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Single Group Clinical Study of a Self-Adhesive Resin Composite

A Single Group Clinical Study on the Efficacy and Safety of a Self-Adhesive Resin Composite in the Treatment of Root Caries

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032220616
Enrollment
70
Registered
2023-02-08
Start date
2023-04-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

root caries

Interventions

resin composite restoration

Sponsors

Shimada Yasushi
Lead Sponsor
Kuraray Noritake Dental
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Retention rate of filling

Secondary

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

Contacts

Public ContactGo Inoue

Institute of Science Tokyo Hospital

inoue.ope@tmd.ac.jp+81-3-5803-7362

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026