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A multicenter randomized controlled trial to evaluate the efficacy and safety of a thulium fiber laser device for root canal irrigation

A multicenter randomized controlled trial to evaluate the efficacy and safety of a thulium fiber laser device for root canal irrigation

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122449
Enrollment
Unknown
Registered
2026-04-14
Start date
2023-05-09
Completion date
Unknown
Last updated
2026-04-20

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

Conditions

Chronic apical periodontitis

Interventions

Control group:Er:YAG laser
Trial group:Thulium fiber laser

Sponsors

Xuanwu Hospital Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 80 years (inclusive), regardless of gender. 2. Patients with chronic apical periodontitis in anterior or premolar teeth exhibiting closed apical foramina. 3. Teeth with a periapical radiolucency diameter <=5 mm. 4. Subjects voluntarily participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with severe systemic diseases. 2. Individuals with mental disorders or cognitive dysfunction who are unable to cooperate. 3. Patients with a cardiac pacemaker. 4. Patients with malignant tumors or those who have undergone radiotherapy in the head and neck region. 5. Teeth that have previously received root canal treatment. 6. Teeth presenting with root fracture, calcified root canal, root resorption, severe periodontal disease, or a sinus tract. 7. Teeth with mobility = Grade II. 8. Patients with severe bruxism or malocclusion. 9. Individuals who have used antibiotics within the past week. 10. Patients with radicular cysts. 11. Women who are pregnant, lactating, or planning pregnancy within the next three months. 12. Individuals who have participated in another clinical trial within the past three months. 13. Individuals deemed by the investigator to be unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Absence or reduction rate of percussion pain after root canal irrigation;

Secondary

MeasureTime frame
Improvement rate of periapical tissue imaging;VAS pain score;Post-obturation percussion pain;Tooth mobility;

Countries

China

Contacts

Public ContactZhao Ying

Xuanwu Hospital Capital Medical University

zhying19@aliyun.com+86 139 1016 5600

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 23, 2026