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

NCT ID: NCT05122312

Last Updated: 2021-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-20

Study Completion Date

2021-01-12

Brief Summary

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

Detailed Description

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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).

Conditions

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Dentin Hypersensitivity

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
they don't know the type of intervention used

Study Groups

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Totally removed smear layer

Smear layer is completely removed by etchant of phosphoric acid

Group Type OTHER

Olinanoseal

Intervention Type 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.

Curodont D'senz

Intervention Type DRUG

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

Partially removed smear layer

Smear layer is partially removed by etchant of phosphoric acid

Group Type OTHER

Olinanoseal

Intervention Type 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.

Curodont D'senz

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Curodont D'senz

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

Intervention Type DRUG

Other Intervention Names

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silicone polymer protector varnish Self assembling peptide containing desensitizing agent

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Asmaa Ahmed Mosleh

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Asmaa A mosleh, lecturer

Role: STUDY_CHAIR

lecturer, faculty of dental medicine, Al-Azhar university

Locations

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Faculty of dental Medicine for girls, Al-AZhar University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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OPDENT A13

Identifier Type: -

Identifier Source: org_study_id