Clinical study of Mondahmin DH-1N on dentin hypersensitivity

JRCT ID: jRCT1060210067

Registered date:05/01/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Dentin hypersensitivity
• Date of first enrollment: 05/01/2022
• Target sample size: 150
• Study type: Interventional
• Intervention(s): Distribute the designated toothpaste, mouthwash or liquid toothpaste, and check the mouthwash status and the absence of prohibited medications.

Outcome(s)

Primary Outcome

Evaluation of abrasion pain, cold air pain, and subjective evaluation using the criteria shown in the table below.
(1) Abrasion pain: The tooth surface is rubbed perpendicularly at a constant pressure (40g) using a probe capable of applying a constant pressure to the cervical area.
The adjacent tooth is covered with gauze to isolate it from the test tooth, and pressurized air (0.38 MPa) is blown on the labial cervical region of the test tooth for 1 second. The physician in charge performs calibration using the measuring instruments.
(3) Subjective evaluation: The physician in charge will evaluate the subject's own hypersensitivity state in daily life by interviewing the subject.

Secondary Outcome

After the start of the study, the dentist in charge of the study should record the date of onset of symptoms (adverse reactions) and their severity, details, treatment details, progress, and causal relationship to the study drug.
(1) Degree of symptoms
+++: Severe (discontinuation of use of the study drug)
++: Moderate (continued use is possible with treatment)
+: Mild (degree is mild and does not require special treatment)
(2) Causal relationship
1: Clearly related
2: Probably related
3: May be related
4: Apparently not related
5: No association
If any of the following applies, the reason should be stated.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Those who meet all of the following criteria are eligible
(1) Have at least one tooth that is judged to have a score of 1 or 2 on the criteria in Section 6 for abrasion and cold air stimulation.
(2) Those who are 20 years of age or older at the time of consent (regardless of gender).
(3) Patients who, after receiving sufficient explanation and understanding, have given their free written consent to participate in this study.

Exclude criteria

Patients who violate any of the following will not be included in this study
(1) Patients who regularly use medications that may affect the judgment of the study (antiallergic agents, antibiotics, anti-inflammatory analgesics, etc.), or toothpastes that have a preventive effect on dentin hypersensitivity
(2) Those who are undergoing treatment for dentin hypersensitivity or are in need of treatment.
(3) Those suffering from serious oral diseases (caries, periodontal diseases, etc.) and those undergoing treatment for these diseases
(4) Persons suffering from systemic diseases (liver disease, circulatory disease, etc.) and persons undergoing treatment for these diseases
(5) Patients who are judged by the principal investigators and sub-investigators to be inappropriate as research subjects.
Rationale for setting
Because of the effect on efficacy evaluation

Related Information

• Primary Sponsor: Masahiro Yoshiyama