crown restoration due to tooth defects, cracked teeth, or implant-supported single crowns
Conditions
Interventions
Test group:Crown restoration using a novel biomimetic resin infiltrated ceramic material (containing antibacterial components).
Control group:Crown restoration using VITA ENAMIC (PICN) dental ceramic block.
Sponsors
West China Hospital of Stomatology Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–70 (inclusive), regardless of gender; 2. Must meet one of the following criteria: (1) Teeth with structural defects requiring crown restoration; (2) Teeth with hidden cracks requiring crown restoration; (3) Single-tooth implant restoration for dental arch defects. 3. Normal mouth opening; 4. Sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Individuals with a history of allergies or hypersensitivity to multiple medications; those with a history of allergies to polymer-based materials such as dental resins or composite ceramics; 2. Patients with severe gingivitis or periodontitis; patients with poor oral hygiene; those with salivary gland dysfunction; patients with temporomandibular joint disorders; 3. Patients with systemic diseases or other conditions that may affect oral health; patients with mental health disorders; 4. Patients with pathological tooth wear (e.g., bruxism or teeth clenching) or dental erosion; 5. Patients with malocclusion, such as deep overbite; patients currently undergoing orthodontic treatment; 6. Pregnant women, women of childbearing age planning to become pregnant within one year, and lactating women; 7. Individuals planning to travel abroad within 12 months, or those unable to complete the 12-month post-operative follow-up for other reasons; 8. Participants currently enrolled in other drug or device clinical trials that have not reached their clinical endpoints; participants who have participated in other clinical trials within the past 3 months; 9. Patients using mouthwash during the study or follow-up period; 10. Individuals with allergies to methylene blue, polymethyl methacrylate, or sensitivity to light or red light; 11. Patients who have not taken systemic antibiotics for at least three months prior to the study; 12. Patients taking medications that affect metabolism on a long-term basis; 13. Patients who smoke during the study and follow-up periods; 14. Subjects deemed unsuitable for inclusion by the investigator, such as those with poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The survival rate of the restoration at 12 months post restoration; | — |
Secondary
| Measure | Time frame |
|---|---|
| The survival rate of the restoration at 1, 3, and 6 months post restoration;Plaque index(PLI): plaque index of the restoration and the control tooth in the test group and control group immediately after restoration, and at 1, 3, 6, and 12 months post restoration;Blood exposure of the antibacterial component;Satisfactory performance rate (durability, functionality, aesthetics); | — |
Countries
China
Contacts
Public ContactWu Yingying
West China Hospital of Stomatology Sichuan University
Outcome results
None listed