MSSP RCT

JRCT ID: jRCTs052240103

Registered date:01/08/2024

Basic Information

• Recruitment status: Recruiting

Health condition(s) or Problem(s) studied

irreversible pulpitis
pulp necrosis
Apical periodontitis

• Date of first enrollment: 01/08/2024
• Target sample size: 384
• Study type: Interventional
• Intervention(s): group configuration

Outcome(s)

• Primary Outcome: Evaluation of periodontal tissue at the root apex using CBCT and clinical symptoms

Secondary Outcome

(1) Evaluation of treatment time
(2) Evaluation of periodontal tissue at the root apex using dental radiographs
(3) Obtaining VAS values
(4) Evaluation of periodontal pockets
(5) Horizontal percussion pain
(6) Degree of mobility
(7) Condition of gingiva corresponding to root apex

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 90age old
• Gender: Both

Include criteria

(1) Diagnosis of irreversible pulpitis, pulp necrosis, or apical periodontitis based on pulp and periodontal histology and imaging (dental radiographs and dental cone-beam CT).
(2) It has been determined that healing is possible by root canal treatment using the standard method.
(3) The patient is between 18 and 90 years of age at the time of consent and is capable of consenting.
(4) The patient's condition is expected to be stable for at least 12 months from the time consent is obtained.
(5) Written consent to participate in this study has been obtained from the patient.

Exclude criteria

(1) Has an allergy to raw materials used for root canal filling sealer.
(2) With horizontal or vertical root fracture.
(3) Perforation difficult to repair and removal of foreign body in root canal difficult to remove.
(4) Traffic between periodontal pocket and root canal lesion.
(5) History of root tip resection and intentional replantation.
(6) It is judged that normal root canal treatment is extremely difficult due to morphological reasons of the root canal, such as dens invaginatus.
(7) Patient has a deciduous tooth and a stenotic root canal, and the final magnification of root canal formation is #35 or less.
(8) Diagnosed with diabetes mellitus.
(9) Patients who are judged to be inappropriate as research subjects by the principal investigator or a sub investigator for other reasons.

Related Information

• Primary Sponsor: Takahashi Yusuke
• Secondary Sponsor: Hayashi Mikako
• Source(s) of Monetary Support: Sun Medical Company, Ltd,