NCT04819867

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 16, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed
Last Updated

March 29, 2021

Status Verified

March 1, 2021

Enrollment Period

3 months

First QC Date

March 12, 2021

Last Update Submit

March 25, 2021

Conditions

Dentin Hypersensitivity

Outcome Measures

Primary Outcomes (16)

  • treatment of dentin hypersensitivity

    management of dentin hypersensitivity

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

  • treatment of dentin hypersensitivity

    management of dentin hypersensitivity

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

  • treatment of dentin hypersensitivity

    management of dentin hypersensitivity

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

  • treatment of dentin hypersensitivity

    management of dentin hypersensitivity

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

  • treatment of dentin hypersensitivity

    management of dentin hypersensitivity

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

  • treatment of dentin hypersensitivity

    management of dentin hypersensitivity

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

  • treatment of dentin hypersensitivity

    management of dentin hypersensitivity

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

  • treatment of dentin hypersensitivity

    management of dentin hypersensitivity

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

  • treatment of dentin hypersensitivity

    management of dentin hypersensitivity

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

  • treatment of dentin hypersensitivity

    management of dentin hypersensitivity

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

  • treatment of dentin hypersensitivity

    management of dentin hypersensitivity

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

  • treatment of dentin hypersensitivity

    management of dentin hypersensitivity

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

  • treatment of dentin hypersensitivity

    management of dentin hypersensitivity

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

  • treatment of dentin hypersensitivity

    management of dentin hypersensitivity

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

  • treatment of dentin hypersensitivity

    management of dentin hypersensitivity

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

  • treatment of dentin hypersensitivity

    management of dentin hypersensitivity

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

Study Arms (2)

propolis

EXPERIMENTAL

propolis will be applied to the affected teeth

Drug: Propolis

gluma desensitizer

ACTIVE COMPARATOR

Gluma desensitizer will be applied to the affected teeth

Drug: Gluma Desensitizer

Interventions

PropolisDRUG

propolis is an extract derived from bee hives

propolis
Gluma DesensitizerDRUG

Gluma is a desensitizer agent

Also known as: gluma
gluma desensitizer

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marina Shah

Karachi, Sindh, 75530, Pakistan

Location

Related Publications (1)

  • 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.

    PMID: 38783427DERIVED

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Propolisgluma desensitizerGluma

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Resins, PlantBiopolymersPolymersMacromolecular SubstancesPlant ExudatesBiological ProductsComplex Mixtures

Study Officials

  • Marina Shah, BDS

    DUHS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 12, 2021

First Posted

March 29, 2021

Study Start

December 16, 2018

Primary Completion

March 30, 2019

Study Completion

December 31, 2019

Last Updated

March 29, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)