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

Primary Purpose

Tooth Sensitivity

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

galla chinensis

Stannous fluoride

About this trial

This is an interventional treatment trial for Tooth Sensitivity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

toothpaste with active ingredient of galla chinensis

toothpaste with stannous fluoride

Arm Description

Outcomes

Primary Outcome Measures

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 )

Secondary Outcome Measures

Full Information

NCT ID

NCT05483062

First Posted

July 28, 2022

Last Updated

October 17, 2023

Sponsor

Minia University

1. Study Identification

Unique Protocol Identification Number

NCT05483062

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

May 20, 2021 (Actual)

Primary Completion Date

November 23, 2021 (Actual)

Study Completion Date

June 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Minia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tooth Sensitivity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

toothpaste with active ingredient of galla chinensis

Arm Type

Experimental

Arm Title

toothpaste with stannous fluoride

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

galla chinensis

Intervention Description

toothpaste

Intervention Type

Other

Intervention Name(s)

Stannous fluoride

Intervention Description

Toothpaste

Primary Outcome Measure Information:

Title

Change of pain level in response to stimuli

Description

Time Frame

6 months follow up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Faculty of Dentistry

City

Minya

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

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

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