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Completed

NCT Number: NCT05122312

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.

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Key information

Conditions

Dentin Hypersensitivity Dentin Sensitivity Stomatognathic Diseases Tooth Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of dental Medicine for girls, Al-AZhar University

Cairo, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: silicone polymer protector varnish

Curodont D'senz

Drug

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

Other names: Self assembling peptide containing desensitizing agent

Primary outcomes

  1. dentin hypersensitivity

    Time frame: 2 minutes

    pain score (visual analogue scale VAS ["minmum =0 {best}, maximum=10 {worst}] and verbal rating scale VRS ["minmum =0 {best}, maximum=4 {worst}])

  2. dentin hypersensitivity

    Time frame: 2 weeks

    pain score (visual analogue scale VAS ["minmum =0 {best}, maximum=10 {worst}] and verbal rating scale VRS ["minmum =0 {best}, maximum=4 {worst}])

  3. dentin hypersensitivity

    Time frame: 4 weeks

    pain score (visual analogue scale VAS ["minmum =0 {best}, maximum=10 {worst}]) and verbal rating scale VRS ["minmum =0 {best}, maximum=4 {worst}])

  4. dentin hypersensitivity

    Time frame: 3 months

    pain score (visual analogue scale VAS ["minmum =0 {best}, maximum=10 {worst}] and verbal rating scale VRS ["minmum =0 {best}, maximum=4 {worst}])

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Nov 16, 2021
Registry last updated
Nov 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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