Dentin HypersensitivityPhase 4NCT05122312
Comparative Study on the Efficacy of OliNano SEAL and Curodont D' Senz in Treatment of Dentin Hypersensitivity
A Phase 4 study testing Olinanoseal and Curodont D'senz in people with Dentin Hypersensitivity, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This study was conducted to evaluate and compare the efficacy of Olinanoseal and Curodont D'Senz in treatment of dentin hypersensitivity. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Dentin Hypersensitivity
- What is being tested?
- Olinanoseal and Curodont D'senz
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2020to 12 Jan 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This study was conducted to evaluate and compare the efficacy of Olinanoseal and Curodont D'Senz in treatment of dentin hypersensitivity.
Read the 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).
- Conditions
- Dentin Hypersensitivity
- Being tested
- Olinanoseal, Curodont D'senz
- Keywords
- OLiNano SEAL, Curodont D'Senz, Dentin Hypersensitivity, Dye penetration, Dentin permeability
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlinanosealDrug
Also called silicone polymer protector varnish
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'senzDrug
Also called Self assembling peptide containing desensitizing agent
This agent contains p 11-4 peptide in addition to fluoride
| Study group | Role | What they receive |
|---|---|---|
| Totally removed smear layer | Other | Smear layer is completely removed by etchant of phosphoric acid Receives: Drug: Olinanoseal; Drug: Curodont D'senz |
| Partially removed smear layer | Other | Smear layer is partially removed by etchant of phosphoric acid Receives: Drug: Olinanoseal; Drug: Curodont D'senz |
What is being measured
The primary outcome is the main question the study is designed to answer.
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}])
Measured: 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}])
Measured: 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}])
Measured: 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}])
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start20 Apr 2020
- Primary completion23 Nov 2020
- Study completion12 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentin HypersensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Ahmed Mosleh, Al-Azhar University
- Investigators
- Asmaa A mosleh, lecturer, Study chair, lecturer, faculty of dental medicine, Al-Azhar university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122312
- Sponsor's protocol ID
- OPDENT A13
- Status last verified
- Nov 2021
- First submitted
- 17 Mar 2021
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study on the Efficacy of OliNano SEAL and Curodont D' Senz in Treatment of Dentin Hypersensitivity
- ClinicalTrials.gov ID
- NCT05122312
- Acronym / sponsor ID
- OPDENT A13
- Conditions
- Dentin Hypersensitivity
- Keywords
- OLiNano SEAL, Curodont D'Senz, Dentin Hypersensitivity, Dye penetration, Dentin permeability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 23 Nov 2020 (actual)
- Study completion
- 12 Jan 2021 (actual)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Totally removed smear layer | Other | Drug: Olinanoseal, Drug: Curodont D'senzSmear layer is completely removed by etchant of phosphoric acid |
| Partially removed smear layer | Other | Drug: Olinanoseal, Drug: Curodont D'senzSmear layer is partially removed by etchant of phosphoric acid |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlinanosealAlso: silicone polymer protector varnishit 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. | Drug | Partially removed smear layer, Totally removed smear layer |
| Curodont D'senzAlso: Self assembling peptide containing desensitizing agentThis agent contains p 11-4 peptide in addition to fluoride | Drug | Partially removed smear layer, Totally removed smear layer |
Primary outcome
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}])
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}])
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}])
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}])
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asmaa A mosleh, lecturer study chair
lecturer, faculty of dental medicine, Al-Azhar university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Olinanoseal and Curodont D'senz in people with Dentin Hypersensitivity, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dentin hypersensitivity (time frame: 2 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.