Dentinal Hypersensitivity (DH) Phase 4
Withdrawn NCT03361774 - A Clinical Method Development Study to Characterise The Efficacy of a Dentifrice For The Relief Of Dentin Hypersensitivity Phase 2
Completed NCT02924350 - The Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity (DH) N/A
Completed NCT05083052 - Propolis in Reducing Dentin Hypersensitivity N/A
Active, not recruiting NCT06150573 - A Study Assessing the Effects of an Experimental Dentifrice in Maintaining Tooth Color Following Tooth Bleaching N/A
Completed NCT02937623 - To Evaluate the Efficacy of an Experimental Dissolvable Strip in Rapidly Relieving Dentinal Hypersensitivity (DH) N/A
Completed NCT02612064 - The Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity N/A
Completed NCT02293044 - A Study to Evaluate the Safety and Efficacy of an Oxalate Strip on Adjacent Teeth With Dentinal Hypersensitivity N/A
Completed NCT02128633 - Effectiveness of a Homecare Dentin Hypersensitivity Gel Phase 2/Phase 3
Completed NCT03310268 - A Clinical Study to Evaluate a Stannous Fluoride Toothpaste for the Relief of Dentinal Hypersensitivity N/A
Completed NCT05750745 - A Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste for the Relief of Dentine Hypersensitivity in a Chinese Population N/A
Completed NCT02752958 - Impact of Long Term Management of Dentine Hypersensitivity (DH) With a Daily Use Anti-sensitivity Toothpaste on the Quality of Life Related to Oral Health N/A