Clinical trial 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
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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypersensitivity
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-07-15
Enrollment: 105
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Dentin Hypersensitivity
Primary purpose: TREATMENT

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.


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.)

Primary outcomes:
measure: Pain due to Dentin Hypersensitivity
timeFrame: Two minutes before intervention
measure: Pain due to Dentin Hypersensitivity
timeFrame: 4 hours
measure: Pain due to Dentin Hypersensitivity
timeFrame: 2 days
measure: Pain due to Dentin Hypersensitivity
timeFrame: 4 months
measure: Pain due to Dentin Hypersensitivity
timeFrame: 8 months
measure: Pain due to Dentin Hypersensitivity
timeFrame: 12 months
Secondary outcomes:
measure: Measuring Salivary pH
timeFrame: Two minutes before intervention
measure: Measuring Salivary pH
timeFrame: 4 hours
measure: Measuring Salivary pH
timeFrame: 2 days
measure: Measuring Salivary pH
timeFrame: 4 months
measure: Measuring Salivary pH
timeFrame: 8 months
measure: Measuring Salivary pH
timeFrame: 12 months
measure: Image analysis to assess amount of plaque adherence
timeFrame: 2 minutes before intervention
measure: Image analysis to assess amount of plaque adherence
timeFrame: 4 hours
measure: Image analysis to assess amount of plaque adherence
timeFrame: 2 days
measure: Image analysis to assess amount of plaque adherence
timeFrame: 4 months
measure: Image analysis to assess amount of plaque adherence
timeFrame: 8 months
measure: Image analysis to assess amount of plaque adherence
timeFrame: 12 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo U
Study officials:
affiliation: Cairo University
name: Peter E Abdelmalik, Master
role: PRINCIPAL_INVESTIGATOR
References: