Clinical trial NCT03285360: Effectiveness of Bioactiveglass Air Abrasion Versus Fluoride Varnish in Management of Dentin Hypersensitivity
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypersensitivity Dentin
Tooth Hypersensitivity
Keywords: Bifluoride, sylc, hypersensitivity,
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-09-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Dentin Hypersensitivity
Primary purpose: TREATMENT

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?

Detailed description: * 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

Eligibility criteria: 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.

Primary outcomes:
measure: Pain due to dentin hypersensitivity (evaporative stimulus)
timeFrame: 2 minutes after treatment
Secondary outcomes:
measure: Pain due to dentin hypersensitivity (evaporative stimulus)
timeFrame: 1 week
measure: Pain due to dentin hypersensitivity (evaporative stimulus)
timeFrame: 2 weeks
measure: Pain due to dentin hypersensitivity (evaporative stimulus)
timeFrame: 3 weeks
measure: Pain due to dentin hypersensitivity (evaporative stimulus)
timeFrame: 4 weeks
measure: Pain due to dentin hypersensitivity (evaporative stimulus)
timeFrame: 6 months
measure: Pain due to dentin hypersensitivity (evaporative stimulus)
timeFrame: 12 months
measure: Pain due to dentin hypersensitivity (tactile stimulus)
timeFrame: 2 minutes after treatment
measure: Pain due to dentin hypersensitivity (tactile stimulus)
timeFrame: 1 week
measure: Pain due to dentin hypersensitivity (tactile stimulus)
timeFrame: 2 weeks
measure: Pain due to dentin hypersensitivity (tactile stimulus)
timeFrame: 3 weeks
measure: Pain due to dentin hypersensitivity (tactile stimulus)
timeFrame: 4 weeks
measure: Pain due to dentin hypersensitivity (tactile stimulus)
timeFrame: 6 months
measure: Pain due to dentin hypersensitivity (tactile stimulus)
timeFrame: 12 months
measure: Pain due to dentin hypersensitivity (thermal stimulus)
timeFrame: 2 minutes after treatment
measure: Pain due to dentin hypersensitivity (thermal stimulus)
timeFrame: 1 week
measure: Pain due to dentin hypersensitivity (thermal stimulus)
timeFrame: 2 weeks
measure: Pain due to dentin hypersensitivity (thermal stimulus)
timeFrame: 3 weeks
measure: Pain due to dentin hypersensitivity (thermal stimulus)
timeFrame: 4 weeks
measure: Pain due to dentin hypersensitivity (thermal stimulus)
timeFrame: 6 months
measure: Pain due to dentin hypersensitivity (thermal stimulus)
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry
state: Cairo Governorate
Study officials:
affiliation: Assistant lecturer, Conservative Dentistry Department, Faculty of Dentistry, Cairo University
name: Dina E Mohamed, Master
role: PRINCIPAL_INVESTIGATOR
References: