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Completed

NCT Number: NCT04472182

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

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.

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Key information

Conditions

Hypersensitivity Immune System Diseases

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cairo U

Giza, 12311, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Fluoride varnish with xylitol coated calcium and phosphate

Drug

Fluoride varnish with xylitol coated calcium and phosphate

Primary outcomes

  1. Pain due to Dentin Hypersensitivity

    Time frame: Two minutes before intervention

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

  2. Pain due to Dentin Hypersensitivity

    Time frame: 4 hours

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

  3. Pain due to Dentin Hypersensitivity

    Time frame: 2 days

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

  4. Pain due to Dentin Hypersensitivity

    Time frame: 4 months

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

  5. Pain due to Dentin Hypersensitivity

    Time frame: 8 months

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

  6. Pain due to Dentin Hypersensitivity

    Time frame: 12 months

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

Secondary outcomes

  1. Measuring Salivary pH

    Time frame: Two minutes before intervention

    measuring Unstimulated Salivary pH using pH meter from 0-14

  2. Measuring Salivary pH

    Time frame: 4 hours

    measuring Unstimulated Salivary pH using pH meter from 0-14

  3. Measuring Salivary pH

    Time frame: 2 days

    measuring Unstimulated Salivary pH using pH meter from 0-14

  4. Measuring Salivary pH

    Time frame: 4 months

    measuring Unstimulated Salivary pH using pH meter from 0-14

  5. Measuring Salivary pH

    Time frame: 8 months

    measuring Unstimulated Salivary pH using pH meter from 0-14

  6. Measuring Salivary pH

    Time frame: 12 months

    measuring Unstimulated Salivary pH using pH meter from 0-14

  7. Image analysis to assess amount of plaque adherence

    Time frame: 2 minutes before intervention

    Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface

  8. Image analysis to assess amount of plaque adherence

    Time frame: 4 hours

    Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface

  9. Image analysis to assess amount of plaque adherence

    Time frame: 2 days

    Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface

  10. Image analysis to assess amount of plaque adherence

    Time frame: 4 months

    Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface

  11. Image analysis to assess amount of plaque adherence

    Time frame: 8 months

    Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface

  12. Image analysis to assess amount of plaque adherence

    Time frame: 12 months

    Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 15, 2020
Registry last updated
Jan 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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