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NCT Number: NCT04754763

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

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.

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Key information

Conditions

Dentine Hypersensitivity Dentin Sensitivity Stomatognathic Diseases Tooth Diseases

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Dow International Dental Campus (Defence Campus)

Karachi, Sindh, Pakistan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dentin-Bonding Agents

Drug

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

Propolis

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

Primary outcomes

  1. Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity

    Time frame: Before application of experimental agents (Day 0)

    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).

  2. Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity

    Time frame: Before application of experimental agents (Day 0)

    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

  3. Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity

    Time frame: 1 minute after application of experimental agents (Day 0)

    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.

  4. Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity

    Time frame: 1 minute after application of experimental agents (Day 0)

    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.

  5. Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity

    Time frame: Day 7

    Treatment of dentine hypersensitivity assessed with the help of Visual Analog Scale (VAS). Recordings were obtained on Day 7.

  6. Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity

    Time frame: Day 7

    Treatment of dentine hypersensitivity assessed with the help of Schiff Cold Air Sensitivity Scale. Recordings were obtained on Day 7.

  7. Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity

    Time frame: Day 15

    Treatment of dentine hypersensitivity assessed with the help of Visual Analog Scale (VAS). Recordings were obtained on Day 15.

  8. Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity

    Time frame: Day 15

    Treatment of dentine hypersensitivity assessed with the help of Schiff Cold Air Sensitivity Scale. Recordings were obtained on Day 15.

  9. Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity

    Time frame: Day 30

    Treatment of dentine hypersensitivity assessed with the help of Visual Analog Scale (VAS). Recordings were obtained on Day 30.

  10. Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity

    Time frame: Day 30

    Treatment of dentine hypersensitivity assessed with the help of Schiff Cold Air Sensitivity Scale. Recordings were obtained on Day 30.

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 15, 2021
Registry last updated
Feb 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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