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

A Comparative Study On The Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Dentine Hypersensitivity
• Intervention / Treatment: Drug: Propolis; Drug: Dentin-Bonding Agents

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • Dow International Dental Campus (Defence Campus)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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
Active Comparator: 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	Drug: Dentin-Bonding Agents; 3M ESPE Scotchbond™ Universal Adhesive systems is a seventh generation single-bottled one-step self-etch adhesive system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity	Treatment of dentine hypersensitivity assessed with the help of Visual Analog Scale (VAS). Recordings were obtained at Day 0, before the application of experimental agents. Visual Analog Scale which will be scored as 0 (No Pain), 1-3 (Mild Pain), 4-6 (Moderate Pain) and 7-10 (Severe Pain).	Before application of experimental agents (Day 0)
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity	Treatment of dentine hypersensitivity assessed with the help of Schiff Cold Air Sensitivity Scale. Recordings were obtained at Day 0, before the application of experimental agents. Schiff Cold Air Sensitivity Scale is mainly used to evaluate subject response to a stimulus like air or evaporative. This scale is scored as follows: Subject does not respond to air stimulus.; Subject responds to air stimulus but does not request discontinuation of stimulus.; Subject responds to air stimulus and requests discontinuation or moves from stimulus.; Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus	Before application of experimental agents (Day 0)
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity	Treatment of dentine hypersensitivity assessed with the help of Visual Analog Scale (VAS). Scale. Recordings were obtained at Day 0, after the application of experimental agents.	1 minute after application of experimental agents (Day 0)
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity	Treatment of dentine hypersensitivity assessed with the help of Schiff Cold Air Sensitivity Scale. Recordings were obtained at Day 0, after the application of experimental agents.	1 minute after application of experimental agents (Day 0)
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity	Treatment of dentine hypersensitivity assessed with the help of Visual Analog Scale (VAS). Recordings were obtained on Day 7.	Day 7
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity	Treatment of dentine hypersensitivity assessed with the help of Schiff Cold Air Sensitivity Scale. Recordings were obtained on Day 7.	Day 7
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity	Treatment of dentine hypersensitivity assessed with the help of Visual Analog Scale (VAS). Recordings were obtained on Day 15.	Day 15
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity	Treatment of dentine hypersensitivity assessed with the help of Schiff Cold Air Sensitivity Scale. Recordings were obtained on Day 15.	Day 15
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity	Treatment of dentine hypersensitivity assessed with the help of Visual Analog Scale (VAS). Recordings were obtained on Day 30.	Day 30
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity	Treatment of dentine hypersensitivity assessed with the help of Schiff Cold Air Sensitivity Scale. Recordings were obtained on Day 30.	Day 30

Collaborators and Investigators

• Sponsor: Dow University of Health Sciences
• Investigators: Principal Investigator: Ather Akber, M.Sc, Dow University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): May 31, 2019
• Study Completion (Actual): July 30, 2019

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: February 12, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): February 15, 2021
• Last Update Submitted That Met QC Criteria: February 12, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Stomatognathic Diseases; Tooth Diseases; Hypersensitivity; Dentin Sensitivity; Anti-Infective Agents; Propolis
• Other Study ID Numbers: AAkber

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No