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NCT04472182 Clinical Trial

Efficacy of Fluoride Varnish Containing Xylitol Coated Calcium Phosphate Versus Conventional Fluoride Varnish in Management of Hypersensitivity of Exposed Root Surfaces in Adult Patients

Hypersensitivity Clinical Trial

Official title:
Efficacy of Fluoride Varnish Containing Xylitol Coated Calcium Phosphate Versus Conventional Fluoride Varnish in Management of Hypersensitivity of Exposed Root Surfaces in Adult Patients: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04472182
Other study ID # CairoUniv
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date December 20, 2020
Est. completion date December 21, 2021

Study information
Verified date January 2022
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This clinical trial will be conducted to compare the efficacy of fluoride varnish containing xylitol coated calcium and phosphate or potassium nitrate gel versus conventional fluoride varnish in the management of hypersensitivity of non-carious exposed root surfaces in adult patients over a 12 months period.

Recruitment information / eligibility
Status Completed
Enrollment 105
Est. completion date December 21, 2021
Est. primary completion date December 21, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria of participants: Males or females. Age: 20-50 years old. Patients having at least one tooth with exposed root surface Teeth with hypersensitivity, VAS =5 Patients with good oral hygiene. Co-operative patients who show interest to participate in the study Exclusion criteria of participants: Patients with bad oral hygiene Patients with orthodontic appliances, or bridge work that might interfere with evaluation Patients who are allergic to any ingredients will be used in the study. Carious teeth Mobile teeth. (Grade 2 or Grade 3) Teeth with hypersensitivity, VAS <5 Patients with physical disabilities Pregnant or lactating women Other dental defects that causes pain. Allergy from any used materials or any allergic reaction during our clinical trial (The trial will be stopped at once and all the needed management against any allergic reaction will be done.)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Fluoride varnish with xylitol coated calcium and phosphate
Fluoride varnish with xylitol coated calcium and phosphate

Locations
Country Name City State
Egypt Cairo U Giza

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain due to Dentin Hypersensitivity Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale Two minutes before intervention
Primary Pain due to Dentin Hypersensitivity Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale 4 hours
Primary Pain due to Dentin Hypersensitivity Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale 2 days
Primary Pain due to Dentin Hypersensitivity Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale 4 months
Primary Pain due to Dentin Hypersensitivity Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale 8 months
Primary Pain due to Dentin Hypersensitivity Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale 12 months
Secondary Measuring Salivary pH measuring Unstimulated Salivary pH using pH meter from 0-14 Two minutes before intervention
Secondary Measuring Salivary pH measuring Unstimulated Salivary pH using pH meter from 0-14 4 hours
Secondary Measuring Salivary pH measuring Unstimulated Salivary pH using pH meter from 0-14 2 days
Secondary Measuring Salivary pH measuring Unstimulated Salivary pH using pH meter from 0-14 4 months
Secondary Measuring Salivary pH measuring Unstimulated Salivary pH using pH meter from 0-14 8 months
Secondary Measuring Salivary pH measuring Unstimulated Salivary pH using pH meter from 0-14 12 months
Secondary Image analysis to assess amount of plaque adherence Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface 2 minutes before intervention
Secondary Image analysis to assess amount of plaque adherence Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface 4 hours
Secondary Image analysis to assess amount of plaque adherence Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface 2 days
Secondary Image analysis to assess amount of plaque adherence Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface 4 months
Secondary Image analysis to assess amount of plaque adherence Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface 8 months
Secondary Image analysis to assess amount of plaque adherence Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface 12 months
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