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Japanese

Aug. 01, 2024

July. 08, 2025

jRCTs052240103

Randomized controlled trial comparing root canal filling using resin sealer without gutta-percha point to using conventional technique of root canal filling. (MSSP RCT )

MSSP RCT (MSSP RCT )

Takahashi Yusuke

Osaka University Dental Hospital

1-8 Yamadaoka, Suita, Osaka

+81-6-6879-2927

takahashi.yusuke.dent@osaka-u.ac.jp

Takahashi Yusuke

Osaka University Dental Hospital

1-8 Yamadaoka, Suita, Osaka

+81-6-6879-2927

takahashi.yusuke.dent@osaka-u.ac.jp

Recruiting

Aug. 01, 2024

384

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

(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.

(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.

18age 0month 0week old over
90age 0month 0week old not

Both

irreversible pulpitis
pulp necrosis
Apical periodontitis

group configuration

Irreversible pulpitis, Pulp necrosis, Apical periodontitis

Evaluation of periodontal tissue at the root apex using CBCT and clinical symptoms

(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

Sun Medical Company, Ltd,
Not applicable
National Cerebral and Cardiovascular Center Clinical Research Review Board
6-1 Kishibeshinmachi, Suita, Osaka

+81-6-6170-1070

crb-office@ncvc.go.jp
Approval

Feb. 13, 2024

No

None

History of Changes

No Publication date
3 July. 08, 2025 (this page) Changes
2 Aug. 14, 2024 Detail Changes
1 Aug. 01, 2024 Detail