Treatment of Tooth Sensitivity With the Use of Biorepair Toothpaste

NCT04091256 | Completed

• 1 other identifier: ST/55/2019
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

Dentinal Hypersensitivity

Keywords

Biorepair sensitive toothpaste; Clinical trial; Dentinal Hypersensitivity; Schiff Sensitivity Scale; Zinc-carbonate hydroxyapatite nanocrystals

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Dentine hypersensitivity (DH) evaluation by means of air-blast sensitivity test, using Schiff Sensitivity Scale (SSS) after 8 weeks

  8 Weeks

Study Arms (1)

Clinical trials with a single arm

EXPERIMENTAL

: Participants will be treated with desensitizing toothpaste containing zinc-carbonate hydroxyapatite nanocrystals (Zn-CHA) for 8 weeks.

Other: Single arm clinical study

Interventions

Single arm clinical study OTHER

Participants will be treated with desensitizing toothpaste containing zinc-carbonate hydroxyapatite nanocrystals (Zn-CHA) for 8 weeks.

Clinical trials with a single arm

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qassim University: lead

Study Sites (1)

College of Dentistry Qassim University

Buraidah, Al Qassim, 51452, Saudi Arabia

Location

Study Officials

• Dhafer Al Asmari, Board

  Qassim University

  PRINCIPAL INVESTIGATOR

• Muhammad K Khan, PhD

  Qassim University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Clinical trials with a single arm: Participants will be treated with desensitizing toothpaste containing zinc-carbonate hydroxyapatite nanocrystals (Zn-CHA) for 8 weeks.

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: September 16, 2019
• Study Start: January 18, 2019
• Primary Completion: July 29, 2019
• Study Completion: August 26, 2019
• Last Updated: September 16, 2019

Record last verified: 2019-09

Locations

SA (1)