Efficacy of Miswak Extract Toothpaste as Compared Potassium Nitrate in The Management of Dentinal Hypersensitivity
NCT ID: NCT04179994
Last Updated: 2019-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
96 participants
INTERVENTIONAL
2020-01-01
2020-07-25
Brief Summary
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Detailed Description
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After allocation, all subjects will be instructed to refrain from using any desensitizing agents for two weeks prior to the study up to the end of study period. The randomization process will be made using SPSS, the function "RAND" to assign every subject to random A, B, or C masked toothpastes. Moreover, to insure the blinded process of the study we will dispense the toothpastes in a previously prepared similar containers in separate area. Two trained examiners will read and record the scores each visit (baseline, 2-weeks, and 6-weeks). For the seek of examiners' calibration, Kappa statistic will be used to assess the inter-rater reproducibility and we will duplicate a 10% of the study results.
During each visit, teeth around the targeted tooth will be isolated with cotton rolls then the stimuli will be applied using a sharp dental explorer. It will be passed across the facial area of the tooth, perpendicular to the tooth long axis. The average of three consecutive applications will be recorded as a the reading for that tooth.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Miswak extract-containing toothpaste group
Test group.
Miswak extract-containing toothpaste
Miswak extract-containing toothpaste will be applied to the tooth diagnosed with DH
Toothpaste containing Potassium Nitrates
Positive control.
Potassium nitrates-containing toothpaste
Potassium nitrates-containing toothpaste will be applied to the tooth diagnosed with DH
Placebo group
Toothpaste contains same ingredients of test group except for the active ingredient as negative control.
Placebo
A toothpaste containing the same ingredients of the test toothpaste except for the active ingredient
Interventions
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Miswak extract-containing toothpaste
Miswak extract-containing toothpaste will be applied to the tooth diagnosed with DH
Potassium nitrates-containing toothpaste
Potassium nitrates-containing toothpaste will be applied to the tooth diagnosed with DH
Placebo
A toothpaste containing the same ingredients of the test toothpaste except for the active ingredient
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects show good general health
* Must have at least two teeth with VAS score of 4 or more
Exclusion Criteria
* Subjects allergic to ingredients used in the study
* Subjects present any oral pathology, eating disorders, chronic disease, or any disease requiring repeated or regular analgesia, anti-inflammatory drugs, or antihistamines
20 Years
55 Years
ALL
Yes
Sponsors
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Ministry of Health, Saudi Arabia
OTHER_GOV
Responsible Party
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Abdulrahman Alshehri
Principal Investigator
Principal Investigators
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Abdulrahman Alshehri, MS
Role: PRINCIPAL_INVESTIGATOR
Ministry of Health, Saudi Arabia
Central Contacts
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References
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Al-Otaibi M, Al-Harthy M, Gustafsson A, Johansson A, Claesson R, Angmar-Mansson B. Subgingival plaque microbiota in Saudi Arabians after use of miswak chewing stick and toothbrush. J Clin Periodontol. 2004 Dec;31(12):1048-53. doi: 10.1111/j.1600-051X.2004.00618.x.
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Canadian Advisory Board on Dentin Hypersensitivity. Consensus-based recommendations for the diagnosis and management of dentin hypersensitivity. J Can Dent Assoc. 2003 Apr;69(4):221-6.
Cunha-Cruz J, Wataha JC, Heaton LJ, Rothen M, Sobieraj M, Scott J, Berg J; Northwest Practice-based Research Collaborative in Evidence-based DENTistry. The prevalence of dentin hypersensitivity in general dental practices in the northwest United States. J Am Dent Assoc. 2013 Mar;144(3):288-96. doi: 10.14219/jada.archive.2013.0116.
Douglas-de-Oliveira DW, Vitor GP, Silveira JO, Martins CC, Costa FO, Cota LOM. Effect of dentin hypersensitivity treatment on oral health related quality of life - A systematic review and meta-analysis. J Dent. 2018 Apr;71:1-8. doi: 10.1016/j.jdent.2017.12.007. Epub 2017 Dec 17.
Dowell P, Addy M. Dentine hypersensitivity--a review. Aetiology, symptoms and theories of pain production. J Clin Periodontol. 1983 Jul;10(4):341-50. doi: 10.1111/j.1600-051x.1983.tb01283.x.
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Holland GR, Narhi MN, Addy M, Gangarosa L, Orchardson R. Guidelines for the design and conduct of clinical trials on dentine hypersensitivity. J Clin Periodontol. 1997 Nov;24(11):808-13. doi: 10.1111/j.1600-051x.1997.tb01194.x.
Markowitz K, Kim S. The role of selected cations in the desensitization of intradental nerves. Proc Finn Dent Soc. 1992;88 Suppl 1:39-54.
Rees JS, Addy M. A cross-sectional study of buccal cervical sensitivity in UK general dental practice and a summary review of prevalence studies. Int J Dent Hyg. 2004 May;2(2):64-9. doi: 10.1111/j.1601-5029.2004.00068.x.
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Other Identifiers
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MoHSaudiArabia
Identifier Type: -
Identifier Source: org_study_id