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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propolis | Experimental | 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 |
|
| Seventh generation Dentine Bonding Agent (Scotchbond™ Universal Adhesive, 3M ESPE) | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dentin-Bonding Agents | Drug | 3M ESPE Scotchbond™ Universal Adhesive systems is a seventh generation single-bottled one-step self-etch adhesive system. |
|
| 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:
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ather Akber, M.Sc | Dow University of Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dow International Dental Campus (Defence Campus) | Karachi | Sindh | Pakistan |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 30, 2018 | Jan 30, 2021 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D017220 | Dentin-Bonding Agents |
| D011429 | Propolis |
| ID | Term |
|---|---|
| D003738 | Dental Cements |
| D003764 | Dental Materials |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
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| 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 |
|
| 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 |
| D013676 |
| Technology, Industry, and Agriculture |
| D012116 | Resins, Plant |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D053147 | Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |