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
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Basic Information
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COMPLETED
EARLY_PHASE1
52 participants
INTERVENTIONAL
2018-06-01
2019-07-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
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
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
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
Dentin-Bonding Agents
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.
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
Eligibility Criteria
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Inclusion Criteria
* 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 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
20 Years
45 Years
ALL
Yes
Sponsors
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Dow University of Health Sciences
OTHER
Responsible Party
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Ather Akber
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
Countries
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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AAkber
Identifier Type: -
Identifier Source: org_study_id
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