HypersensitivityPhase 1NCT04472182
Efficacy of Fluoride Varnish Containing Xylitol Coated Calcium Phosphate Versus Conventional Fluoride Varnish in Management of Hypersensitivity of Exposed Root Surfaces in Adult Patients
A Phase 1 study testing Fluoride varnish with xylitol coated calcium and phosphate in people with Hypersensitivity, run by Cairo University at 1 site in Egypt.
Trial summary
This clinical trial will be conducted to compare the efficacy of fluoride varnish containing xylitol coated calcium and phosphate or potassium nitrate gel versus conventional fluoride varnish in the management of hypersensitivity of non-carious exposed root surfaces in adult patients over a 12 months period. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypersensitivity
- What is being tested?
- Fluoride varnish with xylitol coated calcium and phosphate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2020to 21 Dec 2021
- Phase
- Phase 1
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or females. Age: 20-50 years old. Patients having at least one tooth with exposed root surface Teeth with hypersensitivity, VAS ≥5 Patients with good oral hygiene. Co-operative patients who show interest to participate in the study
Who cannot join
- Patients with bad oral hygiene Patients with orthodontic appliances, or bridge work that might interfere with evaluation Patients who are allergic to any ingredients will be used in the study. Carious teeth Mobile teeth. (Grade 2 or Grade 3) Teeth with hypersensitivity, VAS <5 Patients with physical disabilities Pregnant or lactating women Other dental defects that causes pain. Allergy from any used materials or any allergic reaction during our clinical trial (The trial will be stopped at once and all the needed management against any allergic reaction will be done.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Fluoride Varnish Containing Xylitol Coated Calcium Phosphate Versus Conventional Fluoride Varnish in Management of Hypersensitivity of Exposed Root Surfaces in Adult Patients: A Randomized Clinical Trial
This clinical trial will be conducted to compare the efficacy of fluoride varnish containing xylitol coated calcium and phosphate or potassium nitrate gel versus conventional fluoride varnish in the management of hypersensitivity of non-carious exposed root surfaces in adult patients over a 12 months period.
- Conditions
- Hypersensitivity
- Being tested
- Fluoride varnish with xylitol coated calcium and phosphate
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoride varnish with xylitol coated calcium and phosphateDrug
Fluoride varnish with xylitol coated calcium and phosphate
| Study group | Role | What they receive |
|---|---|---|
| Fluoride varnish with xylitol coated calcium and phosphate | Experimental | Not described Receives: Drug: Fluoride varnish with xylitol coated calcium and phosphate |
| Conventional Fluoride varnish | Active comparator | Not described Receives: Drug: Fluoride varnish with xylitol coated calcium and phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain due to Dentin Hypersensitivity
Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale
Measured: Two minutes before intervention
Pain due to Dentin Hypersensitivity
Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale
Measured: 4 hours
Pain due to Dentin Hypersensitivity
Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale
Measured: 2 days
Pain due to Dentin Hypersensitivity
Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale
Measured: 4 months
Pain due to Dentin Hypersensitivity
Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale
Measured: 8 months
Pain due to Dentin Hypersensitivity
Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale
Measured: 12 months
Secondary outcomes (12)
Measuring Salivary pH
measuring Unstimulated Salivary pH using pH meter from 0-14
Measured: Two minutes before intervention
Measuring Salivary pH
measuring Unstimulated Salivary pH using pH meter from 0-14
Measured: 4 hours
Measuring Salivary pH
measuring Unstimulated Salivary pH using pH meter from 0-14
Measured: 2 days
Measuring Salivary pH
measuring Unstimulated Salivary pH using pH meter from 0-14
Measured: 4 months
Measuring Salivary pH
measuring Unstimulated Salivary pH using pH meter from 0-14
Measured: 8 months
Measuring Salivary pH
measuring Unstimulated Salivary pH using pH meter from 0-14
Measured: 12 months
Image analysis to assess amount of plaque adherence
Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface
Measured: 2 minutes before intervention
Image analysis to assess amount of plaque adherence
Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface
Measured: 4 hours
Image analysis to assess amount of plaque adherence
Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface
Measured: 2 days
Image analysis to assess amount of plaque adherence
Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface
Measured: 4 months
Image analysis to assess amount of plaque adherence
Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface
Measured: 8 months
Image analysis to assess amount of plaque adherence
Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start20 Dec 2020
- Primary completion21 Dec 2021
- Study completion21 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Dentin Hypersensitivity
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Edward Ibrahim Abdelmalik, Cairo University
- Investigators
- Peter E Abdelmalik, Master, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472182
- Sponsor's protocol ID
- CairoUniv
- Status last verified
- Jan 2022
- First submitted
- 11 Jul 2020
- Last updated
- 24 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Fluoride Varnish Containing Xylitol Coated Calcium Phosphate Versus Conventional Fluoride Varnish in Management of Hypersensitivity of Exposed Root Surfaces in Adult Patients: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04472182
- Acronym / sponsor ID
- CairoUniv
- Conditions
- Hypersensitivity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Dec 2020 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 21 Dec 2021 (actual)
- First posted
- 15 Jul 2020 (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 clinical trial will be conducted to compare the efficacy of fluoride varnish containing xylitol coated calcium and phosphate or potassium nitrate gel versus conventional fluoride varnish in the management of hypersensitivity of non-carious exposed root surfaces in adult patients over a 12 months period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Dentin Hypersensitivity
| Arm | Type | Receives |
|---|---|---|
| Fluoride varnish with xylitol coated calcium and phosphate | Experimental | Drug: Fluoride varnish with xylitol coated calcium and phosphate |
| Conventional Fluoride varnish | Active comparator | Drug: Fluoride varnish with xylitol coated calcium and phosphate |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Males or females. Age: 20-50 years old. Patients having at least one tooth with exposed root surface Teeth with hypersensitivity, VAS ≥5 Patients with good oral hygiene. Co-operative patients who show interest to participate in the study
Key exclusion criteria (1 listed)
- Patients with bad oral hygiene Patients with orthodontic appliances, or bridge work that might interfere with evaluation Patients who are allergic to any ingredients will be used in the study. Carious teeth Mobile teeth. (Grade 2 or Grade 3) Teeth with hypersensitivity, VAS <5 Patients with physical disabilities Pregnant or lactating women Other dental defects that causes pain. Allergy from any used materials or any allergic reaction during our clinical trial (The trial will be stopped at once and all the needed management against any allergic reaction will be done.)
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 |
|---|---|---|
| Fluoride varnish with xylitol coated calcium and phosphateFluoride varnish with xylitol coated calcium and phosphate | Drug | Conventional Fluoride varnish, Fluoride varnish with xylitol coated calcium and phosphate |
Primary outcome
Pain due to Dentin Hypersensitivity
Time frame: Two minutes before intervention
Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale
Pain due to Dentin Hypersensitivity
Time frame: 4 hours
Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale
Pain due to Dentin Hypersensitivity
Time frame: 2 days
Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale
Pain due to Dentin Hypersensitivity
Time frame: 4 months
Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale
Pain due to Dentin Hypersensitivity
Time frame: 8 months
Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale
Pain due to Dentin Hypersensitivity
Time frame: 12 months
Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale
12 secondary outcomes
Measuring Salivary pH
Time frame: Two minutes before intervention
Measuring Salivary pH
Time frame: 4 hours
Measuring Salivary pH
Time frame: 2 days
Measuring Salivary pH
Time frame: 4 months
Measuring Salivary pH
Time frame: 8 months
Measuring Salivary pH
Time frame: 12 months
Image analysis to assess amount of plaque adherence
Time frame: 2 minutes before intervention
Image analysis to assess amount of plaque adherence
Time frame: 4 hours
Image analysis to assess amount of plaque adherence
Time frame: 2 days
Image analysis to assess amount of plaque adherence
Time frame: 4 months
Image analysis to assess amount of plaque adherence
Time frame: 8 months
Image analysis to assess amount of plaque adherence
Time frame: 12 months
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 24 Jan 2022.
- Individual participant dataSharing planned: Undecided
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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.
Peter E Abdelmalik, Master principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fluoride varnish with xylitol coated calcium and phosphate in people with 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 1 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 24 Jan 2022. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Pain due to Dentin Hypersensitivity (time frame: Two minutes before intervention). The study lists 6 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 24 Jan 2022.