Tooth SensitivityNCT05483062
Effectiveness of Toothpaste Containing the Active Ingredient of Galla Chinensis Extract on Treating Dentin Hypersensitivity
A study testing galla chinensis and Stannous fluoride in people with Tooth Sensitivity, run by Minia University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Sensitivity
- What is being tested?
- galla chinensis and Stannous fluoride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2021to 25 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Tooth Sensitivity
- Being tested
- galla chinensis, Stannous fluoride
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
galla chinensisOther
toothpaste
Stannous fluorideOther
Toothpaste
| Study group | Role | What they receive |
|---|---|---|
| toothpaste with active ingredient of galla chinensis | Experimental | Not described Receives: Other: galla chinensis |
| toothpaste with stannous fluoride | Active comparator | Not described Receives: Other: Stannous fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 )
Measured: 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start20 May 2021
- Primary completion23 Nov 2021
- Study completion25 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth SensitivityStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibram ibrahim morkous henein, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483062
- Sponsor's protocol ID
- Minia University Dentistry
- Status last verified
- Oct 2023
- First submitted
- 28 Jul 2022
- Last updated
- 18 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Toothpaste Containing the Active Ingredient of Galla Chinensis Extract on Treating Dentin Hypersensitivity '' A Randomized Clinical Trial ''
- ClinicalTrials.gov ID
- NCT05483062
- Acronym / sponsor ID
- Minia University Dentistry
- Conditions
- Tooth Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 23 Nov 2021 (actual)
- Study completion
- 25 Jun 2022 (actual)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| toothpaste with active ingredient of galla chinensis | Experimental | Other: galla chinensis |
| toothpaste with stannous fluoride | Active comparator | Other: Stannous fluoride |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| galla chinensistoothpaste | Other | toothpaste with active ingredient of galla chinensis |
| Stannous fluorideToothpaste | Other | toothpaste with stannous fluoride |
Primary outcome
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 )
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing galla chinensis and Stannous fluoride in people with Tooth Sensitivity, run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of pain level in response to stimuli (time frame: 6 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.