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Effects of Desensitizing Dentifrices on the Reduction of Pain Sensitivity Caused by In-office Dental Whitening

U

University of Campinas, Brazil

Status and phase

Completed
Phase 4

Conditions

Tooth Whitening
Sensitivity

Treatments

Drug: Hydrogen peroxide
Procedure: Gingival protection barrier
Procedure: Relative isolation
Procedure: Application of desensitizing gel
Procedure: Selection and preparation of the volunteers
Procedure: Used a dentifrice
Procedure: Evaluation of the tooth color

Study type

Interventional

Funder types

Other

Identifiers

NCT03019224
104/2015

Details and patient eligibility

About

Introduction: The pain sensitivity associated with whitening is the main problem reported by patients during dental whitening, and the use of desensitizing dentifrices is an alternative for the treatment of sensitivity.

Objective: To evaluate clinically the influence of desensitizing dentifrices applied through a plastic tray, reducing the pain sensitivity and color variation caused by the technique of in-office dental whitening, through a controlled double-blind clinical study.

Methods: A longitudinal prospective study was conducted with 48 individuals, 18 years and 30 years of age, without gender distinction, who underwent in-office dental whitening using 35% hydrogen peroxide (Whiteness HP, FGM, Joinville , SC, Brazil) in three clinical sessions with a one-week interval between them. The volunteers used in the night for each bleaching session a plastic tray for 4 hours containing one of the dentifrices related to the experimental groups: Group 1 (Control) - Sucralose (S) (Biotype - Manipulation pharmacy); Group 2 (Active control) - Sodium fluoride (FS) with 1450ppm of fluorine (Close up triple, Unilever); Group 3 - Arginine, calcium carbonate (ACC) and sodium monofluorophosphate with 1450 ppm fluorine (Colgate sensitive pro-relief, Colgate-Palmolive); Group 4 - 5% potassium nitrate (NP) and sodium fluoride with 1450 ppm fluorine (Sensodyne pro-enamel, GlaxoSmithKline). The evaluation of the sensitivity associated with the times of use of the plastic tray in the first session (S1: sensitivity before the tray, S2: sensitivity after the tray), in the second session (S3: sensitivity before the tray, S4: in the third session (S5: sensitivity before the tray, S6: sensitivity after the tray) used the analog numerical scale with scores from 0 to 10 and for the color evaluation the spectrophotometer (Easyshade, Vident, Brea, CA, Obtaining the data that were used in the CIELab system. The data were submitted to the multivariate analysis of variance (MANOVA) with repeated measurements and Lambda Wilks test with a 5% probability level to differentiate the groups. In addition, the factorial variance analysis (ANOVA) in one criterion was applied. Values of p <0.05 were considered statistically significant.

Enrollment

4 patients

Sex

All

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • age of 18 years or older
  • good oral and general health
  • hygid anterior tooth with color shade higher than A2 on the Vita Classic scale (VITA Zahnfabrink, Bad Säckingen, Germany).

Exclusion criteria

  • smoking, pregnancy or breastfeeding
  • previous dental whitening
  • para-functional habits
  • dentin sensitivity
  • anterior tooth with restorations and carious lesions
  • non-vital discoloration
  • unsatisfactory restorations

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Double Blind

4 participants in 4 patient groups, including a placebo group

Group 1
Placebo Comparator group
Description:
The use of desensitizing dentifrice \[Sucralose (S) Control dentifrice)\] in plastic tray.
Treatment:
Drug: Hydrogen peroxide
Procedure: Gingival protection barrier
Procedure: Relative isolation
Procedure: Application of desensitizing gel
Procedure: Used a dentifrice
Procedure: Evaluation of the tooth color
Procedure: Selection and preparation of the volunteers
Group 2
Experimental group
Description:
The use of desensitizing dentifrice \[Sodium fluoride (FS) with 1450ppm of fluorine (Close up triple, Unilever)\] in plastic tray.
Treatment:
Drug: Hydrogen peroxide
Procedure: Gingival protection barrier
Procedure: Relative isolation
Procedure: Application of desensitizing gel
Procedure: Used a dentifrice
Procedure: Evaluation of the tooth color
Procedure: Selection and preparation of the volunteers
Group 3
Experimental group
Description:
The use of desensitizing dentifrice \[Arginine, calcium carbonate (ACC) and sodium monofluorophosphate with 1450 ppm fluorine (Colgate sensitive pro-relief, Colgate-Palmolive)\] in plastic tray.
Treatment:
Drug: Hydrogen peroxide
Procedure: Gingival protection barrier
Procedure: Relative isolation
Procedure: Application of desensitizing gel
Procedure: Used a dentifrice
Procedure: Evaluation of the tooth color
Procedure: Selection and preparation of the volunteers
Group 4
Experimental group
Description:
The use of desensitizing dentifrice \[Sodium fluoride based dentifrice with 1450 ppm of fluorine associated with 5% potassium nitrate\] in plastic tray.
Treatment:
Drug: Hydrogen peroxide
Procedure: Gingival protection barrier
Procedure: Relative isolation
Procedure: Application of desensitizing gel
Procedure: Used a dentifrice
Procedure: Evaluation of the tooth color
Procedure: Selection and preparation of the volunteers

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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