Back to resultsEffect of Using Different Varnishes on Dentin Hypersensitivity; Na Fluoride and Nano-silver Fluoride
Primary Purpose
Dentin Hypersensitivity
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Citrine 5 % sodium fluoride
concocted nano-silver fluoride
Sponsored by
About this trial
This is an interventional treatment trial for Dentin Hypersensitivity
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Citrine 5% Sodium Fluoride
concocuted Nano-silver fluoride
Arm Description
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.
Nano-silver fluoride (NSF) is a laboratory synthesized solution
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04731766
First Posted
October 6, 2020
Last Updated
January 29, 2021
Sponsor
Nayera Hassanien Mohamed
1. Study Identification
Unique Protocol Identification Number
NCT04731766
Brief Title
Effect of Using Different Varnishes on Dentin Hypersensitivity; Na Fluoride and Nano-silver Fluoride
Official Title
Effectiveness of Using Nano-Silver Fluoride Varnish Versus Sodium Fluoride Varnish in Management of Cervical Dentin Hypersensitivity in Adult Patients: A Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2021 (Anticipated)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nayera Hassanien Mohamed
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
2 different varnishes will be used to test their effectiveness in controlling teeth hypersensitivity in adult patient.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Hypersensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Citrine 5% Sodium Fluoride
Arm Type
Active Comparator
Arm Description
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.
Arm Title
concocuted Nano-silver fluoride
Arm Type
Experimental
Arm Description
Nano-silver fluoride (NSF) is a laboratory synthesized solution
Intervention Type
Behavioral
Intervention Name(s)
Citrine 5 % sodium fluoride
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
concocted nano-silver fluoride
Intervention Description
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.
Primary Outcome Measure Information:
Title
change in dentin Hypersensitivity
Description
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.
Time Frame
1 week, 4 weeks & 8 weeks
Secondary Outcome Measure Information:
Title
change in dentinal Tubule Occlusion
Description
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
Time Frame
1 week, 4 weeks * 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Using Different Varnishes on Dentin Hypersensitivity; Na Fluoride and Nano-silver Fluoride
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