Comparative Study on the Efficacy of OliNano SEAL and Curodont D' Senz in Treatment of Dentin Hypersensitivity

Dentin Hypersensitivity Clinical Trial

Official title:

Comparative Study on the Efficacy of OliNano SEAL and Curodont D' Senz in Treatment of Dentin Hypersensitivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05122312
• Other study ID #: OPDENT A13
• Status: Completed
• Phase: Phase 4
• Start date: April 20, 2020
• Est. completion date: January 12, 2021

Study information

• Verified date: November 2021
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was conducted to evaluate and compare the efficacy of Olinanoseal and Curodont D'Senz in treatment of dentin hypersensitivity.

Description:

Materials and Methods:- A total of ninety (90) samples were used in the study, for dentin permeability test (dye penetration test) and Scanning Electron Microscopic examination (SEM) which were randomly divided into two main groups; group A1, completely removed smear layer, group A2, partially removed smear layer. Each group was subdivided into three subgroups according to the desensitizing agent applied: OliNano SEAL, Curodont D'Senz and the control group that were left untreated. Seventy (70) hypersensitive teeth in ten patients were enrolled for the current study. The subjective assessment of dentin hypersensitivity was done prior to the application of the desensitizing agent (baseline) then immediately, 2 weeks, 4 weeks and 3 months after application of the tested materials. Patients were informed to rate their perception to tactile, air and cold stimuli by using Verbal Rating Score (VRS) and Visual Analogue Scale (VAS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 12, 2021
• Est. primary completion date: November 23, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Presence of a minimum of four hypersensitive teeth in each patient.

2. Patients with teeth recorded a discomfort score of two or more to tactile, cold and air stimulation.

3. Teeth having hypersensitivity only on the facial aspect.

4. Patients' willingness to participate in the study

Exclusion Criteria:

1. Patients with any medical or dental condition that could impact the study results during its expected length.

2. Patients with a history of drug addictions and use of potent analgesic and/ or anti-inflammatory drugs.

3. Patients who refused to give their consents.

4. Patients with any extensive or unsatisfactory restorations, prosthesis or orthodontic appliances which involve the cervical areas

Related Conditions & MeSH terms

• Dentin Hypersensitivity
• Dentin Sensitivity
• Hypersensitivity

Intervention

Drug:
• Olinanoseal
it contains nanometer particles of fluoroapatite and calcium fluoride - guarantees the resistance to cracks and abrasion. At the same time insoluble nano-fluoroapatites fill all enamel microcracks and closes open dentinal tubules.
• Curodont D'senz
This agent contains p 11-4 peptide in addition to fluoride

Locations

Country	Name	City	State
Egypt	Faculty of dental Medicine for girls, Al-AZhar University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dentin hypersensitivity	pain score (visual analogue scale VAS ["minmum =0 {best}, maximum=10 {worst}] and verbal rating scale VRS ["minmum =0 {best}, maximum=4 {worst}])	2 minutes
Primary	dentin hypersensitivity	pain score (visual analogue scale VAS ["minmum =0 {best}, maximum=10 {worst}] and verbal rating scale VRS ["minmum =0 {best}, maximum=4 {worst}])	2 weeks
Primary	dentin hypersensitivity	pain score (visual analogue scale VAS ["minmum =0 {best}, maximum=10 {worst}]) and verbal rating scale VRS ["minmum =0 {best}, maximum=4 {worst}])	4 weeks
Primary	dentin hypersensitivity	pain score (visual analogue scale VAS ["minmum =0 {best}, maximum=10 {worst}] and verbal rating scale VRS ["minmum =0 {best}, maximum=4 {worst}])	3 months