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

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

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.

Study Overview

• Status: Completed
• Conditions: Tooth Sensitivity
• Intervention / Treatment: Other: galla chinensis; Other: Stannous fluoride

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Minya, Egypt
    • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: toothpaste with active ingredient of galla chinensis	Other: galla chinensis; toothpaste
Active Comparator: toothpaste with stannous fluoride	Other: Stannous fluoride; Toothpaste

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Minia University

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2021
• Primary Completion (Actual): November 23, 2021
• Study Completion (Actual): June 25, 2022

Study Registration Dates

• First Submitted: July 28, 2022
• First Submitted That Met QC Criteria: July 29, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Stomatognathic Diseases; Tooth Diseases; Hypersensitivity; Dentin Sensitivity; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides; Tin Fluorides
• Other Study ID Numbers: Minia University Dentistry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No