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

JRCT ID: jRCT1062230093

Registered date:22/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: apical periodontitis
• Date of first enrollment: 22/01/2024
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Root canal filling with Bio-Sea Sealer and gutta-perch

Outcome(s)

• Primary Outcome: Percentage of patients with reduced or eliminated periapical bone defect image area calculated from dental radiographs images.
• Secondary Outcome: Evaluation of periapical tissue healing tendency using dental radiographs based on the PAI score

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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. whose tooth has a single root canal confirmed after the start of infected root canal treatment
6. those who have undergone re-root canal treatment
7. whose clinical symptoms have resolved after root canal treatment and the results of the root canal bacterial culture test have been confirmed negative.

Exclude 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 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

Related Information

• Primary Sponsor: Saito Noriko