An Early Phase 1 interventional study of Dentin-Bonding Agents and Propolis in Dentine Hypersensitivity, sponsored by Dow University of Health Sciences. Completed at 1 site in Pakistan. Open to participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-15.
Sponsored by Dow University of Health Sciences · Early Phase 1, Interventional, and Treatment
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.
283 studies on the registry are indexed under Dentin Sensitivity; 45 are open to participants now.
This study's enrollment of 52 is below the median of 60 across 274 interventional studies indexed under Dentin Sensitivity.
Browse Dentin Sensitivity studies →Dow University of Health Sciences is the lead sponsor of 170 studies on the registry; 30 are open to participants now.
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Exclusion Criteria:
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
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.
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
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).
Time frame: 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: 1. Subject does not respond to air stimulus. 2. Subject responds to air stimulus but does not request discontinuation of stimulus. 3. Subject responds to air stimulus and requests discontinuation or moves from stimulus. 4. 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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 30
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Dow University of Health Sciences