Treatment of Tooth Sensitivity With the Use of Biorepair Toothpaste

Dentinal Hypersensitivity Clinical Trial

Official title:

Evaluate Efficacy of Desensitizing Toothpaste Containing Zinc-carbonate Hydroxyapatite Before and After: A 8 Week Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04091256
• Other study ID #: ST/55/2019
• Status: Completed
• Phase: N/A
• Start date: January 18, 2019
• Est. completion date: August 26, 2019

Study information

• Verified date: September 2019
• Source: Qassim University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 26, 2019
• Est. primary completion date: July 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Dentinal Hypersensitivity
• Hypersensitivity

Intervention

Other:
• Single arm clinical study
Participants will be treated with desensitizing toothpaste containing zinc-carbonate hydroxyapatite nanocrystals (Zn-CHA) for 8 weeks.

Locations

Country	Name	City	State
Saudi Arabia	College of Dentistry Qassim University	Buraidah	Al Qassim

Sponsors (1)

Lead Sponsor	Collaborator
Qassim University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dentine hypersensitivity (DH) evaluation by means of air-blast sensitivity test, using Schiff Sensitivity Scale (SSS) after 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.	4 Weeks
Secondary	Dentine hypersensitivity (DH) evaluation by means of air-blast sensitivity test, using Schiff Sensitivity Scale (SSS) after 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.	8 Weeks