Effect of mouthwash on dentin hypersensitivity

JRCT ID: jRCT1060230066

Registered date:12/10/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Dentin hypersensitivity
• Date of first enrollment: 12/10/2023
• Target sample size: 150
• Study type: Interventional
• Intervention(s): Distribute designated toothpaste, mouthwash, or liquid toothpaste, and check for mouthwash status and prohibited medications

Outcome(s)

Primary Outcome

The physician in charge will check and judge the score applicable to the study subject using the 11-point scale (NRS) from 0 to 10 shown below for three points: abrasion pain, cold air pain, and cold water pain The criteria for the NRS score are shown in the table below.
1. Abrasive pain: Rubbing at right angles at a constant pressure (probe: 40g, toothbrush: 250g) against the tooth surface using a probe and toothbrush capable of applying a constant pressure on the tooth neck.
2. Cold sore: The adjacent teeth are isolated from the test tooth by covering them with gauze, etc. and compressed air (0.38 MPa) is blown on the labial side of the test tooth for 1 second. The physician in charge performs calibration using a measuring instrument.
3. Cold water pain: Dip a cotton ball in water chilled in a refrigerator and bring it into contact with the test tooth.
Each of the three main items will be evaluated separately, and an overall judgment will be made based on the results of each.

Secondary Outcome

The physician in charge will conduct a medical interview to determine the hypersensitivity status of the research subjects themselves in their daily lives by using the NRS, and the physician in charge will check and determine the score applicable to the research subject.
In addition, the principal investigator or subinvestigator will record the date of onset, contents, treatment, course, and causal relationship to the study product, etc., of any newly developed symptoms (adverse reactions) and their degree after the start of the study.
(1) Degree of symptoms
2) Causal relationship

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Subjects who meet all of the following criteria will be included
(1) Have at least one tooth that scores 7 or 8 on the NRS in response to abrasion and cold water stimulation.
(2) Age 18 years or older at the time of consent (regardless of gender)
(3) Patients who have been fully informed of the study and who have given written consent of their own free will.

Exclude criteria

Patients who fall into any of the following categories shall not be included in the study.
1. Patients who are regularly using drugs (antiallergic agents, antibiotics, anti-inflammatory analgesics, etc.) or dentifrice with prophylactic effect on dentin hypersensitivity that may affect the study's judgment.
2. Persons who are receiving treatment for dentin hypersensitivity or are in need of such treatment.
3. Persons suffering from serious oral diseases (caries, periodontal disease, etc.) and persons undergoing treatment for these diseases (however, persons undergoing treatment for minor oral diseases shall be excluded).
4. Persons suffering from systemic diseases that may affect the study's decision, and persons undergoing treatment for such diseases.
5. Other patients who are deemed inappropriate as study subjects by the principal investigator or principal study author.
6. Patients who have previously participated in human use studies related to "Mondamine DH-1N for Medicinal Use".
7. Persons with expertise in oral hygiene (dental school students, faculty members, etc.) [Basis for setting] Due to its impact on efficacy evaluation.

Related Information

• Primary Sponsor: Kei Takahashi
• Source(s) of Monetary Support: Earth Chemical Co.