Effect of Using Different Varnishes on Dentin Hypersensitivity; Na Fluoride and Nano-silver Fluoride

Effectiveness of Using Nano-Silver Fluoride Varnish Versus Sodium Fluoride Varnish in Management of Cervical Dentin Hypersensitivity in Adult Patients: A Randomized Clinical Trial.

2 different varnishes will be used to test their effectiveness in controlling teeth hypersensitivity in adult patient.

Study Overview

• Status: Unknown
• Conditions: Dentin Hypersensitivity
• Intervention / Treatment: Behavioral: Citrine 5 % sodium fluoride; Behavioral: concocted nano-silver fluoride

Detailed Description

In-vivo part:

Each varnish will be applied separately on different teeth according to the manufacturer's instructions and the VAS will be measured according to a specific timeline: T0 (baseline, before application of varnish), T1 (1 week after application), T2 (4 weeks after application) and T3 (4 weeks after application).

In-situ part:

Dentin specimen will be prepared from extracted teeth from the orthodontic department in our college, sterilized and prepared.

it will be bonded to an orthodontic wire and bonded to upper first molar. Dentinal occlusion will be measured using scanning electron microscope following the same timeline.

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients consulting in one of the Qasr Einy, faculty of dentistry outpatient clinics.
• Males or females.
• Patient's age range 25-50 years.
• Patients complaining of hypersensitive areas on facial surfaces of the teeth (incisors, cuspids, bi-cuspids, and first molars with exposed cervical dentine) with teeth scoring Bpain (VAS score: greater than or equal to 3) during application of stimulus (airblast and tactile sensitivity test).
• Tooth with exposed root surface, complaining from hypersensitivity (VAS score; greater than or equal to 3).
• Patients accept the 2-months follow-up period.
• Provide informed consent.

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.
  • Lack of patient's approval and compliance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Citrine 5% Sodium Fluoride; It was developed to prolong the contact between the tooth surface and fluoride to increase the resistance against caries attack and manage tooth hypersensitivity; the active ingredient of fluoride varnish is mostly 5% sodium fluoride.	Behavioral: Citrine 5 % sodium fluoride; Citrine varnish is a 5% sodium fluoride varnish, It was developed to prolong the contact between the tooth surface and fluoride to increase the resistance against caries attack and manage tooth hypersensitivity; the active ingredient of fluoride varnish is mostly 5% sodium fluoride.
EXPERIMENTAL: concocuted Nano-silver fluoride; Nano-silver fluoride (NSF) is a laboratory synthesized solution	Behavioral: concocted nano-silver fluoride; Nano-silver fluoride (NSF) is a solution which has been introduced as an experimental formulation in which it's stability for three years has been proved by Santos et al. The laboratory synthesis of concocted NSF was carried out in a nano-technology center; Several trials were done until we have reached a successful end product.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in dentin Hypersensitivity	Visual Analogue Scale (VAS) will be used; 0 is no pain and 10 is severe pain. Pictures are added to the same, as well as colors to guide the patient during selection of pain severity.	1 week, 4 weeks & 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in dentinal Tubule Occlusion	the dentinal tubule occlusion of citrine 5% sodium fluoride and the dentinal tubule occlusion of nano-silver fluoride for treatment of dentin hypersensitivity and compare them together	1 week, 4 weeks * 8 weeks

Collaborators and Investigators

• Sponsor: Nayera Hassanien Mohamed

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2021
• Primary Completion (ANTICIPATED): January 1, 2022
• Study Completion (ANTICIPATED): January 1, 2022

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: January 29, 2021
• First Posted (ACTUAL): February 1, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 29, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Stomatognathic Diseases; Tooth Diseases; Hypersensitivity; Dentin Sensitivity; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Listerine; Fluorides; Sodium Fluoride
• Other Study ID Numbers: 205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No