The Effect of Using Desensitizers Containing S-PRG In Treatment Of Dentin Hypersensitivity Over 6 Months: A Randomized Clinical Trial

Dentin Hypersensitivity Clinical Trial

— S-PRG  

Official title:

The Effect of Using Desensitizers Containing S-PRG Versus Sodium Fluoride With Functionalized Tri-Calcium Phosphate In Treatment Of Dentin Hypersensitivity In Adult Patients Over 6 Months: A Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06276777
• Other study ID #: SPRG Dentin Hypersensitivity
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: Eman Omar El-farouk, masters
• Phone: 01156677558
• Email: eman.omar[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare the effect of desensitizer containing S-PRG have similar effect as sodium fluoride with functionalized tri-calcium phosphate containing desensitizer in relieving dentinal hypersensitivity in adult patients for six months follow-up. patients will be asked to report pain degree on the visual analogue scale (VAS) along the follow up periods on both groups.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Good oral hygiene.
• Cooperative patients who show interest to participate in the study and welling to sign the informed consent.
• Healthy patients with no history of previous systematic diseases that can affect their oral health.
• Normal and healthy gingival tissue.
• Teeth that have no cavitation or restorations.
• Patients with at least 20 natural permanent teeth and at least two teeth with a VAS score from 4 to 10.
• Anterior teeth.

Exclusion Criteria:

• Allergic to the ingredients used in the study.
• Gastrointestinal disorders (They have repeated vomiting attacks).
• Medically compromised (They cannot tolerate the procedures).
• Taking desensitizing treatment in the last 6 months (It affects the outcome).
• Taking anti-inflammatory drugs (It affects the hypersensitivity perception).
• Pregnant females (They complain from nausea and repeated vomiting attacks)
• Smokers (Smoking will affect the oral hygiene and periodontal health).

Related Conditions & MeSH terms

• Dentin Hypersensitivity
• Dentin Sensitivity
• Hypersensitivity

Intervention

Procedure:
• Tooth varnish (PRG Barrier Coat from Shofu)
Treatment of cervical dentin hypersensitivity with tooth desensitizers.
• Tooth varnish (Clinpro white varnish 3M)
Treatment of cervical dentin hypersensitivity with tooth desensitizers.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Eman Omar Elfarouk

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dentin hypersensitivity reduction	The participants will point out the degree of sensitivity on the VAS scale (0-10) chart.	assessment will be done immediately after the treatment then after 1 week, 4 weeks, 3 months and 6 months.