Effectiveness of Bioactive Resin Varnish and Fluoride Containing Xylitol Varnish in Management of Teeth Hypersensitivity

Cairo University (CU)

Status: Completed

Conditions: Tooth Hypersensitivity

Treatments: Other: PRG Barrier Coat (By SHOFU Inc., Japan); Other: EMBRACE™ Varnish by (Pulpdent Corporation, USA)

Study type: Interventional

Funder types: Other

Identifiers

NCT04568473

CairoU-HAElFattah

Details and patient eligibility

About

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?

Full 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

Enrollment: 63 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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63 participants in 3 patient groups

PRG Barrier Coat (SHOFU Inc., Japan)

Experimental group

Description:

BioSmart Light Cured Protective Shield with bioactive S-PRG (Surface Pre-Reacted Glass ionomer) filler technology. S-PRG filler possesses a three-layer structure with a stabilized glass-ionomer-like structure surrounding multifunctional glass fillers, and is subsequently protected by a surface modified layer.

Treatment:

Other: EMBRACE™ Varnish by (Pulpdent Corporation, USA)

EMBRACE™ Varnish (Pulpdent Corporation, USA)

Experimental group

Description:

Resin-based 5% sodium fluoride with CXP™ (Xylitol-coated Calcium and Phosphate) technology for unsurpassed fluoride release. The incorporation of CXP™ (xylitol-coated calcium and phosphate) in a permeable resin matrix that does not separate, purportedly drives the sustained, time-released properties of this varnish

Treatment:

Other: PRG Barrier Coat (By SHOFU Inc., Japan)

Duraphat® (Colgate Palmolive Company, New York, NY)

Active Comparator group

Description:

It is attributed to the reactivity of the fluoride by adsorbing to the surface and attracting calcium ions forming loosely-bound calcium fluoride (CaF2)- like reservoir which is also considered responsible for the anticaries mechanism and protection against cariogenic acid attack.

Treatment:

Other: EMBRACE™ Varnish by (Pulpdent Corporation, USA)

Other: PRG Barrier Coat (By SHOFU Inc., Japan)