Clinical trial NCT04568473: Effectiveness of Bioactive Resin Varnish and Fluoride Containing Xylitol Varnish in Management of Teeth Hypersensitivity
Official title: Effectiveness of Bioactive Resin Based Varnish and Fluoride Varnish Containing Xylitol-coated Particles Versus Sodium Fluoride Varnish in Management of Teeth Hypersensitivity in Adult Patients Over Eight Weeks: a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Hypersensitivity
Keywords: Hypersensitivity
Sodium Fluoride
Xylitol coated Calcium and Phosphate
BioSmart Light Cured Protective Shield
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-09-29
Enrollment: 63
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Will the use of Bio-smart Light Cured Protective Shield with bioactive S-PRG filler or the use of Sodium Fluoride with Xylitol-coated Calcium and Phosphate (CXP™) Varnish be able to reduce the teeth hypersensitivity similar to Sodium Fluoride Varnish?

Detailed description: The null hypothesis tested in this study, that there is no difference in clinical effectiveness between bio-smart Shield with bioactive S-PRG filler and Fluoride varnish containing Xylitol-coated Calcium and Phosphate (CXP™) Compared to Sodium Fluoride Varnish in management of hypersensitivity in adult patients after 3 minutes, 2, 4 and 8 weeks.

P (Population): Patient with Teeth Hypersensitivity.

Intervention-1: Bio-smart Light Cured Protective Shield with bioactive S-PRG (Surface Pre-Reacted Glass ionomer) filler technology (PRG Barrier Coat) by (By SHOFU Inc., Japan).

Intervention-2: 5% Sodium Fluoride with Xylitol-coated Calcium and Phosphate (CXP™) Varnish (Embrace™ Varnish) by (Pulpdent Corporation)

C (Comparator): 5% Sodium Fluoride Varnish (Duraphat®) by (Colgate Palmolive Company, New York, NY)

O (Outcome):

* Primary Outcome: Pain due to Hypersensitivity
* Secondary Outcome: Dentinal tubules occlusion

Eligibility criteria: Inclusion Criteria:

* Patients complaining of hypersensitive areas on facial surfaces of the teeth (incisors, cuspids, bicuspids, and first molars with exposed cervical dentin)

  * Teeth scoring pain (VAS score: greater than or equal to 5) during application of stimulus (air blast, thermal and tactile sensitivity test).
  * Patients with good oral hygiene.
  * Co-operative patients who show interest to participate in the study accept the 2-months follow-up period.

Exclusion Criteria:

* Patients participating in another dental study that may alter the results of this study.
* A medical condition that could hinder the accuracy of pain reporting (e.g., pain disorders).
* Any chronic medical condition that requires the regular use of anti-inflammatory pain medications.
* Patients used or applied a desensitizing varnish within the last four weeks.
* Patients with dental problems; chipped teeth, defective restorations, fractured Un-displaced cuspids or deep dental caries.
* Patients with orthodontic appliances, or bridge work that might interfere with evaluation
* Lack of patient's approval and compliance.
* Patients who are allergic to any ingredients will be used in the study.

Primary outcomes:
measure: Amount of pain due to dentin hypersensitivity (evaporative stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
timeFrame: Baseline
measure: Amount of pain due to dentin hypersensitivity (evaporative stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
timeFrame: 3 minutes
measure: Amount of pain due to dentin hypersensitivity (evaporative stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
timeFrame: 2 weeks
measure: Amount of pain due to dentin hypersensitivity (evaporative stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
timeFrame: 4 weeks
measure: Amount of pain due to dentin hypersensitivity (evaporative stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
timeFrame: 8 weeks
Secondary outcomes:
measure: Amount of pain due to dentin hypersensitivity (Thermal stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
timeFrame: Baseline
measure: Amount of pain due to dentin hypersensitivity (Thermal stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
timeFrame: 3 minutes
measure: Amount of pain due to dentin hypersensitivity (Thermal stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
timeFrame: 2 weeks
measure: Amount of pain due to dentin hypersensitivity (Thermal stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
timeFrame: 4 weeks
measure: Amount of pain due to dentin hypersensitivity (Thermal stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
timeFrame: 8 weeks
measure: Amount of pain due to dentin hypersensitivity (Tactile stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
timeFrame: Baseline
measure: Amount of pain due to dentin hypersensitivity (Tactile stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
timeFrame: 3 minutes
measure: Amount of pain due to dentin hypersensitivity (Tactile stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
timeFrame: 2 weeks
measure: Amount of pain due to dentin hypersensitivity (Tactile stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
timeFrame: 4 weeks
measure: Amount of pain due to dentin hypersensitivity (Tactile stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
timeFrame: 8 weeks
measure: Dentinal Tubule Occlusion
timeFrame: Baseline
measure: Dentinal Tubule Occlusion
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
state: Manial
Study officials:
affiliation: Cairo University
name: Heba AE Mohamed, Master's
role: PRINCIPAL_INVESTIGATOR
References: