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A multi-center, randomized controlled, single-blind, non-inferiority clinical trial to evaluate the safety and effectiveness of light-curing composite resins for cavity filling and dental defect restoration

A multi-center, randomized controlled, single-blind, non-inferiority clinical trial to evaluate the safety and effectiveness of light-curing composite resins for cavity filling and dental defect restoration

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054200
Enrollment
Unknown
Registered
2021-12-11
Start date
2022-02-01
Completion date
Unknown
Last updated
2022-11-14

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

Conditions

Tooth defect requires filling of the front and back cavity and restoration of the tooth defect

Interventions

Experimental group:Light-curing composite resin
Control group:Light-curing composite resin (Filtek Z350XT Universal Restorative)

Sponsors

The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Good health, aged 18 to 70 years (including 18 and 70 years old), no gender limit; 2. The opening degree is normal; 3. The test tooth is a decayed tooth whose lesion depth reaches the middle layer of dentin, and the pulp vitality is normal, and the following conditions must be met: (1) Tooth position: unlimited; (2) Hole type: type I or type II hole; (3) Hole size: the smallest buccal and tongue diameter of the occlusal surface is not less than 1/3 of the distance between the buccal and tongue tips; the gingival scalp is located on the crown of the gingival margin after the cavity is prepared on the adjacent surface; (4) Occlusal: all fillings must have occlusal contact immediately after restoration; the opposite occlusion is a natural tooth; the occlusal relationship is normal; (5) Adjacent surface contact: all type II hole filling bodies must be in contact with adjacent surfaces and the contact relationship should be restored. When the third molar is missing, the mesial occlusal surface (MO) and the mesial-distal occlusal surface (MOD) fillings of the second molar are acceptable, but the distal occlusal (DO) fillings are not included; (6) The teeth have no special color, such as special staining, dental fluorosis, tetracycline teeth, etc.; 4. The patient voluntarily participated and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Those with allergies or multiple drug allergies; those with a history of allergies to polymer-based materials such as dental resins; 2. Patients with severe caries, severe periodontitis, poor oral hygiene, abnormal salivary gland function, temporomandibular joint disorders; 3. Patients with non-caries dental diseases such as pathological wear (night bruxism, clenching habit), acid erosion or cracking; 4. DMFT (missing complement index) >= 6; 5. Those who are receiving orthodontic treatment; 6. Those who cannot tolerate or cannot use rubber barriers; 7. Women of childbearing age and lactating women who are pregnant and intended to become pregnant; male patients of childbearing age whose partners intend to become pregnant; 8. Patients with mental illness; 9. Patients have participated in or is participating in clinical trials of other drugs or devices within the past 3 months; 10. Patients considered by the investigator to be unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Filling success rate after repair;

Secondary

MeasureTime frame
Evaluation of filling effect after repair;

Countries

China

Contacts

Public ContactJiang Xinquan

The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine

xinquanj@aliyun.com+86 13916918511

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026