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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900021098
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:Filling the cavity with flow resin

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 to 70 years, no gender restriction, 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: v-type hole; (3) Teeth without special stains, such as tetracycline teeth; (4) The tooth color is similar to that of the A2/A3 flow 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;

Secondary

MeasureTime frame
Adjacent surface contact of backfil;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