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

Tooth Sensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05483062
• Other study ID #: Minia University Dentistry
• Status: Completed
• Phase: N/A
• Start date: May 20, 2021
• Est. completion date: June 25, 2022

Study information

• Verified date: October 2023
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 25, 2022
• Est. primary completion date: November 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dentin Sensitivity
• Hypersensitivity
• Tooth Sensitivity

Intervention

Other:
• galla chinensis
toothpaste
• Stannous fluoride
Toothpaste

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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