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

Primary Purpose

Hypersensitivity

Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Fluoride varnish with xylitol coated calcium and phosphate
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypersensitivity

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.)

Sites / Locations

  • Cairo U

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fluoride varnish with xylitol coated calcium and phosphate

Conventional Fluoride varnish

Arm Description

Outcomes

Primary Outcome Measures

Pain due to Dentin Hypersensitivity
Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale
Pain due to Dentin Hypersensitivity
Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale
Pain due to Dentin Hypersensitivity
Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale
Pain due to Dentin Hypersensitivity
Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale
Pain due to Dentin Hypersensitivity
Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale
Pain due to Dentin Hypersensitivity
Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale

Secondary Outcome Measures

Measuring Salivary pH
measuring Unstimulated Salivary pH using pH meter from 0-14
Measuring Salivary pH
measuring Unstimulated Salivary pH using pH meter from 0-14
Measuring Salivary pH
measuring Unstimulated Salivary pH using pH meter from 0-14
Measuring Salivary pH
measuring Unstimulated Salivary pH using pH meter from 0-14
Measuring Salivary pH
measuring Unstimulated Salivary pH using pH meter from 0-14
Measuring Salivary pH
measuring Unstimulated Salivary pH using pH meter from 0-14
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
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
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
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
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
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

Full Information

First Posted
July 11, 2020
Last Updated
January 20, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04472182
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
December 20, 2020 (Actual)
Primary Completion Date
December 21, 2021 (Actual)
Study Completion Date
December 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypersensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Dentin Hypersensitivity
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluoride varnish with xylitol coated calcium and phosphate
Arm Type
Experimental
Arm Title
Conventional Fluoride varnish
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Fluoride varnish with xylitol coated calcium and phosphate
Intervention Description
Fluoride varnish with xylitol coated calcium and phosphate
Primary Outcome Measure Information:
Title
Pain due to Dentin Hypersensitivity
Description
Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale
Time Frame
Two minutes before intervention
Title
Pain due to Dentin Hypersensitivity
Description
Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale
Time Frame
4 hours
Title
Pain due to Dentin Hypersensitivity
Description
Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale
Time Frame
2 days
Title
Pain due to Dentin Hypersensitivity
Description
Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale
Time Frame
4 months
Title
Pain due to Dentin Hypersensitivity
Description
Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale
Time Frame
8 months
Title
Pain due to Dentin Hypersensitivity
Description
Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Measuring Salivary pH
Description
measuring Unstimulated Salivary pH using pH meter from 0-14
Time Frame
Two minutes before intervention
Title
Measuring Salivary pH
Description
measuring Unstimulated Salivary pH using pH meter from 0-14
Time Frame
4 hours
Title
Measuring Salivary pH
Description
measuring Unstimulated Salivary pH using pH meter from 0-14
Time Frame
2 days
Title
Measuring Salivary pH
Description
measuring Unstimulated Salivary pH using pH meter from 0-14
Time Frame
4 months
Title
Measuring Salivary pH
Description
measuring Unstimulated Salivary pH using pH meter from 0-14
Time Frame
8 months
Title
Measuring Salivary pH
Description
measuring Unstimulated Salivary pH using pH meter from 0-14
Time Frame
12 months
Title
Image analysis to assess amount of plaque adherence
Description
Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface
Time Frame
2 minutes before intervention
Title
Image analysis to assess amount of plaque adherence
Description
Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface
Time Frame
4 hours
Title
Image analysis to assess amount of plaque adherence
Description
Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface
Time Frame
2 days
Title
Image analysis to assess amount of plaque adherence
Description
Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface
Time Frame
4 months
Title
Image analysis to assess amount of plaque adherence
Description
Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface
Time Frame
8 months
Title
Image analysis to assess amount of plaque adherence
Description
Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter E Abdelmalik, Master
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo U
City
Giza
ZIP/Postal Code
12311
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this 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

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