Clinical Efficacy of AH Plus Bioceramic Sealer

Ministry of Health, Kuwait

Status

Invitation-only

Conditions

Root Canal Infection

Periapical Periodontitis

Periapical Diseases

Treatments

Device: AH Plus Bioceramic Sealer

Device: AH Plus Sealer (resin-based)

Study type

Interventional

Funder types

Other

Identifiers

NCT05763420

2291

Details and patient eligibility

About

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.

Full description

Calcium silicate sealers are used in endodontics because of their biocompatibility, bioactive properties and fluid-tight seal that forms a chemical bond with root canal dentine. In vitro and retrospective studies have shown promising results. However, to date, there is a lack of prospective and well-controlled studies.

Aims and objectives:

To compare the clinical outcome of SBO with WVC in primary root canal treatment.
To compare the radiographic outcome of SBO with WVC in primary root canal treatment using periapical radiography (PA) and cone-beam computed tomography (CBCT).

Materials and Methods:

Patients who are referred for primary root canal treatment of molar teeth at Jaber Al-Ahmed Dental Center and fulfil the inclusion/exclusion criteria of the study will be included.
Informed consent will be obtained from all participants.
Preoperative PA and CBCT scans will be taken.
Upon completion of root canal instrumentation, the participants will be randomly allocated to either Group A: SBO or Group B: WVC. The participants will be blinded to the type of treatment received and the clinician will only be informed of the obturation method once the canals are ready for obturation.
All teeth will then be restored definitively.
The participants will be recalled after 1 year for clinical and radiographic assessment using PA and CBCT scans.
The participants will then be followed-up annually for up to 4 years.
Statistical analysis will be performed.
The design of the study will conform to the CONSORT statement.
The study will be conducted in accordance with the Declaration of Helsinki, and ethical approval has been granted by the local health authority (ID: 2291).

Statistical and Analytical Plans:

Sample size estimation for the treatment outcome was performed using PASS 2019 computer software, utilizing information from previous studies on healing outcome after primary root canal treatment. For a two independent-samples t-test of proportions, at a power of 80% and a 5% significance level for a two-tailed test, detecting a 10% difference in healing rate required a sample size of 148 teeth. Adjusting for a dropout rate of 30%, the required sample size will be 212 teeth.

The outcome at a specific time-point (12 months) will be a primary response variable in analysis. Outcome will be the dependent variable in logistic regression models with different predictor variables: age, sex, periapical status, preoperative pain, patency, apical size, root filling quality and sealer used. Two-way interactions between factors will also be assessed.

Expected outcome (Null Hypothesis):

No significant difference will be found between the two groups in clinical and radiographic outcomes.

Enrollment

212 estimated patients

Sex

All

Ages

21 to 65 years old

Volunteers

Accepts Healthy Volunteers

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