NCT04731766

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 1, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

October 6, 2020

Last Update Submit

January 29, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • change in dentinal Tubule Occlusion

    1 week, 4 weeks * 8 weeks

Study Arms (2)

Citrine 5% Sodium Fluoride

ACTIVE COMPARATOR

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

concocuted Nano-silver fluoride

EXPERIMENTAL

Nano-silver fluoride (NSF) is a laboratory synthesized solution

Behavioral: concocted nano-silver fluoride

Interventions

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.

Citrine 5% Sodium 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.

concocuted Nano-silver fluoride

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Sodium Fluoride

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

FluoridesHydrofluoric AcidFluorine CompoundsInorganic ChemicalsSodium CompoundsCariostatic AgentsBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

October 6, 2020

First Posted

February 1, 2021

Study Start

November 1, 2021

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

February 1, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share