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
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
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
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
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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