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

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

Study Overview

• Status: Completed
• Conditions: Dentin Hypersensitivity
• Intervention / Treatment: Drug: Olinanoseal; Drug: Curodont D'senz

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dental Medicine for Girls, Al-Azhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Totally removed smear layer; Smear layer is completely removed by etchant of phosphoric acid	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.; Other Names: silicone polymer protector varnish; Drug: Curodont D'senz; This agent contains p 11-4 peptide in addition to fluoride; Other Names: Self assembling peptide containing desensitizing agent
Other: Partially removed smear layer; Smear layer is partially removed by etchant of phosphoric acid	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.; Other Names: silicone polymer protector varnish; Drug: Curodont D'senz; This agent contains p 11-4 peptide in addition to fluoride; Other Names: Self assembling peptide containing desensitizing agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Study Chair: Asmaa A mosleh, lecturer, lecturer, faculty of dental medicine, Al-Azhar university

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2020
• Primary Completion (Actual): November 23, 2020
• Study Completion (Actual): January 12, 2021

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: November 14, 2021
• First Posted (Actual): November 16, 2021

Study Record Updates

• Last Update Posted (Actual): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 14, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Dentin Hypersensitivity; OLiNano SEAL; Curodont D'Senz; Dye penetration; Dentin permeability
• Additional Relevant MeSH Terms: Immune System Diseases; Stomatognathic Diseases; Tooth Diseases; Hypersensitivity; Dentin Sensitivity
• Other Study ID Numbers: OPDENT A13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No