A Comparative Study On The Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity

NCT ID: NCT04754763

Last Updated: 2021-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-07-30

Brief Summary

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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.

Detailed Description

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Conditions

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Dentine Hypersensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Propolis

Propolis was applied by disposable micro brush on particular sensitive teeth and left undisturbed for 60 seconds to let it dry. Followup was done at 7th, 15th and 30th day

Group Type EXPERIMENTAL

Propolis

Intervention Type DRUG

Propolis was obtained from Margalla hills, Islamabad by NARC (National Agriculture Research Council, Islamabad). Plant source origin is Acacia modesta and Apis mellifera bees collect it. The 30% ethanolic extract of propolis from raw propolis was obtained in Pakistan Council of Scientific \& Industrial Research (PCSIR) by dissolving the propolis in 95% ethanol and straining out the precipitate

Seventh generation Dentine Bonding Agent (Scotchbond™ Universal Adhesive, 3M ESPE)

Application of Seventh generation Dentine Bonding Agent (Scotchbond™ Universal Adhesive, 3M ESPE) on sensitive surfaces was applied single coated for 20 seconds, gently applied air for 5 seconds and cured for 10 seconds (as per manufacturer's instructions). Followup was done at 7th, 15th and 30th day

Group Type ACTIVE_COMPARATOR

Dentin-Bonding Agents

Intervention Type DRUG

3M ESPE Scotchbond™ Universal Adhesive systems is a seventh generation single-bottled one-step self-etch adhesive system.

Interventions

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Dentin-Bonding Agents

3M ESPE Scotchbond™ Universal Adhesive systems is a seventh generation single-bottled one-step self-etch adhesive system.

Intervention Type DRUG

Propolis

Propolis was obtained from Margalla hills, Islamabad by NARC (National Agriculture Research Council, Islamabad). Plant source origin is Acacia modesta and Apis mellifera bees collect it. The 30% ethanolic extract of propolis from raw propolis was obtained in Pakistan Council of Scientific \& Industrial Research (PCSIR) by dissolving the propolis in 95% ethanol and straining out the precipitate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dow University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Ather Akber

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ather Akber, M.Sc

Role: PRINCIPAL_INVESTIGATOR

Dow University of Health Sciences

Locations

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Dow International Dental Campus (Defence Campus)

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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AAkber

Identifier Type: -

Identifier Source: org_study_id

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