Conservative Dentistry with Hydroxyapatite

JRCT ID: jRCTs032220011

Registered date:08/04/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: 1. Caries 2. Hypersensitivity 3. Discolored teeth
• Date of first enrollment: 09/03/2023
• Target sample size: 60
• Study type: Interventional
• Intervention(s): A film composed of hydroxyapatite, which is the main component of teeth, is formed on teeth, and it blocks the stimulation to the pulp, occludes the dentinal tubulus and improves color tone of teeth.

Outcome(s)

Primary Outcome

"Caries"
(1) Evaluate the restoration for compatibility or detachment.
(2) Evaluate spontaneous pain in daily life and induced pain.

"Hypersensitivity"
(1) Evaluate the reduction of spontaneous pain in daily life and induced pain.
(2) Evaluate the damage in the gingiva.

"Discolored teeth"
(1) Evaluate the change in color tone by sensory evaluation.
(2) Evaluate the change in color tone with a spectrophotometer.
(3) Evaluate the satisfaction level of the subject.
(4) Evaluate the damage in the gingiva.

Secondary Outcome

"Caries"
Evaluate the efficiency of hydroxyapatite layer formation in the tooth cavity after caries removal and the feeling of usability by the operator.

"Hypersensitivity"
Evaluate the efficiency hydroxyapatite layer formation on the tooth surface with exposed dentin or wedge-shaped defects and the feeling of usability by the operator.

"Discolored teeth"
Evaluate the efficiency of forming a hydroxyapatite layer on the teeth, including at the cervical region, the lower solid void, and the contact point with the adjacent tooth and usability by the operator.

Key inclusion & exclusion criteria

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

Include criteria

1. Patients who can go to the hospital during the study period
2. Patients at least 20 years of age at enrolment date
3. Patients providing the written informed consent
4. In addition to the above, the selection criteria for each disease and the tooth to be examined are defined below
"Caries"
Patients who can be diagnosed as having caries localized in the enamel or dentin by inspection and X-ray examination, and which can be preserved and repaired by resin filling. The target is premolar or molar, and class1 cavity.
"Hypersensitivity"
Patients diagnosed with dentin hypersensitivity which can be confirmed by induced pain
"Discolored teeth"
Patients with a desire to whiten teeth
Patients with a desire to give their teeth a gloss
Patients providing informed consent for color change to sample color after treatment, and that the color tone of the contact point, lower solid void, and cervical region may not change. Up to three consecutive teeth shall be treated

Exclude criteria

1. Patients with oral mucosal disease
2. Patients with uncontrolled underlying disease
3. Patients who are lactating, pregnant, or intending to become pregnant
4. Patients who have pain caused by other disease and are taking drugs with analgesic effect
5. Patients who are otherwise considered ineligible for enrolling in the study by the principal investigator

Related Information

• Primary Sponsor: Miyazaki Chie
• Source(s) of Monetary Support: SANGI CO.,LTD.