NCT05483062

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 28, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2022

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

6 months

First QC Date

July 28, 2022

Last Update Submit

October 17, 2023

Conditions

Tooth Sensitivity

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

toothpaste with active ingredient of galla chinensis

EXPERIMENTAL
Other: galla chinensis

toothpaste with stannous fluoride

ACTIVE COMPARATOR
Other: Stannous fluoride

Interventions

galla chinensisOTHER

toothpaste

toothpaste with active ingredient of galla chinensis
Stannous fluorideOTHER

Toothpaste

toothpaste with stannous fluoride

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Minya, Egypt

Location

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Galla chinensisTin Fluorides

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

FluoridesHydrofluoric AcidFluorine CompoundsInorganic ChemicalsTin CompoundsCariostatic AgentsBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

July 28, 2022

First Posted

August 1, 2022

Study Start

May 20, 2021

Primary Completion

November 23, 2021

Study Completion

June 25, 2022

Last Updated

October 18, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

Locations

EG(1)