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Clinical Evaluation of Diode Laser Therapeutic Apparatus

Clinical trial of efficacy and safety evaluation of semiconductor laser therapeutic instrument for oral soft tissue incision and gingivectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076509
Enrollment
Unknown
Registered
2023-10-10
Start date
2023-10-10
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

"For oral soft tissue incision, gingivectomy" patients

Interventions

Test group:Oral soft tissue cutting using semiconductor laser therapeutic instrument (model specification: SOLASE Pro-31) produced by Lazon Medical Laser

Sponsors

Stomatology Hospital, School of Stomatology, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18-70 years old (including 18 and 70 years old), gender is not limited. (2) Subjects who require oral soft tissue incision and gingivectomy. (3) The person, guardian or witness gives informed consent and has signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Mental patients and those with cognitive dysfunction and unable to cooperate. (2) Those who are pregnant, lactating or have pregnancy plans in the past month. (3) Those with tooth extraction contraindications: acute infection, acute infectious disease, hyperthyroidism, severe organic disease (such as heart disease, blood disease, acute hepatitis, acute kidney disease, etc.), malignant tumors and other tooth extraction contraindications wait. (4) Those with a history of diabetes and poor blood sugar control (glycated hemoglobin >7.5%). (5) People with cardiac pacemakers. (6) The laser irradiation site is close to implants or metal restorations. (7) Those whose blood routine and coagulation function tests are not within the normal range, and the researcher determines that the abnormality has clinical significance. (8) Those who have participated in clinical trials of other medical devices or drugs within 3 months. (9) The researchers think that it is not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Laser incision wound healing 7 days after operation;Intraoperative hemostatic effect;

Secondary

MeasureTime frame
Intraoperative laser cutting efficiency;Disinfection convenience, operation convenience, safety and stability;

Countries

China

Contacts

Public ContactChuanxia Liu

Stomatology Hospital, School of Stomatology, Zhejiang University School of Medicine

0014806@zju.edu.cn+86 157 0010 6621

Outcome results

None listed

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