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Research for clinical efficacy and safety of the multi-center and single-group target value method of universal composite

Research for clinical efficacy and safety of the multi-center and single-group target value method of universal composite

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900021106
Enrollment
Unknown
Registered
2019-01-28
Start date
2018-10-01
Completion date
Unknown
Last updated
2019-02-04

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

Conditions

decayed tooth

Interventions

Case series:universal resin packing

Sponsors

Stomatological Hospital of the Fourth Military Medical University of the People's Liberation Army
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years old male and female with normal mouth opening; 2. healthy, without malignant tumors, cardiovascular and cerebrovascular diseases and other major systemic diseases; 3. if the degree of lesion reaches the defect of hard tissue in the middle layer of dentin, the pulp activity is normal and the following conditions should be met: (1) tooth position: all teeth; (2) hole type: I-type hole; (3) teeth without special stains, such as tetracycline teeth; (4) the tooth color is similar to that of the A2/A3 univesal resin; 4. the occlusion is natural, and the occlusion relationship is normal; 5. if the subject is a woman of childbearing age, pregnancy test should be conducted and the result is negative; 6. patients who agree to use experimental instruments for treatment and sign a written informed consent; 7. patients who are willing and able to follow up timely as required by the plan.

Exclusion criteria

Exclusion criteria: (1) allergy or multi-drug allergy;A history of allergy to polymer-based materials such as dental resin; (2) patients with severe periodontitis;Patients with poor oral health; Abnormal salivary gland function;Temporomandibular joint disorder; (3) patients with abnormal tooth wear (night molars, clenching habits), acid decay or cleft teeth, etc.; (4) DMFT=3; (5) abnormal occlusion, such as deep cladding; (6) patients with malignant tumors, cardiovascular and cerebrovascular diseases and other major systemic diseases; Women of child-bearing age and lactating women who are pregnant or intend to have a pregnancy within one year;Mentally ill; (7) subjects deemed unsuitable for inclusion by the researcher, such as poor compliance, etc.; (8) plan to go abroad within 1 year, or fail to complete 1-year postoperative follow-up due to other reasons; (9) the subjects participated in the clinical trials of other drugs or devices at the same time and did not reach the clinical end point;The subjects have participated in other clinical trials in the past 3 months; (10) cannot tolerate or use the rubber barrier; (11) patients undergoing orthodontic treatment.

Design outcomes

Primary

MeasureTime frame
Retention and fracture of backfill;Backfill body edge fracture;Shape and edge compatibility of backfill;Adjacent surface contact of backfil;

Secondary

MeasureTime frame
colour match;surfaceness;Surface coloring;

Countries

China

Contacts

Public ContactJinsong Wang
comriser@126.com+86 13861292768

Outcome results

None listed

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