Effectiveness of Toothpaste Containing the Active Ingredient of Galla Chinensis Extract on Treating Dentin Hypersensitivity

Study Overview
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Brief Summary
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This clinical trial was conducted to compare the desensitizing effect of toothpaste containing the active ingredient of an extract of Galla chinensis and toothpaste containing fluoride in patients with dentin hypersensitivity.

Official Title
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Effectiveness of Toothpaste Containing the Active Ingredient of Galla Chinensis Extract on Treating Dentin Hypersensitivity '' A Randomized Clinical Trial ''

Conditions
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Tooth Sensitivity

Intervention / Treatment
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* Other: galla chinensis
* Other: Stannous fluoride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years. Overall good oral hygiene status. Participants show tooth neck abrasion or gingival retraction. Patients have subjective dentin hypersensitivity (at least 1 tooth) after using airflow. No history of periodontal treatment, including periodontal surgery, in the past year. Written informed consent Exclusion Criteria: Patient with severe periodontitis or severe erosion damage. Patients with a compromised medical history, or had received therapeutic irradiation to the head and neck region. Medically compromised patients where pain levels would be compromised. If analgesics or antibiotics have been administrated by the patient during the past 12 hours preoperatively as it might alter their pain perception. Patients reporting bruxism or clenching in order to avoid further pressure on an already hypersensitive tooth inducing subsequent irritation and inflammation. Teeth that show association with acute periapical abscess and swelling. Greater than grade I mobility or pocket depth greater than 5mm. Non-restorable teeth or hopeless teeth. Immature teeth. Radiographic evidence of external or internal root resorption. Alcoholic and smoker patients. Pregnant or breastfeeding ladies. Patients having physical disabilities, or who are unable to brush their teeth Patients who have a history of allergies to any personal oral care product or ingredient, or who are taking anti-inflammatory drugs within the previous month. Individuals who had sensitive teeth but with one of the following conditions will be excluded from the study, teeth with large restorations, abutment of teeth of removable partial dentures, dental caries, enamel cracks, leakage of fillings or other restorations, cracked 23 teeth, dental pulp lesions, dental abscesses, pulpitis, and atypical facial pain. Patients had participated in a clinical trial within 6 months before commencement of this trial. Patients unable to return for recall appointment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: toothpaste with active ingredient of galla chinensis<br> | Other: galla chinensis<br>* toothpaste<br>|
| Active Comparator: toothpaste with stannous fluoride<br> | Other: Stannous fluoride<br>* Toothpaste<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of pain level in response to stimuli | Teeth were evaluated at baseline (T0), 1week (T1), 2 weeks (T2), 4 weeks (T3), 3 months (T4), and 6 months (T5) after using different types of toothpastes using Visual Analog Scale (VAS) scoring from 0-10 while 0 mean no pain and 10 severe pain by sensitivity tests (schiff test ) | 6 months follow up |