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Treatment of Tooth Sensitivity With the Use of Biorepair Toothpaste

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ClinicalTrials.gov Identifier: NCT04091256
Recruitment Status : Completed
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Muhammad Khalil Khan, 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

Condition or disease Intervention/treatment Phase
Dentinal Hypersensitivity Other: Single arm clinical study Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Evaluate Efficacy of Desensitizing Toothpaste Containing Zinc-carbonate Hydroxyapatite Before and After: A 8 Week Clinical Study
Actual Study Start Date : January 18, 2019
Actual Primary Completion Date : July 29, 2019
Actual Study Completion Date : August 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

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




Primary Outcome Measures :
  1. Dentine hypersensitivity (DH) evaluation by means of air-blast sensitivity test, using Schiff Sensitivity Scale (SSS) after 4 weeks. [ Time Frame: 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 :
  1. Dentine hypersensitivity (DH) evaluation by means of air-blast sensitivity test, using Schiff Sensitivity Scale (SSS) after 8 weeks [ Time Frame: 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.



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091256


Locations
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Saudi Arabia
College of Dentistry Qassim University
Buraidah, Al Qassim, Saudi Arabia, 51452
Sponsors and Collaborators
Qassim University
Investigators
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Principal Investigator: Dhafer Al Asmari, Board Qassim University
Principal Investigator: Muhammad K Khan, PhD Qassim University

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Responsible Party: Muhammad Khalil Khan, Associate Professor, Qassim University
ClinicalTrials.gov Identifier: NCT04091256     History of Changes
Other Study ID Numbers: ST/55/2019
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Muhammad Khalil Khan, Qassim University:
Biorepair sensitive toothpaste
Clinical trial
Dentinal Hypersensitivity
Schiff Sensitivity Scale
Zinc-carbonate hydroxyapatite nanocrystals
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases
Zinc
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs