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

Not Applicable

Completed

• Conditions: Tooth Sensitivity
• Interventions: Other: galla chinensis; Other: Stannous fluoride

• Registration Number: NCT05483062
• Lead Sponsor: Minia University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-20
• Primary Completion: 2021-11-23
• Study Completion: 2022-06-25
• Study First Submitted: 2022-07-28
• Study First Submitted QC: 2022-07-29
• Study First Posted: 2022-08-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
toothpaste with active ingredient of galla chinensis	galla chinensis	-
toothpaste with stannous fluoride	Stannous fluoride	-

Primary Outcome Measures

Name	Time	Method
Change of pain level in response to stimuli	6 months follow up	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 )

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Minya, Egypt