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

NCT05122312 | Completed Phase 4 DMC

• 1 other identifier: OPDENT A13
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dentin Hypersensitivity

Keywords

OLiNano SEAL; Curodont D'Senz; Dentin Hypersensitivity; Dye penetration; Dentin permeability

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Totally removed smear layer

OTHER

Smear layer is completely removed by etchant of phosphoric acid

Drug: Olinanoseal; Drug: Curodont D'senz

Partially removed smear layer

OTHER

Smear layer is partially removed by etchant of phosphoric acid

Drug: Olinanoseal; Drug: Curodont D'senz

Interventions

Olinanoseal DRUG

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.

Also known as: silicone polymer protector varnish

Partially removed smear layer; Totally removed smear layer

Curodont D'senz DRUG

This agent contains p 11-4 peptide in addition to fluoride

Also known as: Self assembling peptide containing desensitizing agent

Partially removed smear layer; Totally removed smear layer

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Presence of a minimum of four hypersensitive teeth in each patient.
• Patients with teeth recorded a discomfort score of two or more to tactile, cold and air stimulation.
• Teeth having hypersensitivity only on the facial aspect.
• Patients' willingness to participate in the study

You may not qualify if:

• Patients with any medical or dental condition that could impact the study results during its expected length.
• Patients with a history of drug addictions and use of potent analgesic and/ or anti-inflammatory drugs.
• Patients who refused to give their consents.
• Patients with any extensive or unsatisfactory restorations, prosthesis or orthodontic appliances which involve the cervical areas

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Faculty of dental Medicine for girls, Al-AZhar University

Cairo, Egypt

Location

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Asmaa A mosleh, lecturer

  lecturer, faculty of dental medicine, Al-Azhar university

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: they don't know the type of intervention used
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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 Record Dates

• First Submitted: March 17, 2021
• First Posted: November 16, 2021
• Study Start: April 20, 2020
• Primary Completion: November 23, 2020
• Study Completion: January 12, 2021
• Last Updated: November 16, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)