Clinical Efficacy of AH Plus Bioceramic Sealer (NCT05763420) | Clinical Trial Compass
By InvitationNot Applicable
Clinical Efficacy of AH Plus Bioceramic Sealer
Kuwait136 participantsStarted 2023-08-07
Plain-language summary
The goal of this clinical trial is to assess the efficacy and outcome of sealer-based obturation (SBO) using a new calcium silicate sealer in comparison with warm vertical compaction (WVC) using a resin-based sealer, which is the current gold standard.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Participants must be 18-65 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 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 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
What they're measuring
1
Assessment of radiographic healing with cone beam computed tomography (CBCT) scans using Estrela's PAI (periapical index)
Timeframe: Change from baseline periapical lesion size at 12 months
2
Assessment of clinical outcome by assessing the resolution/persistence/development of clinical signs and symptoms