臨床研究等提出・公開システム

Evaluation of the efficacy Bio-C Sealer of during endodontic re-treatment.

Study of the efficacy of Bio-C Sealer in endodontic retreatment.

Saito Noriko

Hiroshima University Hospital

1-2-3,Kasumi,Minami-ku,Hiroshima-city,Hiroshima

r14saito@hiroshima-u.ac.jp

Saito Noriko

Hiroshima University Hospital

1-2-3,Kasumi,Minami-ku,Hiroshima-city,Hiroshima

+81-82-257-5656

r14saito@hiroshima-u.ac.jp

Recruiting

Jan. 22, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1. persons who are at least 18 years of age at the time of obtaining consent
2. who have given their written consent to participate in the study
3. who are able to visit the clinic for treatment and follow-up
4. who have had periapical bone resorption confirmed by dental radiographs prior to treatment
5. those who have undergone re-root canal treatment
6. whose clinical symptoms have resolved after root canal treatment and the results of the root canal bacterial culture test have been confirmed negative.

1. those with severe clenching of the teeth (clenching and bruxism)
2. those with root fractures.
3. those with periodontal-endodontic or endodontic-periodontal lesions.
4. those whose teeth under study have undergone perforation
5. persons with a history of hypersensitivity, such as rashes or dermatitis, to chemical substances, including raw materials of the material under study
6. women who are pregnant or possibly pregnant, lactating or wishing to become pregnant
7. who are participating or intend to participate in other clinical research studies during the period of their participation in this study
8. is deemed to interfere with, limit or confound the evaluation specific to the clinical research plan
9. the principal investigator(s) directly involved in this or any other clinical research, or any employee of the implementing healthcare organisation, or any family member of the principal investigator(s)
10. those whose clinical symptoms (spontaneous pain, bruxism, gingival swelling or redness, fistula) have not resolved despite standard root canal treatment
11. those whose clinical symptoms disappear after root canal treatment but the results of the root canal bacterial culture test do not become negative for more than six months
12. who have previously been enrolled in this study
13. who have periapical bone resorption contiguous to the root apex of multiple teeth on pre-treatment dental radiographs

Both

apical periodontitis

Root canal filling with Bio-Sea Sealer and gutta-perch

apical periodontitis

Bio-C Sealer

D010485

Percentage of patients with reduced or eliminated periapical bone defect image area calculated from dental radiographs images.

Evaluation of periapical tissue healing tendency using dental radiographs based on the PAI score

+81-82-257-1551

Jan. 16, 2024

none