Single Group Clinical Study of a Self-Adhesive Resin Composite

JRCT ID: jRCTs032220616

Registered date:08/02/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: root caries
• Date of first enrollment: 10/04/2023
• Target sample size: 70
• Study type: Interventional
• Intervention(s): resin composite restoration

Outcome(s)

• Primary Outcome: Retention rate of filling

Secondary Outcome

(1) Color compatibility
(2) Postoperative pain
(3) Secondary caries formation
(4) Margin compatibility
(5) Discoloration of margins

Key inclusion & exclusion criteria

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

Include criteria

(1)Patients who are considered to have a cavity with a maximum diameter of 4 mm and a depth of 2 mm or less after root caries removal.
(2)Patients who are outpatients of the institution.
(3)Men or women who are over 20 years old at the time that a consent is obtained.
(4)Patients who have given written consent to participate in this clinical research.

Exclude criteria

(1)Cavities that exceed 4 mm in maximum diameter and 2 mm in depth after caries removal
(2)Cavities that the principal investigator determines to be unsuitable for filling such as they exist under the gingival margin or cannot be controlled moisture
(3)More than one cavity to be treated on a tooth
(4)Cavities in which the Principal Investigator determines that the adhesive surface contains a material other than tooth substance (e.g., metal, ceramic, resin composite, etc.)
(5)Patients who are diagnosed by the Principal Investigator to have acidic erosion.
(6)Patients suffering from a disease requiring urgent treatment or having a serious complication
(7)Patients with a history of hypersensitivity such as rash or dermatitis to methacrylic acid monomers
(8)Patients who are currently participating or intend to participate in studies of other drugs, medical devices, or food products.
(9)Patients who are pregnant or have the possibility of pregnancy
(10)Patients who are breast-feeding.
(11)Other subjects who are judged by the principal investigator (subinvestigator) to be inappropriate to participate in the study.

Related Information

• Primary Sponsor: Shimada Yasushi
• Secondary Sponsor: Kuraray Noritake Dental