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

NCT ID: NCT05483062

Last Updated: 2023-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-20
• Study Completion Date: 2022-06-25

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.

Conditions

Tooth Sensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

toothpaste with active ingredient of galla chinensis

Group Type: EXPERIMENTAL

galla chinensis

Intervention Type: OTHER

toothpaste

toothpaste with stannous fluoride

Group Type: ACTIVE_COMPARATOR

Stannous fluoride

Intervention Type: OTHER

Toothpaste

Interventions

galla chinensis

toothpaste

Intervention Type: OTHER

Stannous fluoride

Toothpaste

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minia University

OTHER

Sponsor Role: lead

Responsible Party

Ibram ibrahim morkous henein

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Dentistry

Minya, , Egypt

Countries

Egypt

Other Identifiers

Minia University Dentistry

Identifier Type: -

Identifier Source: org_study_id