Treatment of Tooth Sensitivity With the Use of Biorepair Toothpaste
Primary Purpose
Dentinal Hypersensitivity
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Single arm clinical study
Sponsored by
About this trial
This is an interventional treatment trial for Dentinal Hypersensitivity focused on measuring Biorepair sensitive toothpaste, Clinical trial, Dentinal Hypersensitivity, Schiff Sensitivity Scale, Zinc-carbonate hydroxyapatite nanocrystals
Eligibility Criteria
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
Sites / Locations
- College of Dentistry Qassim University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Clinical trials with a single arm
Arm Description
: Participants will be treated with desensitizing toothpaste containing zinc-carbonate hydroxyapatite nanocrystals (Zn-CHA) for 8 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04091256
Brief Title
Treatment of Tooth Sensitivity With the Use of Biorepair Toothpaste
Official Title
Evaluate Efficacy of Desensitizing Toothpaste Containing Zinc-carbonate Hydroxyapatite Before and After: A 8 Week Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 18, 2019 (Actual)
Primary Completion Date
July 29, 2019 (Actual)
Study Completion Date
August 26, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qassim University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
= Subject responds to air stimulus but does not request discontinuation of stimulus
= Subject responds to air stimulus and requests discontinuation or moves from stimulus
= Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentinal Hypersensitivity
Keywords
Biorepair sensitive toothpaste, Clinical trial, Dentinal Hypersensitivity, Schiff Sensitivity Scale, Zinc-carbonate hydroxyapatite nanocrystals
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Clinical trials with a single arm: Participants will be treated with desensitizing toothpaste containing zinc-carbonate hydroxyapatite nanocrystals (Zn-CHA) for 8 weeks.
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clinical trials with a single arm
Arm Type
Experimental
Arm Description
: Participants will be treated with desensitizing toothpaste containing zinc-carbonate hydroxyapatite nanocrystals (Zn-CHA) for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Single arm clinical study
Intervention Description
Participants will be treated with desensitizing toothpaste containing zinc-carbonate hydroxyapatite nanocrystals (Zn-CHA) for 8 weeks.
Primary Outcome Measure Information:
Title
Dentine hypersensitivity (DH) evaluation by means of air-blast sensitivity test, using Schiff Sensitivity Scale (SSS) after 4 weeks.
Description
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.
Time Frame
4 Weeks
Secondary Outcome Measure Information:
Title
Dentine hypersensitivity (DH) evaluation by means of air-blast sensitivity test, using Schiff Sensitivity Scale (SSS) after 8 weeks
Description
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.
Time Frame
8 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dhafer Al Asmari, Board
Organizational Affiliation
Qassim University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Muhammad K Khan, PhD
Organizational Affiliation
Qassim University
Official's Role
Principal Investigator
Facility Information:
Facility Name
College of Dentistry Qassim University
City
Buraidah
State/Province
Al Qassim
ZIP/Postal Code
51452
Country
Saudi Arabia
12. IPD Sharing Statement
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Treatment of Tooth Sensitivity With the Use of Biorepair Toothpaste
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