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Dentin HypersensitivityPhase 2/3NCT04819867

Comparison Of The Effect Of Propolis And Gluma Desensitizer On The Management Of Dentin Hypersensitivity

A Phase 2/3 study testing Propolis and Gluma Desensitizer in people with Dentin Hypersensitivity, run by Dow University of Health Sciences at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Objective The purpose of this study was to compare the effect of Propolis and Gluma desensitizer on the management of Dentin Hypersensitivity Methods Patients with dentin hypersensitivity exhibiting pain scores of at least '2' on the visual analog scale (VAS) were included in the study. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Dentin Hypersensitivity
What is being tested?
Propolis and Gluma Desensitizer
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 sitePakistan
Study dates
16 Dec 2018to 31 Dec 2019
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

  • Patients aged 18- 60 years.
  • Patients who have at least one tooth of dentin hypersensitivity on right and left side of the mouth, non carious cervical lesion.
  • Patients exhibiting pain scores of at least two on visual analogue scale would be included in the study

Who cannot join

  • Teeth with fractures or cracks in the cervical areas of the teeth.
  • Cervical areas that are involved in extensive fillings, dentures or orthodontics appliances.
  • Patients who have a history of any psychological diseases.
  • Patients who use analgesic/anti-inflammatory medicines on daily basis.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Marina Shah

    Karachi, Sindh, 75530

Other trials in Pakistan

About this study

Objective The purpose of this study was to compare the effect of Propolis and Gluma desensitizer on the management of Dentin Hypersensitivity Methods Patients with dentin hypersensitivity exhibiting pain scores of at least '2' on the visual analog scale (VAS) were included in the study. Patient's response to an air blast stimulus was noted on Visual Analogue Scale and Schiff's scale in order to record the degree of hypersensitivity of teeth. There were 80 teeth, 40 in each group. The baseline scores were obtained. Propolis and Gluma desensitizer were randomly applied to each hypersensitive tooth. VAS scores and Schiff's sensitivity score for air blast stimulus were then noted at baseline, immediate, after 1 week and then after 1 month of application.

Read the detailed description

INTRODUCTION Dentin hypersensitivity is commonly characterized by a short sharp pain. This pain is believed to arise from the dentinal tubules that are exposed particularly in response to external stimuli such as evaporative, thermal, tactile or chemical forces.Pain caused by dentin hypersensitivity hampers an individual's day to day activities which includes eating, drinking and often breathing. Since patients do not perceive this as a severe problem they usually do not seek professional treatment. They prefer over the counter products to reduce the sensitivity when the severity increases.

Hydrodynamic theory by Astron and Brannstorm is accepted most widely out of several theories. According to him the flow of the dentinal fluid was dependent upon the mechanical, thermal, evaporative, and osmotic stimuli. This flow in tubules can activate nerves along the entire canal of the pulp causing pain. Therefore, closing the dentinal tubules is the key approach in the management of dentin hypersensitivity. This can be done possibly by crystal precipitation in the tubule. Various methods and agents are being used for its management for instance laser therapy and fluorine preparations, strontium and zinc chlorides, potassium oxalate and dental adhesives.

Gluma desensitizer is an aqueous solution which contains glutaraldehyde 5% and hydroxyethyl methacrylate (HEMA) 35%. It has been found to be an effective desensitizing agent. It blocks the dentinal tubules intrinsically, countering the mechanism of hydrodynamics that eventually leads to dentin hypersensitivity.

Propolis is a naturally occurring resin. It is brown in colour. It is collected by honey bees from exudates of plants and trees. With the secretions and wax it is modified in the beehives. Honey bees use it to protect their hives and repair any opening or damage.

In homeopathic practices it is widely used as an anti-inflammatory and antiseptic agent. Propolis is composed of resins 50-60%, waxes 30-40%, essential oils 5-10%, pollen 5% and other micro elements like aluminium and calcium.

In dentistry, propolis is found to have multiple clinical uses. It can be used as a mouth freshener in halitosis, as a mouthwash, a relief from denture stomatitis, to heal ulcerations, cervical, dentinal, and root caries sensitivity.

Several studies that were performed in vitro have revealed that, propolis has a significant effect on the reduction of dentin permeability. Studies comparing the desensitizing effect of propolis with gluma desensitizer in-vivo are found to be very few.

MATERIALS AND METHODS Study design and settings A randomized, single blind clinical trial was conducted in the department of Operative dentistry, Dr. Ishrat ul Ebad Khan Institute of Oral Health Sciences, Karachi.

Selection criteria

Patient inclusion criteria:

  • Patients aged 18- 60 years.
  • Patients who had at least two teeth with dentin hypersensitivity, non carious cervical lesion.
  • Patients exhibiting pain scores of ≥ 2 on visual analogue scale.

Patient exclusion criteria:

  • Teeth with fractures or cracks in the cervical areas of the teeth.
  • Cervical areas that are involved in extensive fillings, dentures or orthodontics appliances.
  • Patients having any psychological disease.
  • Patients taking analgesics on daily basis.

Withdrawal criteria Failure to complete follow-up after undergoing initial treatment and giving consent.

Method of collection of data Ethical approval Approval was granted by the Institutional review board of Dow University of Health Sciences.

Informed consent All the study participants were informed in detail about the nature of the research procedure, and a written consent was obtained.

Sample size and technique The sample size calculated was 80 teeth, 40 teeth per group (Group A = Propolis, group B = Gluma) carried out using PASS v.11 to independent sample T test at 95% confidence interval and 80% power of test. Calculation was done on mean SD values 0.6+/-0.58 and 0.31+/-0.459 of propolis and gluma respectively.

The sampling technique used in this study was non probability purposive sampling.

Study duration The experimental period of this study was one month. The desensitizing agents were randomly applied to the dentin hypersensitive teeth.

Application procedure:

  • First the affected area was cleaned of any debris or plaque.
  • Isolation of the affected tooth was done with the help of cotton rolls.
  • Tooth surfaces was dried with cotton pellet.
  • 30% ethanolic extract of propolis was applied on the dentin hypersensitive site by using a bonding brush then was allowed to dry for 60 seconds.
  • Gluma desensitizer was applied according to the manufacturer's instructions.
  • Care was taken that the desensitizing agents do not touch any other surface of the oral mucosa.
  • Instructions were then given to the patient to not to rinse, eat or drink for 30 minutes after the application of the desensitizing agent.
  • Further the patient was asked to avoid the usage of any other desensitizing agent during this one month study period.

The evaporative (air blast) sensitivity test was assessed by application of air from a triple air dental syringe for 1-2 second at a distance of 1 cm from the isolated tooth surface, to avoid desiccation of the dentin surface.

Schiff's sensitivity scale, and visual analogue scale were used to assess dentine hypersensitivity on air blast stimuli at baseline, immediate, after one week of application and after one month of application of the desensitizing agent.

Being tested
Propolis, Gluma Desensitizer
Medical subject headings
Dentin Sensitivity

What participants receive

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

  • PropolisDrug

    propolis is an extract derived from bee hives

  • Gluma DesensitizerDrug

    Also called gluma

    Gluma is a desensitizer agent

Study groups in NCT04819867
Study groupRoleWhat they receive
propolisExperimentalpropolis will be applied to the affected teeth
Receives: Drug: Propolis
gluma desensitizerActive comparatorGluma desensitizer will be applied to the affected teeth
Receives: Drug: Gluma Desensitizer

What is being measured

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

  1. treatment of dentin hypersensitivity

    management of dentin hypersensitivity

    Measured: baseline reading will be taken on VAS At day 0 then propolis will be applied.

  2. treatment of dentin hypersensitivity

    management of dentin hypersensitivity

    Measured: reading on VAS will be taken immediately after application of Propolis on day 0

  3. treatment of dentin hypersensitivity

    management of dentin hypersensitivity

    Measured: reading on VAS will be taken after 1 week of application Propolis

  4. treatment of dentin hypersensitivity

    management of dentin hypersensitivity

    Measured: reading on VAS will be taken after 1 month of application of Propolis

  5. treatment of dentin hypersensitivity

    management of dentin hypersensitivity

    Measured: baseline reading will be recorded on Schiff sensitivity score on day 0, then Propolis will be applied

  6. treatment of dentin hypersensitivity

    management of dentin hypersensitivity

    Measured: reading will be recorded on Schiff sensitivity score on day 0, immediately after application of Propolis

  7. treatment of dentin hypersensitivity

    management of dentin hypersensitivity

    Measured: reading will be recorded on Schiff sensitivity score 1 week after application of Propolis

  8. treatment of dentin hypersensitivity

    management of dentin hypersensitivity

    Measured: reading will be recorded on Schiff sensitivity score 1 month after application of Propolis

  9. treatment of dentin hypersensitivity

    management of dentin hypersensitivity

    Measured: baseline reading will be taken on VAS at day 0, before application of Gluma desensitizer

  10. treatment of dentin hypersensitivity

    management of dentin hypersensitivity

    Measured: reading will be taken on VAS at day 0, immediately after application of Gluma desensitizer

  11. treatment of dentin hypersensitivity

    management of dentin hypersensitivity

    Measured: reading will be taken on VAS 1 week after application of Gluma desensitizer

  12. treatment of dentin hypersensitivity

    management of dentin hypersensitivity

    Measured: reading will be taken on VAS 1 month after application of Gluma desensitizer

  13. treatment of dentin hypersensitivity

    management of dentin hypersensitivity

    Measured: baseline reading will be recorded on Schiff sensitivity score on day 0, then Gluma desensitizer will be applied

  14. treatment of dentin hypersensitivity

    management of dentin hypersensitivity

    Measured: reading will be recorded on Schiff sensitivity score on day 0, immediately after application of Gluma desensitizer

  15. treatment of dentin hypersensitivity

    management of dentin hypersensitivity

    Measured: reading will be recorded on Schiff sensitivity score 1 week after application of Gluma desensitizer

  16. treatment of dentin hypersensitivity

    management of dentin hypersensitivity

    Measured: reading will be recorded on Schiff sensitivity score 1 month after application of Gluma desensitizer

Timeline

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

  1. First posted29 Mar 2021
  2. Study start16 Dec 2018
  3. Primary completion30 Mar 2019
  4. Study completion31 Dec 2019

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
Participant
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04819867
Sponsor's protocol ID
MShah
Status last verified
Mar 2021
First submitted
12 Mar 2021
Last updated
29 Mar 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shah M, Jat SA, Aziz M. Comparison of the effect of propolis and Gluma desensitizer on the management of dentin hypersensitivity: A randomized controlled trial. J Pak Med Assoc. 2024 May;74(5):843-847. doi: 10.47391/JPMA.9924.

    PubMed 38783427

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Propolis and Gluma Desensitizer in people with Dentin Hypersensitivity, run by Dow University of Health Sciences at 1 site in Pakistan.

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 3 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 29 Mar 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 Pakistan. 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 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?

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?

treatment of dentin hypersensitivity (time frame: baseline reading will be taken on VAS At day 0 then propolis will be applied.). The study lists 16 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 NCT04819867, which also lists 1 linked publication.

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 29 Mar 2021.

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