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

Primary Purpose

Dentin Hypersensitivity

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Olinanoseal
Curodont D'senz
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentin Hypersensitivity focused on measuring OLiNano SEAL, Curodont D'Senz, Dentin Hypersensitivity, Dye penetration, Dentin permeability

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of dental Medicine for girls, Al-AZhar University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Totally removed smear layer

Partially removed smear layer

Arm Description

Smear layer is completely removed by etchant of phosphoric acid

Smear layer is partially removed by etchant of phosphoric acid

Outcomes

Primary Outcome Measures

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}])
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}])
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}])
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}])

Secondary Outcome Measures

Full Information

First Posted
March 17, 2021
Last Updated
November 14, 2021
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT05122312
Brief Title
Comparative Study on the Efficacy of OliNano SEAL and Curodont D' Senz in Treatment of Dentin Hypersensitivity
Official Title
Comparative Study on the Efficacy of OliNano SEAL and Curodont D' Senz in Treatment of Dentin Hypersensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
April 20, 2020 (Actual)
Primary Completion Date
November 23, 2020 (Actual)
Study Completion Date
January 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Hypersensitivity
Keywords
OLiNano SEAL, Curodont D'Senz, Dentin Hypersensitivity, Dye penetration, Dentin permeability

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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).
Masking
ParticipantCare Provider
Masking Description
they don't know the type of intervention used
Allocation
Non-Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Totally removed smear layer
Arm Type
Other
Arm Description
Smear layer is completely removed by etchant of phosphoric acid
Arm Title
Partially removed smear layer
Arm Type
Other
Arm Description
Smear layer is partially removed by etchant of phosphoric acid
Intervention Type
Drug
Intervention Name(s)
Olinanoseal
Other Intervention Name(s)
silicone polymer protector varnish
Intervention Description
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
Intervention Name(s)
Curodont D'senz
Other Intervention Name(s)
Self assembling peptide containing desensitizing agent
Intervention Description
This agent contains p 11-4 peptide in addition to fluoride
Primary Outcome Measure Information:
Title
dentin hypersensitivity
Description
pain score (visual analogue scale VAS ["minmum =0 {best}, maximum=10 {worst}] and verbal rating scale VRS ["minmum =0 {best}, maximum=4 {worst}])
Time Frame
2 minutes
Title
dentin hypersensitivity
Description
pain score (visual analogue scale VAS ["minmum =0 {best}, maximum=10 {worst}] and verbal rating scale VRS ["minmum =0 {best}, maximum=4 {worst}])
Time Frame
2 weeks
Title
dentin hypersensitivity
Description
pain score (visual analogue scale VAS ["minmum =0 {best}, maximum=10 {worst}]) and verbal rating scale VRS ["minmum =0 {best}, maximum=4 {worst}])
Time Frame
4 weeks
Title
dentin hypersensitivity
Description
pain score (visual analogue scale VAS ["minmum =0 {best}, maximum=10 {worst}] and verbal rating scale VRS ["minmum =0 {best}, maximum=4 {worst}])
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asmaa A mosleh, lecturer
Organizational Affiliation
lecturer, faculty of dental medicine, Al-Azhar university
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of dental Medicine for girls, Al-AZhar University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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