Treatment of Tooth Sensitivity With the Use of Biorepair Toothpaste

Not Applicable

Completed

• Conditions: Dentinal Hypersensitivity
• Interventions: Other: Single arm clinical study

• Registration Number: NCT04091256
• Lead Sponsor: Qassim University

Brief Summary

The purpose of this clinical study is to evaluate the effect of desensitizing toothpaste containing zinc-carbonate hydroxyapatite nanocrystals in reducing or controlling DH after 8 weeks of treatment

Detailed Description

This clinical study design is an 8-week single center, before and after use of desensitize dentifrice. This study will conducted in the College of Dentistry Qassim University. 72 patients surfing from DH, include in the study fulfill the inclusion criteria. All subjects 20 to 70 years of age in good health, and must have 2 teeth with DH, will be included in this study. Screening will be performed for the selection of patients, which fulfill the inclusion criteria. Baseline data will be recorded and Sensitivity was assessed by air-blast sensitivity, using Schiff Sensitivity Scale (SSS).

Sensitivity was assessed by air-blast sensitivity, using Schiff Sensitivity Scale (SSS) described as follows.

0 = Subject does not respond to air stimulus

1. = Subject responds to air stimulus but does not request discontinuation of stimulus

2. = Subject responds to air stimulus and requests discontinuation or moves from stimulus

3. = Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus

Study Timeline

• Study Start: 2019-01-18
• Study First Submitted: 2019-07-26
• Primary Completion: 2019-07-29
• Study Completion: 2019-08-26
• Status Verified: 2019-09
• Study First Submitted QC: 2019-09-13
• Last Update Submitted: 2019-09-13
• Study First Posted: 2019-09-16
• Last Update Posted: 2019-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• All male and female subjects 20 to 70 years of age
• All subjects in good health
• All subjects must have 2 teeth with DH, only incisors, canine and premolars were included with the exposed cervical dentin (facial surfaces).

All participants of the study having Schiff Sensitivity Scale score of 2 & 3

Exclusion Criteria

• Subjects with deep carious teeth, defective restorations
• Any pathological lesion
• Periodontal disease, mobile teeth, cracked enamel, orthodontic appliances,
• Periodontal pockets >4mm
• Subjects using pain control medicines, sensitive toothpaste
• Pregnant or lactating women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clinical trials with a single arm	Single arm clinical study	: Participants will be treated with desensitizing toothpaste containing zinc-carbonate hydroxyapatite nanocrystals (Zn-CHA) for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Dentine hypersensitivity (DH) evaluation by means of air-blast sensitivity test, using Schiff Sensitivity Scale (SSS) after 4 weeks.	4 Weeks	This will be assessed using Schiff Sensitivity Scale (SSS) score difference from the baseline, that will be determined immediately before product use and then after 4 weeks of daily brushing with the test sensitive toothpaste. Tooth sensitivity score was assessed by air-blast sensitivity, using Schiff Sensitivity Scale (SSS) as follows: 0 = Subject does not respond to air stimulus, 1 = Subject responds to air stimulus but does not request discontinuation of stimulus, 2 = Subject responds to air stimulus and requests discontinuation or moves from stimulus, 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests.

Secondary Outcome Measures

Name	Time	Method
Dentine hypersensitivity (DH) evaluation by means of air-blast sensitivity test, using Schiff Sensitivity Scale (SSS) after 8 weeks	8 Weeks	This will be assessed using Schiff Sensitivity Scale (SSS) score difference from the baseline, that will be determined immediately before product use and then after 8 weeks of daily brushing with the test sensitive toothpaste. Tooth sensitivity score was assessed by air-blast sensitivity, using Schiff Sensitivity Scale (SSS) as follows: 0 = Subject does not respond to air stimulus, 1 = Subject responds to air stimulus but does not request discontinuation of stimulus, 2 = Subject responds to air stimulus and requests discontinuation or moves from stimulus, 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests.

Trial Locations

Locations (1)

College of Dentistry Qassim University; 🇸🇦 Buraidah, Al Qassim, Saudi Arabia