NCT03285360

Brief Summary

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 18, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

1.2 years

First QC Date

September 11, 2017

Last Update Submit

January 30, 2019

Conditions

Hypersensitivity DentinTooth Hypersensitivity

Keywords

Bifluoride, sylc, hypersensitivity,

Outcome Measures

Primary Outcomes (1)

  • Pain due to dentin hypersensitivity (evaporative stimulus)

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

    2 minutes after treatment

Secondary Outcomes (20)

  • Pain due to dentin hypersensitivity (evaporative stimulus)

    1 week

  • Pain due to dentin hypersensitivity (evaporative stimulus)

    2 weeks

  • Pain due to dentin hypersensitivity (evaporative stimulus)

    3 weeks

  • Pain due to dentin hypersensitivity (evaporative stimulus)

    4 weeks

  • Pain due to dentin hypersensitivity (evaporative stimulus)

    6 months

  • +15 more secondary outcomes

Study Arms (2)

sylc bioactive glass

EXPERIMENTAL

Sylc is a dry powder (calcium sodium phosphosilicate), based on NovaMin powder. Bottle of small and coarse particles will be used for the treatment. Steps: 1. Isolation: D.M. will make proper isolation for the teeth using cotton rolls. 2. Hand piece: NSK Prophymate Neo will be used to deliver the powder particles on the sensitive areas. Air stream adjusted at 40-46 psi. 3. Application: The hand piece will be held at constant distance (3-4mm) away from the tooth surface, with 60-80 degrees on the buccal surfaces. The powder will be applied for 5-10 seconds per tooth in a circular movement. 4. Suction: High volume suction will be used on lingual side of the teeth to suck any particles, and avoid patient from swallowing it.

Combination Product: Sylc

fluoride varnish (Bifluorid 10)

ACTIVE COMPARATOR

fluoride varnish Bifluorid 10(by VOCO) will be used. It is a rapid- drying suspension of equal amounts of sodium fluoride and calcium fluoride. The single dose form will be used, to make sure the amount of fluoride varnish used is standardized. Steps: 1. Preparation: The tooth will be properly cleaned, and the surface will be air-dried. 2. Dispensing: The foil will be pierced using a micro- tim, the opening will be enlarged, the brush will be wet in a circular movement. 3. Application: Thin coat will be applied on the tooth surface. The varnish will be left from 10-20 seconds then air dried. Concerning the storage of the Bifluoride 10, it will be stored in refrigerator at the operative clinic to avoid exposure to high temperature or sunlight.

Combination Product: fluoride varnish (Bifluorid 10)

Interventions

SylcCOMBINATION_PRODUCT

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

Also known as: Sylc bioactive glass
sylc bioactive glass
fluoride varnish (Bifluorid 10)COMBINATION_PRODUCT

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

Also known as: Bifluorid 10
fluoride varnish (Bifluorid 10)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Conditions

Dentin SensitivityHypersensitivity

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesImmune System Diseases

Study Officials

  • Dina E Mohamed, Master

    Assistant lecturer, Conservative Dentistry Department, Faculty of Dentistry, Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
double blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Dentin Hypersensitivity
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 11, 2017

First Posted

September 18, 2017

Study Start

October 1, 2017

Primary Completion

December 1, 2018

Study Completion

January 1, 2019

Last Updated

January 31, 2019

Record last verified: 2019-01

Locations

EG(1)