Clinical trial NCT04091256: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dentinal Hypersensitivity
Keywords: Biorepair sensitive toothpaste
Clinical trial
Dentinal Hypersensitivity
Schiff Sensitivity Scale
Zinc-carbonate hydroxyapatite nanocrystals
Lead sponsor: Qassim University
Sponsor class: OTHER
First posted: 2019-09-16
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Dentine hypersensitivity (DH) evaluation by means of air-blast sensitivity test, using Schiff Sensitivity Scale (SSS) after 4 weeks.
timeFrame: 4 Weeks
Secondary outcomes:
measure: Dentine hypersensitivity (DH) evaluation by means of air-blast sensitivity test, using Schiff Sensitivity Scale (SSS) after 8 weeks
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: Buraidah
country: Saudi Arabia
facility: College of Dentistry Qassim University
state: Al Qassim
Study officials:
affiliation: Qassim University
name: Dhafer Al Asmari, Board
role: PRINCIPAL_INVESTIGATOR
affiliation: Qassim University
name: Muhammad K Khan, PhD
role: PRINCIPAL_INVESTIGATOR
References: