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Completed

NCT Number: NCT03285360

Effectiveness of Bioactiveglass Air Abrasion Versus Fluoride Varnish in Management of Dentin Hypersensitivity

Will the use of Bioactive glass with air abrasion technology (Sylc) compared to Fluoride Varnish (Biflourid 10) affects the degree of pain in patients complaining from hypersensitivity due to non-carious lesions?

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Key information

Conditions

Hypersensitivity Dentin Dentin Sensitivity Hypersensitivity Immune System Diseases Stomatognathic Diseases Tooth Diseases Tooth Hypersensitivity

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Faculty of dentistry

Cairo, Cairo Governorate, Egypt

About this study

  • Population: Patients complaining from Dentin Hypersensitivity due to non-carious lesions.
  • Intervention: Sylc, Air Abrasion Bioactive glass (Denfotex Research Ltd.)
  • Comparison: BiFlourid 10, Fluoride Varnish (VOCO, Germany)
  • Outcome measures: Dentin Hypersensitivity

Outcome name Measuring device Measuring unit Dentin Hypersensitivity

  • Thermal
  • Tactile
  • Evaporative

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Males or females.
  • Age: 18-70 years old.
  • Patients with good oral hygiene.
  • Co-operative patients who show interest to participate in the study.

Exclusion criteria

  • Patients with bad oral hygiene.
  • Patients with orthodontic appliances, or bridge work that might interfere with evaluation.
  • Patients who did any periodontal surgeries within the previous 6 months.
  • Patients who are allergic to any ingredients will be used in the study.
  • Pregnant and lactating women.

Treatment and study plan

Sylc

Combination Product

a dry powder (calcium sodium phosphosilicate), based on NovaMin powder. Bottle of small and coarse particles will be used for the treatment

Other names: Sylc bioactive glass

fluoride varnish (Bifluorid 10)

Combination Product

It is a rapid- drying suspension of equal amounts of sodium fluoride and calcium fluoride.

Other names: Bifluorid 10

Primary outcomes

  1. Pain due to dentin hypersensitivity (evaporative stimulus)

    Time frame: 2 minutes after treatment

    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by air blast measured by a 10 cm visual analogue scale VAS

Secondary outcomes

  1. Pain due to dentin hypersensitivity (evaporative stimulus)

    Time frame: 1 week

    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by air blast measured by a 10 cm visual analogue scale VAS

  2. Pain due to dentin hypersensitivity (evaporative stimulus)

    Time frame: 2 weeks

    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by air blast measured by a 10 cm visual analogue scale VAS

  3. Pain due to dentin hypersensitivity (evaporative stimulus)

    Time frame: 3 weeks

    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by air blast measured by a 10 cm visual analogue scale VAS

  4. Pain due to dentin hypersensitivity (evaporative stimulus)

    Time frame: 4 weeks

    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by air blast measured by a 10 cm visual analogue scale VAS

  5. Pain due to dentin hypersensitivity (evaporative stimulus)

    Time frame: 6 months

    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by air blast measured by a 10 cm visual analogue scale VAS

  6. Pain due to dentin hypersensitivity (evaporative stimulus)

    Time frame: 12 months

    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by air blast measured by a 10 cm visual analogue scale VAS

  7. Pain due to dentin hypersensitivity (tactile stimulus)

    Time frame: 2 minutes after treatment

    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by tactile stimulation with a probe measured by a 10 cm visual analogue scale VAS

  8. Pain due to dentin hypersensitivity (tactile stimulus)

    Time frame: 1 week

    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by tactile stimulation with a probe measured by a 10 cm visual analogue scale VAS

  9. Pain due to dentin hypersensitivity (tactile stimulus)

    Time frame: 2 weeks

    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by tactile stimulation with a probe measured by a 10 cm visual analogue scale VAS

  10. Pain due to dentin hypersensitivity (tactile stimulus)

    Time frame: 3 weeks

    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by tactile stimulation with a probe measured by a 10 cm visual analogue scale VAS

  11. Pain due to dentin hypersensitivity (tactile stimulus)

    Time frame: 4 weeks

    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by tactile stimulation with a probe measured by a 10 cm visual analogue scale VAS

  12. Pain due to dentin hypersensitivity (tactile stimulus)

    Time frame: 6 months

    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by tactile stimulation with a probe measured by a 10 cm visual analogue scale VAS

  13. Pain due to dentin hypersensitivity (tactile stimulus)

    Time frame: 12 months

    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by tactile stimulation with a probe measured by a 10 cm visual analogue scale VAS

  14. Pain due to dentin hypersensitivity (thermal stimulus)

    Time frame: 2 minutes after treatment

    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by cold water measured by a 10 cm visual analogue scale VAS

  15. Pain due to dentin hypersensitivity (thermal stimulus)

    Time frame: 1 week

    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by cold water measured by a 10 cm visual analogue scale VAS

  16. Pain due to dentin hypersensitivity (thermal stimulus)

    Time frame: 2 weeks

    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by cold water measured by a 10 cm visual analogue scale VAS

  17. Pain due to dentin hypersensitivity (thermal stimulus)

    Time frame: 3 weeks

    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by cold water measured by a 10 cm visual analogue scale VAS

  18. Pain due to dentin hypersensitivity (thermal stimulus)

    Time frame: 4 weeks

    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by cold water measured by a 10 cm visual analogue scale VAS

  19. Pain due to dentin hypersensitivity (thermal stimulus)

    Time frame: 6 months

    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by cold water measured by a 10 cm visual analogue scale VAS

  20. Pain due to dentin hypersensitivity (thermal stimulus)

    Time frame: 12 months

    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by cold water measured by a 10 cm visual analogue scale VAS

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effectiveness of Sylc Air Abrasion Bioactive Glass Technology Versus Fluoride Varnish Application in Management of Hypersensitivity of Non-Carious Cervical Lesions: Randomized Clinical Trial.

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Sep 18, 2017
Registry last updated
Jan 31, 2019

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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