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

Primary Purpose

Dentine Hypersensitivity

Status
Completed
Phase
Early Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
Dentin-Bonding Agents
Propolis
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentine Hypersensitivity

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dow International Dental Campus (Defence Campus)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Propolis

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

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
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
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 14, 2021
Last Updated
February 12, 2021
Sponsor
Dow University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04754763
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
July 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentine Hypersensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propolis
Arm Type
Experimental
Arm Description
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
Arm Title
Seventh generation Dentine Bonding Agent (Scotchbond™ Universal Adhesive, 3M ESPE)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Dentin-Bonding Agents
Intervention Description
3M ESPE Scotchbond™ Universal Adhesive systems is a seventh generation single-bottled one-step self-etch adhesive system.
Intervention Type
Drug
Intervention Name(s)
Propolis
Intervention Description
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 Outcome Measure Information:
Title
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
Description
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).
Time Frame
Before application of experimental agents (Day 0)
Title
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
Description
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
Time Frame
Before application of experimental agents (Day 0)
Title
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
Description
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.
Time Frame
1 minute after application of experimental agents (Day 0)
Title
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
Description
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.
Time Frame
1 minute after application of experimental agents (Day 0)
Title
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
Description
Treatment of dentine hypersensitivity assessed with the help of Visual Analog Scale (VAS). Recordings were obtained on Day 7.
Time Frame
Day 7
Title
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
Description
Treatment of dentine hypersensitivity assessed with the help of Schiff Cold Air Sensitivity Scale. Recordings were obtained on Day 7.
Time Frame
Day 7
Title
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
Description
Treatment of dentine hypersensitivity assessed with the help of Visual Analog Scale (VAS). Recordings were obtained on Day 15.
Time Frame
Day 15
Title
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
Description
Treatment of dentine hypersensitivity assessed with the help of Schiff Cold Air Sensitivity Scale. Recordings were obtained on Day 15.
Time Frame
Day 15
Title
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
Description
Treatment of dentine hypersensitivity assessed with the help of Visual Analog Scale (VAS). Recordings were obtained on Day 30.
Time Frame
Day 30
Title
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
Description
Treatment of dentine hypersensitivity assessed with the help of Schiff Cold Air Sensitivity Scale. Recordings were obtained on Day 30.
Time Frame
Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ather Akber, M.Sc
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dow International Dental Campus (Defence Campus)
City
Karachi
State/Province
Sindh
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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