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

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

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1062230093
Enrollment
60
Registered
2024-01-22
Start date
2024-12-05
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

apical periodontitis apical periodontitis

Interventions

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

Sponsors

Saito Noriko
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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 perforations that make tooth preservation impossible 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

Design outcomes

Primary

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

Secondary

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

Contacts

Public ContactNoriko Saito

Hiroshima University Hospital

r14saito@hiroshima-u.ac.jp+81-82-257-5656

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026