AzTrials
AzTrials

HypersensitivityPhase 2/3NCT04485299

Clinical Assessment of Bifluorid 10 vs Varnish Fluoride on The Exposed Hypersensitive Cervical Dentin in Adult Patient

A Phase 2/3 study testing Bifluorid 10 ,VOCO and Sodium Fluoride 5% Dental Varnish in people with Hypersensitivity and Dentin Sensitivity, run by Cairo University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Aim of the study will be conducted to compare the efficacy of bifluoride (NaF and CaF) versus conventional fluoride varnish (Sodium Flouride) in the management of hypersensitivity of exposed cervical area in adult patients over 2 month Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Hypersensitivity, Dentin Sensitivity
What is being tested?
Bifluorid 10 ,VOCO and Sodium Fluoride 5% Dental Varnish
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
No sites listed yet
Study dates
Oct 2020to Jan 2021
Phase
Phase 2/3
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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy patient with free medical history.
  • Age range 18-60 years old.
  • Good oral hygiene
  • Patients suffering from pain due to dentin hypersensitivity.
  • Patient with sound first molar .

Who cannot join

  • Patients using desensitizing agents, receiving periodontal treatment or had received nonsurgical periodontal treatment in the last three months.
  • Patient wearing orthodontic appliance.
  • Patient with teeth having a painful condition involving the pulp and periapical region.
  • Patients who had allergy to materials will be used in the study.
  • Pregnancy.
  • Patient who does not consent to participation.
  • Patient who does not attend to the follow up.
  • A patient who has a carious first molar.

Trial locations and contacts

No sites are listed yet.

Zaid Yousef Alkhatteb, BSc contact

00201272111897

zaid_yousef@denstistry.cu.edu.eg

About this study

Official title: Quantitative Clinical Assessment of Bifluorid 10 Versus Varnish Fluoride on The Exposed Hypersensitive Cervical Dentin in Adult Patient: A Randomized Clinical Trial

Aim of the study will be conducted to compare the efficacy of bifluoride (NaF and CaF) versus conventional fluoride varnish (Sodium Flouride) in the management of hypersensitivity of exposed cervical area in adult patients over 2 month

Being tested
Bifluorid 10 ,VOCO, Sodium Fluoride 5% Dental Varnish
Medical subject headings
Hypersensitivity, Dentin Sensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bifluorid 10 ,VOCODrug

    Also called Bifluorid 10

    NaF and CaF 10 %

  • Sodium Fluoride 5% Dental VarnishDrug

    Also called conventional sodium fluoride varnish

    5% NaF

Study groups in NCT04485299
Study groupRoleWhat they receive
bifluorid 10 varnishExperimentalBifluorid 10 (NaF and CaF) lead to reduce the dentin hypersensitivity, the sodium fluoride (NaF) dissociates and releases F ions, that diffuse through the tubules and then precipitates as calcium fluoride as a consequence of the high of calcium content in saliva and dentinal fluid ,The calcium fluoride (CaF) present in the varnish composition diffuses into the tubules and block the canal with a semi-permanent protective layer.The calcium fluoride is added to block the dentin tubules mechanically, by the combination with the calcium fluoride resulted from the sodium fluoride reaction to the calcium of dentin.
Receives: Drug: Bifluorid 10 ,VOCO
sodium fluoride varnishActive comparatorTopical application of varnish fluoride (sodium fluoride NaF) effect on exposed dentine as a desensitizing agent, the varnish fluoride process is caused by the reaction between NaF and calcium ions resulting in calcium fluoride crystals being deposited on the openings of the dentinal tubules that decrease pain.
Receives: Drug: Sodium Fluoride 5% Dental Varnish

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dentin hypersensitivity

    measurement of dentin hypersensitivity by VAS scale

    Measured: pre-intervention

  2. Dentin hypersensitivity

    measurement of dentin hypersensitivity by VAS scale

    Measured: 2 min

  3. Dentin hypersensitivity

    measurement of dentin hypersensitivity by VAS scale

    Measured: 1 week

  4. Dentin hypersensitivity

    measurement of dentin hypersensitivity by VAS scale

    Measured: 4 weeks

  5. Dentin hypersensitivity

    measurement of dentin hypersensitivity by VAS scale

    Measured: 8 weeks

Secondary outcomes (2)

  1. Dentinal tubule occlusion

    Percentage of dentinal tubule occlusion measure by scanning electron microscope SEM

    Measured: Pre-intervention

  2. Dentinal tubule occlusion

    Percentage of dentinal tubule occlusion measure by scanning electron microscope SEM

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2020
  2. Study startOct 2020 (estimated)
  3. Primary completionDec 2020 (estimated)
  4. Study completionJan 2021 (estimated)

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04485299
Sponsor's protocol ID
OPR 20/7/2020
Status last verified
Jul 2020
First submitted
19 Jul 2020
Last updated
24 Jul 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Bifluorid 10 ,VOCO and Sodium Fluoride 5% Dental Varnish in people with Hypersensitivity and Dentin Sensitivity, run by Cairo University.

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 5 inclusion and 8 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 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Zaid Yousef Alkhatteb, BSc (00201272111897, zaid_yousef@denstistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dentin hypersensitivity (time frame: pre-intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04485299.

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 Jul 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in