Clinical trial NCT04754763: A Comparative Study On The Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
Official title: A Comparative Study On The Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Dentine Hypersensitivity
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background:

Dentine hypersensitivity (DH) causes considerable pain and discomfort to an individual due to number of stimuli on exposed dentine. Different kinds of treatment strategies are used in the resolution of dentine hypersensitivity including the use of propolis and dentine bonding agent. No study had compared the efficacy of propolis and dentine bonding agent.

Objective:

The objective of the study was to find out whether there is a difference in the efficacy of Propolis and seventh generation dentine bonding agent in reducing the dentine hypersensitivity. Comparison within the groups and pairwise comparisons were also recorded in reducing dentine hypersensitivity.

Methods:

In this six month In- Vivo single blinded randomized clinical study, a total number of 52 patients with complain of dentine hypersensitivity were selected in two groups after taking informed consent. Group A and B received 30% ethanolic extract of propolis and dentine bonding agents respectively by a trained operator. Recordings of dentine hypersensitivity were obtained at Day 0, before and after the application of experimental agents, and also on Day 7, 15 and 30 by the principal investigator. Response was measured by Visual Analog Scale and Schiff Cold Air Sensitivity Scale. Statistical Package for the Social Sciences (SPSS) version 20 was used to analyze the data with level of significance set at p \< 0.05. Friedman test was applied to see the comparison within groups and Wilcoxon Signed Rank test was used for Pairwise comparison. Mann Whitney U-Test was applied for comparison between groups.


Eligibility criteria: Inclusion Criteria:

* Outpatients reporting to Periodontology department of Dow International Dental College (DIDC) with dentine hypersensitivity
* Patients having age of 20- 45 years
* Systemically healthy patients
* Patients having at least 2 vital teeth with hypersensitivity
* Patients having sensitivity on facial surfaces to air stimulus
* Patients with Score I of Silness and Loe Plaque Index 77
* Patients who used Fluoride dentifrices for hypersensitivity but could not get relief from it.

Exclusion Criteria:

* Patients with carious, cracked or restored teeth, abutment teeth used of removable or fixed prosthesis and tooth with any other dental pathology
* Patients who used analgesics, mood alteration drugs during last six months
* Smoker, pregnant and nursing mothers
* Patients who used tooth whitening or bleaching agents in the last six months
* Patients who were undergoing orthodontic therapy and history of periodontal surgery during last six months

Primary outcomes:
measure: Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
timeFrame: Before application of experimental agents (Day 0)
measure: Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
timeFrame: Before application of experimental agents (Day 0)
measure: Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
timeFrame: 1 minute after application of experimental agents (Day 0)
measure: Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
timeFrame: 1 minute after application of experimental agents (Day 0)
measure: Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
timeFrame: Day 7
measure: Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
timeFrame: Day 7
measure: Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
timeFrame: Day 15
measure: Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
timeFrame: Day 15
measure: Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
timeFrame: Day 30
measure: Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
timeFrame: Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dow International Dental Campus (Defence Campus)
state: Sindh
Study officials:
affiliation: Dow University of Health Sciences
name: Ather Akber, M.Sc
role: PRINCIPAL_INVESTIGATOR
References: