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A clinical study of the efficacy and safety of semiconductor laser for oral soft tissue vaporization, carbonization and coagulation

A clinical study of the efficacy and safety of semiconductor laser for oral soft tissue vaporization, carbonization and coagulation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000041216
Enrollment
Unknown
Registered
2020-12-22
Start date
2020-12-21
Completion date
Unknown
Last updated
2021-03-08

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

Conditions

Oral surgery disease

Interventions

Test group:Laser therapy (LX 16 Plus)
Control group:Laser therapy (Epic 10)

Sponsors

Hospital of Stomatology, Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Subjects aged 18-65 years old (including 18 and 65 years old), regardless of gender. 2. Subjects who need to use laser therapeutic apparatus to "vaporize, carbonize and coagulate oral soft tissue". 3. The patients, guardian or witness who has informed consent and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Mental patients and patients with cognitive impairment and inability to cooperate. 2. Subjects with pregnancy plan during pregnancy, lactation or nearly one month. 3. Patients with coagulation dysfunction and contraindication of surgery. 4. Patients with pacemakers. 5. Patients with severe immune dysfunction and contraindication of surgery. 6. Patients with severe organic lesions and intolerance to surgery. 7. Patients with obvious infection at the operation site. 8. Subjects with laser cutting tissue in contact with implants. 9. Patients with malignant tumor. 10. Subjects whose routine biochemical indexes are not in the normal range and whose abnormality is clinically significant according to the researcher's judgment. 11. Patients who have participated in clinical trials of other medical devices or drugs within 3 months. 12. Those subjects who are considered unsuitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Laser incision wound healing;Intraoperative laser hemostasis;

Secondary

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

Countries

China

Contacts

Public ContactJihong Zhao
jhzhao988@163.com+86 27-87686386

Outcome results

None listed

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