Clinical Efficacy of AH Plus Bioceramic Sealer

Launched by MINISTRY OF HEALTH, KUWAIT · Mar 8, 2023

Keywords

ClinConnect Summary

This study is testing two ways to seal the inside of a tooth after root canal treatment in adult molars. One method uses a calcium-silicate “bioceramic” sealer (SBO with AH Plus Bioceramic Sealer) and the other uses a traditional resin-based sealer with warm vertical compaction (WVC with AH Plus Sealer). Participants are randomly assigned to one of the two methods, and both patients and most study staff are unaware of which treatment is used to keep results fair. The researchers will look at healing on 12-month imaging (CBCT scans) and at 12-month clinical signs (like pain or swelling) to see how well each method works. About 212 teeth will be studied.

To join, people should be 21–65 years old, in generally good health (ASA I or II), able to consent, have good oral hygiene, and need primary root canal treatment on a first molar that can be restored. Exclusions include pregnancy, advanced gum disease, certain dental problems, or teeth with complicated conditions. Participants will have preoperative X-rays and CBCT, then undergo standard root canal treatment with the assigned sealing method, followed by clinical checks and imaging at 1 year and then yearly for up to 4 years. The study is being conducted in Kuwait and is not yet reporting results; recruitment is ongoing with completion expected in 2026.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants must be 21-65 years of age at the time of recruitment
• • Participants must have a classification of I or II on the American Society of Anesthesiologists (ASA) physical status classification system
• • Participants must not have known allergies to any materials used in the study
• • Participants must agree to participate in the study by signing a consent form
• • Participants must have good oral hygiene
• • Maxillary and mandibular first permanent molar teeth that require primary root canal treatment will be included
• • The teeth must be restorable and have fully formed roots with no advanced periodontal disease
• Exclusion Criteria:
• • ASA classification of III or more
• • Pregnant or breastfeeding women
• • Patients who are unable to give consent
• • Patients who have advanced periodontal disease or teeth with more than 5mm probing
• • Anterior, premolar and second/third molar teeth
• • Teeth whose apices were over-enlarged at the time of pulp extirpation
• • Teeth with broken instruments
• • Teeth with blocked or non-negotiable canals
• • Teeth with iatrogenic perforations
• • Teeth with incomplete root formation
• • Teeth with internal or external root resorption
• • Teeth that have a poor restorative prognosis
• • Teeth that require posts or extensive prosthetic rehabilitation
• • Teeth with cracks
• • Teeth that have been previously root-filled