Clinical Study about Root Canal Treatment with Laser application.

Phase 2

Recruiting

• Conditions: Pulpitis, pulp necrosis or apical periodontitis; Pulpitis, apical periodontitis; D011671, D003790, D010485

• Registration Number: JPRN-jRCTs032220637
• Lead Sponsor: Watanabe Satoshi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-13
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Patients aged 18 years old or more who can acquire written consent by themselves for participation in this study and who meet both of the following conditions will be selected.
1. Patients need initial root canal treatment.
2. Patients aged 18 years old or more and below 80.
3. Patients who have been fully informed of the study and who have given written consent of their own free will after full understanding of the study.

Exclusion Criteria

The following patients are excluded from this study.
1. Patient tooth with symptomatic inflammation which need root canal treatment (VAS >4 mm)
2. Patients need more than two-day root canal treatment for complicated root canal.
3. Patients diagnosed with root fracture.
4. Patients with severe blood disorders.
5. Patients with bone target hormone metabolic disorders or patients who are suspected to have the abnormalities of calcium metabolism organs such as kidney and gastrointestinal tract.
6.Patients under dialysis treatment or steroid use and patients who are suspected to have collagenosis.
7. Uncontrolled diabetes mellitus patients who have had not adequate glycemic control (HbA1c less than 6.9%).
8. Patients with severe heart disease (valvular heart disease, cardiomyopathy, myocardial infarction, angina pectoris, etc)
9. Patient with cardiac pacemaker or implantable cardioverter defibrillator.
10. Patients with uncontrollable complications that are restricted from observing the requirements of this clinical research, such as severe disease (infection, immunodeficiency, hyperthyroidism, etc) or epilepsy, psychiatric disorder.
11. Patients with or with a history of malignant tumors.
12. Patients under anti-resorptive agents medication.
13. Patient with alcohol/drug addiction.
14. Patients who participated in clinical studies with interventions for other medical devices or drugs within the past 3 months.
15. Patients who fall into any of the following categories
: pregnant, possibly pregnant, within 28 days postpartum, or lactating.
16. Patients who are considered inappropriate as subjects for this clinical study by the clinical research director or registered dentist for other reasons.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation about pain with VAS

Secondary Outcome Measures

Name	Time	Method
Evaluation about lesion size with X-ray