Clinical Assessment of Bifluorid 10 vs Varnish Fluoride on The Exposed Hypersensitive Cervical Dentin in Adult Patient

Dentin Sensitivity Clinical Trial

Official title:

Quantitative Clinical Assessment of Bifluorid 10 Versus Varnish Fluoride on The Exposed Hypersensitive Cervical Dentin in Adult Patient: A Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04485299
• Other study ID #: OPR 20/7/2020
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: October 2020
• Est. completion date: January 2021

Study information

• Verified date: July 2020
• Source: Cairo University
• Contact: Zaid Yousef Alkhatteb, BSc
• Phone: 00201272111897
• Email: zaid_yousef[@]denstistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim of the study will be conducted to compare the efficacy of bifluoride (NaF and CaF) versus conventional fluoride varnish (Sodium Flouride) in the management of hypersensitivity of exposed cervical area in adult patients over 2 month

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 68
• Est. completion date: January 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy patient with free medical history.

• Age range 18-60 years old.

• Good oral hygiene

• Patients suffering from pain due to dentin hypersensitivity.

• Patient with sound first molar .

Exclusion Criteria:

• Patients using desensitizing agents, receiving periodontal treatment or had received nonsurgical periodontal treatment in the last three months.

• Patient wearing orthodontic appliance.

• Patient with teeth having a painful condition involving the pulp and periapical region.

• Patients who had allergy to materials will be used in the study.

• Pregnancy.

• Patient who does not consent to participation.

• Patient who does not attend to the follow up.

• A patient who has a carious first molar.

Related Conditions & MeSH terms

• Dentin Sensitivity
• Hypersensitivity

Intervention

Drug:
• Bifluorid 10 ,VOCO
NaF and CaF 10 %
• Sodium Fluoride 5% Dental Varnish
5% NaF

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dentin hypersensitivity	measurement of dentin hypersensitivity by VAS scale	pre-intervention
Primary	Dentin hypersensitivity	measurement of dentin hypersensitivity by VAS scale	2 min
Primary	Dentin hypersensitivity	measurement of dentin hypersensitivity by VAS scale	1 week
Primary	Dentin hypersensitivity	measurement of dentin hypersensitivity by VAS scale	4 weeks
Primary	Dentin hypersensitivity	measurement of dentin hypersensitivity by VAS scale	8 weeks
Secondary	Dentinal tubule occlusion	Percentage of dentinal tubule occlusion measure by scanning electron microscope SEM	Pre-intervention
Secondary	Dentinal tubule occlusion	Percentage of dentinal tubule occlusion measure by scanning electron microscope SEM	8 weeks