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

Phase 4

Completed

• Conditions: Sensitivity; Tooth Whitening
• Interventions: Procedure: Selection and preparation of the volunteers; Procedure: Evaluation of the tooth color; Procedure: Relative isolation; Procedure: Gingival protection barrier; Procedure: Application of desensitizing gel; Drug: Hydrogen peroxide; Procedure: Used a dentifrice

• Registration Number: NCT03019224
• Lead Sponsor: University of Campinas, Brazil

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-01
• Study Start: 2016-01
• Primary Completion: 2016-04
• Study Completion: 2016-08
• Study First Submitted: 2016-12-19
• Study First Submitted QC: 2017-01-11
• Last Update Submitted: 2017-01-11
• Study First Posted: 2017-01-12
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Group 2	Used a dentifrice	The use of desensitizing dentifrice \[Sodium fluoride (FS) with 1450ppm of fluorine (Close up triple, Unilever)\] in plastic tray.
Group 1	Relative isolation	The use of desensitizing dentifrice \[Sucralose (S) Control dentifrice)\] in plastic tray.
Group 1	Gingival protection barrier	The use of desensitizing dentifrice \[Sucralose (S) Control dentifrice)\] in plastic tray.
Group 2	Application of desensitizing gel	The use of desensitizing dentifrice \[Sodium fluoride (FS) with 1450ppm of fluorine (Close up triple, Unilever)\] in plastic tray.
Group 3	Evaluation of the tooth color	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.
Group 3	Gingival protection barrier	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.
Group 4	Selection and preparation of the volunteers	The use of desensitizing dentifrice \[Sodium fluoride based dentifrice with 1450 ppm of fluorine associated with 5% potassium nitrate\] in plastic tray.
Group 2	Evaluation of the tooth color	The use of desensitizing dentifrice \[Sodium fluoride (FS) with 1450ppm of fluorine (Close up triple, Unilever)\] in plastic tray.
Group 4	Application of desensitizing gel	The use of desensitizing dentifrice \[Sodium fluoride based dentifrice with 1450 ppm of fluorine associated with 5% potassium nitrate\] in plastic tray.
Group 1	Selection and preparation of the volunteers	The use of desensitizing dentifrice \[Sucralose (S) Control dentifrice)\] in plastic tray.
Group 3	Used a dentifrice	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.
Group 1	Evaluation of the tooth color	The use of desensitizing dentifrice \[Sucralose (S) Control dentifrice)\] in plastic tray.
Group 1	Used a dentifrice	The use of desensitizing dentifrice \[Sucralose (S) Control dentifrice)\] in plastic tray.
Group 2	Selection and preparation of the volunteers	The use of desensitizing dentifrice \[Sodium fluoride (FS) with 1450ppm of fluorine (Close up triple, Unilever)\] in plastic tray.
Group 2	Relative isolation	The use of desensitizing dentifrice \[Sodium fluoride (FS) with 1450ppm of fluorine (Close up triple, Unilever)\] in plastic tray.
Group 1	Application of desensitizing gel	The use of desensitizing dentifrice \[Sucralose (S) Control dentifrice)\] in plastic tray.
Group 3	Selection and preparation of the volunteers	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.
Group 4	Evaluation of the tooth color	The use of desensitizing dentifrice \[Sodium fluoride based dentifrice with 1450 ppm of fluorine associated with 5% potassium nitrate\] in plastic tray.
Group 4	Gingival protection barrier	The use of desensitizing dentifrice \[Sodium fluoride based dentifrice with 1450 ppm of fluorine associated with 5% potassium nitrate\] in plastic tray.
Group 2	Gingival protection barrier	The use of desensitizing dentifrice \[Sodium fluoride (FS) with 1450ppm of fluorine (Close up triple, Unilever)\] in plastic tray.
Group 4	Relative isolation	The use of desensitizing dentifrice \[Sodium fluoride based dentifrice with 1450 ppm of fluorine associated with 5% potassium nitrate\] in plastic tray.
Group 4	Used a dentifrice	The use of desensitizing dentifrice \[Sodium fluoride based dentifrice with 1450 ppm of fluorine associated with 5% potassium nitrate\] in plastic tray.
Group 3	Relative isolation	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.
Group 3	Application of desensitizing gel	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.
Group 1	Hydrogen peroxide	The use of desensitizing dentifrice \[Sucralose (S) Control dentifrice)\] in plastic tray.
Group 2	Hydrogen peroxide	The use of desensitizing dentifrice \[Sodium fluoride (FS) with 1450ppm of fluorine (Close up triple, Unilever)\] in plastic tray.
Group 3	Hydrogen peroxide	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.
Group 4	Hydrogen peroxide	The use of desensitizing dentifrice \[Sodium fluoride based dentifrice with 1450 ppm of fluorine associated with 5% potassium nitrate\] in plastic tray.

Primary Outcome Measures

Name	Time	Method
The analysis of the reduction of sensitivity using the toothpaste during whitening.	Through study completion up to 4 weeks placement of the tray.	For sensitivity analysis was used the numerical analogue scale with scores ranging from 0 to 10.
The evaluation of the tooth color using the toothpaste during whitening.	Through study completion up to 4 weeks placement of the tray.	For evaluation of the tooth color was performed by using a spectrophotometer. (Easyshade, Vident, Brea, CA, USA). The color was determined by EasyShade device.