Efficacy of Miswak Extract Toothpaste as Compared Potassium Nitrate in The Management of Dentinal Hypersensitivity

Study Overview
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Brief Summary
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The study will be a single-center, longitudinal, triple-masked (for participants, operators, and statistician), equal ratio, randomized non-crossover design. The study designed following the criteria described by Holland et al 1997. The current experiments will follow CONSORT guidelines and will be registered at the US National Institutes of Health (ClinicalTrials.gov). The sensitivity scores will be measured at three intervals: at baseline, at 2 weeks, and at 6 weeks. The duration of the current study estimated to be 6 weeks and will be conducted between January 2020 and March 2020. The study protocol will be submitted initially to the Ethical Committee of the Aseer Central Hospital, Aseer region, Saudi Arabia. After getting the approval and facilitation letters, the participants will be selected randomly from patients attending periodontal clinics at Aseer Dental Center, Aseer region.

Detailed Description
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Three toothpastes will be investigated during the study period that are 1) commercially available miswak extract-containing toothpaste; 2) commercially available toothpaste containing 5% potassium nitrate as positive control; 3) a toothpaste containing the same formulation as miswak extract except for the active ingredient (miswak extract) as negative control. Toothpastes will be dispensed in labeled containers named A,B, and C to achieve the triple masking for investigators, participants, and statisticians. Masked toothpastes will be revealed to the investigators after the statistical analyses. 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.

Official Title
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Comparison of Clinical Efficacy of a Miswak Extract-Containing Toothpaste to a Dentifrice Containing Potassium Nitrate and to a Placebo on Dentinal Hypersensitivity: A Randomized Clinical Trial

Conditions
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Dentine Hypersensitivity

Intervention / Treatment
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* Other: Miswak extract-containing toothpaste
* Other: Potassium nitrates-containing toothpaste
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with history of DH caused by cervical erosion or gingival recession Subjects show good general health Must have at least two teeth with VAS score of 4 or more Exclusion Criteria: Subjects have teeth with caries, occlusal restorations, or orthodontic appliances 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study will be a single-center, longitudinal, triple-masked (for participants, operators, and statistician), equal ratio, randomized non-crossover design.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Miswak extract-containing toothpaste group<br>Test group. | Other: Miswak extract-containing toothpaste<br>* Miswak extract-containing toothpaste will be applied to the tooth diagnosed with DH<br>* Other names: Test group;|
| Active Comparator: Toothpaste containing Potassium Nitrates<br>Positive control. | Other: Potassium nitrates-containing toothpaste<br>* Potassium nitrates-containing toothpaste will be applied to the tooth diagnosed with DH<br>* Other names: Positive control;|
| Placebo Comparator: Placebo group<br>Toothpaste contains same ingredients of test group except for the active ingredient as negative control. | Other: Placebo<br>* A toothpaste containing the same ingredients of the test toothpaste except for the active ingredient<br>* Other names: Negative control as placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain reduction | Visual Analog Scale (VAS) will be used to measure pain intensity. The scale is graded from 1 to 10 with zero score indicates a pain-free response and 10 indicates sever pain or discomfort. | 6 weeks period |