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Completed

NCT Number: NCT05483062

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Minya, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

galla chinensis

Other

toothpaste

Stannous fluoride

Other

Toothpaste

Primary outcomes

  1. Change of pain level in response to stimuli

    Time frame: 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 )

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Aug 1, 2022
Registry last updated
Oct 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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