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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05750745
Other study ID # 300026
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 8, 2023
Est. completion date September 19, 2023

Study information

Verified date October 2023
Source HALEON
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of the 0.454 percentage (%) weight/weight (w/w) stannous fluoride (SnF2) toothpastes for the relief of dentine hypersensitivity (DH) in China.


Description:

This study will be a single center, randomized, controlled, examiner-blind, 3 treatment arm, parallel group design study, stratified by maximum baseline Schiff sensitivity score (of the 2 selected 'test teeth'), with a treatment period of 12 weeks, to investigate the clinical efficacy of a SnF2 toothpaste for the relief of DH in a Chinese population. The SnF2 test dentifrice will be compared to commercialized negative and positive control toothpastes.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sensodyne Sensitivity & Gum
Sensodyne Sensitivity & Gum toothpaste is containing 0.454% w/w SnF2.
Crest Cavity Protection Fresh Lime
Crest Cavity Protection Fresh Lime is containing 1150 parts per million (ppm) fluoride as Sodium fluoride (NaF).
Sensodyne Repair and Protect
Sensodyne Repair and Protect toothpaste is containing 5.0% w/w calcium sodium phosphosilicate (CSPS).

Locations

Country Name City State
China Department of Preventive Dentistry, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine Shanghai
China Ethics Commitee of Shanghai Ninth People's Hosptial Shanghai

Sponsors (1)

Lead Sponsor Collaborator
HALEON

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in Schiff sensitivity score at Week 12 (Test Dentifrice Versus [vs.] Negative Control) Schiff sensitivity score will be assessed by participant's response to an evaporative (air) stimulus after the stimulation of 2 selected test teeth, response of participant will be scored using Schiff sensitivity scale range of 0-3; 0 equal to (=) Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Higher score indicates worst outcome (more sensitivity). Change from baseline is defined as post dose visit value minus baseline visit value. Baseline is defined as Day 1 (visit 2) value. Baseline and Week 12
Secondary Change from Baseline in tactile threshold (grams [g]) at Week 12 (Test Dentifrice vs. Negative Control) Constant pressure will be administered using Yeaple Probe. At baseline the upper test limit is 20 g and at Week 12, the upper test limit is 80 g. The tactile threshold is the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for 2 selected test teeth will be determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutives 'yes' responses will be recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth. Change from baseline is defined as post dose visit value minus baseline visit value. Baseline is defined as Day 1 (visit 2) value. Baseline and Week 12
Secondary Change from Baseline in VAS (millimeters [mm]) at Week 12 (Test Dentifrice vs. Negative Control) Evaporative air sensitivity will be assessed by examiner as a response to a 1 second application of air from a standard air dental syringe applied to the exposed dentine surface of tooth approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 centimeter (cm). Each participant rates the intensity of their response to the stimulus using a 100 mm VAS, where 0 represented "no discomfort" and 100 represented the "extreme discomfort (worst imaginable)". Higher score indicates worst outcome (more discomfort). Change from baseline is defined as post dose visit value minus baseline visit value. Baseline is defined as Day 1 (visit 2) value. Baseline and Week 12
Secondary Change from Baseline in Schiff sensitivity score at Week 6 (Test Dentifrice vs. Negative Control) Schiff sensitivity score will be assessed by participant's response to an evaporative (air) stimulus after the stimulation of 2 selected test teeth, response of participant will be scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Higher score indicates worst outcome (more sensitivity). Change from baseline is defined as post dose visit value minus baseline visit value. Baseline is defined as Day 1 (visit 2) value. Baseline and Week 6
Secondary Change from Baseline in tactile threshold (g) at Week 6 (Test Dentifrice vs. Negative Control) Constant pressure will be administered using Yeaple Probe. At baseline the upper test limit is 20 g and at Week 6, the upper test limit is 80 g. The tactile threshold is the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for 2 selected test teeth will be determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutives 'yes' responses will be recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth. Change from baseline is defined as post dose visit value minus baseline visit value. Baseline is defined as Day 1 (visit 2) value. Baseline and Week 6
Secondary Change from Baseline in VAS (mm) at Week 6 (Test Dentifrice vs. Negative Control) Evaporative air sensitivity will be assessed by examiner as a response to a 1 second application of air from a standard air dental syringe applied to the exposed dentine surface of tooth approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 centimeter (cm). Each participant rates the intensity of their response to the stimulus using a 100 mm VAS, where 0 represented "no discomfort" and 100 represented the "extreme discomfort (worst imaginable)". Higher score indicates worst outcome (more discomfort). Change from baseline is defined as post dose visit value minus baseline visit value. Baseline is defined as Day 1 (visit 2) value. Baseline and Week 6
Secondary Change from Baseline in Schiff sensitivity score at Week 6 (Positive control vs. Negative Control) Schiff sensitivity score will be assessed by participant's response to an evaporative (air) stimulus after the stimulation of 2 selected test teeth, response of participant will be scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Higher score indicates worst outcome (more sensitivity). Change from baseline is defined as post dose visit value minus baseline visit value. Baseline is defined as Day 1 (visit 2) value. Baseline and Week 6
Secondary Change from Baseline in tactile threshold (g) at Week 6 (Positive control vs. Negative Control) Constant pressure will be administered using Yeaple Probe. At baseline the upper test limit is 20 g and at Week 6, the upper test limit is 80 g. The tactile threshold is the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for 2 selected test teeth will be determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutives 'yes' responses will be recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth. Change from baseline is defined as post dose visit value minus baseline visit value. Baseline is defined as Day 1 (visit 2) value. Baseline and Week 6
Secondary Change from Baseline in VAS (mm) at Week 6 (Positive control vs. Negative Control) Evaporative air sensitivity will be assessed by examiner as a response to a 1 second application of air from a standard air dental syringe applied to the exposed dentine surface of tooth approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 centimeter (cm). Each participant rates the intensity of their response to the stimulus using a 100 mm VAS, where 0 represented "no discomfort" and 100 represented the "extreme discomfort (worst imaginable)". Higher score indicates worst outcome (more discomfort). Change from baseline is defined as post dose visit value minus baseline visit value. Baseline is defined as Day 1 (visit 2) value. Baseline and Week 6
Secondary Change from Baseline in Schiff sensitivity score at Week 12 (Positive control vs. Negative Control) Schiff sensitivity score will be assessed by participant's response to an evaporative (air) stimulus after the stimulation of 2 selected test teeth, response of participant will be scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Higher score indicates worst outcome (more sensitivity). Change from baseline is defined as post dose visit value minus baseline visit value. Baseline is defined as Day 1 (visit 2) value. Baseline and Week 12
Secondary Change from Baseline in tactile threshold (g) at Week 12 (Positive control vs. Negative Control) Constant pressure will be administered using Yeaple Probe. At baseline the upper test limit is 20 g and at Week 12, the upper test limit is 80 g. The tactile threshold is the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for 2 selected test teeth will be determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutives 'yes' responses will be recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth. Change from baseline is defined as post dose visit value minus baseline visit value. Baseline is defined as Day 1 (visit 2) value. Baseline and Week 12
Secondary Change from Baseline in VAS (mm) at Week 12 (Positive control vs. Negative Control) Evaporative air sensitivity will be assessed by examiner as a response to a 1 second application of air from a standard air dental syringe applied to the exposed dentine surface of tooth approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 centimeter (cm). Each participant rates the intensity of their response to the stimulus using a 100 mm VAS, where 0 represented "no discomfort" and 100 represented the "extreme discomfort (worst imaginable)". Higher score indicates worst outcome (more discomfort). Change from baseline is defined as post dose visit value minus baseline visit value. Baseline is defined as Day 1 (visit 2) value. Baseline and Week 12
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