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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypersensitivity
• Intervention / Treatment: Drug: Fluoride varnish with xylitol coated calcium and phosphate

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 12311
    • Cairo U

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fluoride varnish with xylitol coated calcium and phosphate	Drug: Fluoride varnish with xylitol coated calcium and phosphate; Fluoride varnish with xylitol coated calcium and phosphate
Active Comparator: Conventional Fluoride varnish	Drug: Fluoride varnish with xylitol coated calcium and phosphate; Fluoride varnish with xylitol coated calcium and phosphate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring Salivary pH	measuring Unstimulated Salivary pH using pH meter from 0-14	Two minutes before intervention
Measuring Salivary pH	measuring Unstimulated Salivary pH using pH meter from 0-14	4 hours
Measuring Salivary pH	measuring Unstimulated Salivary pH using pH meter from 0-14	2 days
Measuring Salivary pH	measuring Unstimulated Salivary pH using pH meter from 0-14	4 months
Measuring Salivary pH	measuring Unstimulated Salivary pH using pH meter from 0-14	8 months
Measuring Salivary pH	measuring Unstimulated Salivary pH using pH meter from 0-14	12 months
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Peter E Abdelmalik, Master, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2020
• Primary Completion (Actual): December 21, 2021
• Study Completion (Actual): December 21, 2021

Study Registration Dates

• First Submitted: July 11, 2020
• First Submitted That Met QC Criteria: July 11, 2020
• First Posted (Actual): July 15, 2020

Study Record Updates

• Last Update Posted (Actual): January 24, 2022
• Last Update Submitted That Met QC Criteria: January 20, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity; Physiological Effects of Drugs; Protective Agents; Calcium-Regulating Hormones and Agents; Cariostatic Agents; Calcium; Fluorides; Fluorides, Topical
• Other Study ID Numbers: CairoUniv

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No