Dentin HypersensitivityNCT06154941
Clinical Evaluation of Giomer Based Varnish Versus CPP-ACP Varnish in the Management of Dentin Hypersensitivity: a Randomized Clinical Trial
A study testing Giomer Varnish and CPP-ACP varnish in people with Dentin Hypersensitivity, run by Cairo University at 1 site in Egypt.
Trial summary
Dentin hypersensitivity is a drastic problem, which threaten many dental patients. According to the last published systematic review and meta analysis at 2019, the prevalence of dentin hypersensitivity is being 33.5% among the population. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Hypersensitivity
- What is being tested?
- Giomer Varnish and CPP-ACP varnish
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to Aug 2024
- Phase
- Interventional
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants of both genders aged 18 to 40 years with good oral hygiene, suffering from pain due to dentin hypersensitivity in at least one tooth
Who cannot join
- Taking desensitizing treatment in the last 6 months. (It affects the outcome)
- Taking anti-inflammatory drugs. (It affects the hypersensitivity perception)
- Pregnant females. ( They complain from nausea and repeated vomiting attacks)
- Smokers. (Smoking will affect the oral hygiene and periodontal health)
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry
Cairo
yomna khallaf, master, 00201006781076, yomna.sayed@dentistry.cu.edu.eg
About this study
Dentin hypersensitivity is a drastic problem, which threaten many dental patients. According to the last published systematic review and meta analysis at 2019, the prevalence of dentin hypersensitivity is being 33.5% among the population. Moreover, it was determined that young adults with age range from 18 to 44 years exhibited high percentage (43.9%) of such problem
Read the detailed description
Several approaches to dentin hypersensitivity treatment were proposed to interfere, whether transiently or permanently, with the hydrodynamic theory. These approaches include root coverage and the use of lasers, ions, dentinal sealants, and occluding and nerve depolarization agents, chosen according to the primary cause. There are two major strategies in managing DH; the first is nerve desensitization, and the second is the physical occlusion of the patent tubule. The second approach can be carried out through a wide range of treatment modalities, including the use of proteins, salts or ions to plug the tubules. Many agents introduced are capable of sealing dentinal tubules, and can be used to reduce sensitivity. Of these agents are CPP-ACP varnish and the newly introduced giomer based varnish wilth S-PRG technology
- Conditions
- Dentin Hypersensitivity
- Being tested
- Giomer Varnish, CPP-ACP varnish
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Giomer VarnishProcedure or surgery
A light-cured Giomer varnish for prolonged hypersensitivity relief. Seals and protects exposed dentinal tubules to prevent pain. Ideal for patients experiencing loss of enamel, gingival recession
CPP-ACP varnishProcedure or surgery
CPP binds to oral surfaces such as teeth, dentin, oral mucosa and biofilm. CPP-ACP Varnish delivers bioavailable calcium and phosphate ions to occlude dentinal tubules treating dentin hypersensitivity
| Study group | Role | What they receive |
|---|---|---|
| Giomer based Varnish | Experimental | Not described Receives: Procedure: Giomer Varnish |
| CPP-ACP based varnish | Active comparator | Not described Receives: Procedure: CPP-ACP varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaporative test
using an air blast from a conventional dental unit air-water syringe for 5 seconds.
Measured: Immediately postoperative, after 1,3 and 6 months
Thermal Test
using anaesthetic carpule kept in the refrigerator at 4oC for at least 24 hours till it became ice then it is removed from refrigerator immediately before testing .
Measured: Immediately postoperative, after 1,3 and 6 months
Tactile test
using the tip of a sharp explorer (number 3) to gently scratch the exposed cervical surface in an apico-coronal direction with short strokes.
Measured: Immediately postoperative, after 1,3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start1 Sep 2023
- Primary completionJun 2024 (estimated)
- Study completionAug 2024 (estimated)
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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yomna sayed khallaf, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154941
- Sponsor's protocol ID
- Giomer-CPPACP-Varnish
- Status last verified
- Nov 2023
- First submitted
- 24 Nov 2023
- Last updated
- 4 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Giomer Based Varnish Versus CPP-ACP Varnish in the Management of Dentin Hypersensitivity: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06154941
- Acronym / sponsor ID
- Giomer-CPPACP-Varnish
- Conditions
- Dentin Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 4 Dec 2023 (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.
Dentin hypersensitivity is a drastic problem, which threaten many dental patients. According to the last published systematic review and meta analysis at 2019, the prevalence of dentin hypersensitivity is being 33.5% among the population. Moreover, it was determined that young adults with age range from 18 to 44 years exhibited high percentage (43.9%) of such problem
Detailed description
Several approaches to dentin hypersensitivity treatment were proposed to interfere, whether transiently or permanently, with the hydrodynamic theory. These approaches include root coverage and the use of lasers, ions, dentinal sealants, and occluding and nerve depolarization agents, chosen according to the primary cause. There are two major strategies in managing DH; the first is nerve desensitization, and the second is the physical occlusion of the patent tubule. The second approach can be carried out through a wide range of treatment modalities, including the use of proteins, salts or ions to plug the tubules. Many agents introduced are capable of sealing dentinal tubules, and can be used to reduce sensitivity. Of these agents are CPP-ACP varnish and the newly introduced giomer based varnish wilth S-PRG technology
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Giomer based Varnish | Experimental | Procedure: Giomer Varnish |
| CPP-ACP based varnish | Active comparator | Procedure: CPP-ACP varnish |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants of both genders aged 18 to 40 years with good oral hygiene, suffering from pain due to dentin hypersensitivity in at least one tooth
Key exclusion criteria (4 listed)
- Taking desensitizing treatment in the last 6 months. (It affects the outcome)
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 |
|---|---|---|
| Giomer VarnishA light-cured Giomer varnish for prolonged hypersensitivity relief. Seals and protects exposed dentinal tubules to prevent pain. Ideal for patients experiencing loss of enamel, gingival recession | Procedure or surgery | Giomer based Varnish |
| CPP-ACP varnishCPP binds to oral surfaces such as teeth, dentin, oral mucosa and biofilm. CPP-ACP Varnish delivers bioavailable calcium and phosphate ions to occlude dentinal tubules treating dentin hypersensitivity | Procedure or surgery | CPP-ACP based varnish |
Primary outcome
evaporative test
Time frame: Immediately postoperative, after 1,3 and 6 months
using an air blast from a conventional dental unit air-water syringe for 5 seconds.
Thermal Test
Time frame: Immediately postoperative, after 1,3 and 6 months
using anaesthetic carpule kept in the refrigerator at 4oC for at least 24 hours till it became ice then it is removed from refrigerator immediately before testing .
Tactile test
Time frame: Immediately postoperative, after 1,3 and 6 months
using the tip of a sharp explorer (number 3) to gently scratch the exposed cervical surface in an apico-coronal direction with short strokes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Giomer Varnish and CPP-ACP varnish in people with Dentin Hypersensitivity, run by Cairo 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 1 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: status not confirmed, as of the sponsor's last update on 4 Dec 2023. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Faculty of Dentistry Cairo university (010 02159535, dentmail@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaporative test (time frame: Immediately postoperative, after 1,3 and 6 months). The study lists 3 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 4 Dec 2023.