Periapical Healing in Response to Endodontically Treated Teeth With Different Sealing Cement

Institucion Universitaria Colegios de Colombia

Status and phase: Active, not recruiting; Phase 4

Conditions: Apical Periodontitis

Treatments: Drug: Zinc-Oxide Eugenol Sealer; Drug: AH-Plus Epoxy Resin Sealer; Drug: Bio-C Sealer

Study type: Interventional

Funder types: Other

Identifiers

NCT06482593

NRios_Periapical-Healing_CBCT

Details and patient eligibility

About

The goal of this clinical trial is to conduct an in vivo study that allows to compare the periapical healing process of 3 different sealing cements through CBCT, as well as implement the evaluation of these lesions through volumetric measurements to provide high-level scientific information and thus have the possibility of being applied in the clinical dental practice, in patients attending UNICOC dental clinics between 2023 and 2024. The main question it aims to answer is:

• Do bioceramic sealer promote faster periapical healing due to their better sealing capacity and high bio-compatibility?
• Are there no differences between endodontic sealers in terms of apical healing? If there is a comparison group: Researchers will compare Bio-C Sealer (Bioceramic sealer) Zinc-oxide eugenol sealer and AH-Plus epoxy resin sealer to evaluate periapical healing after a six months follow-up of conventional endodontic therapy.

Coronal permanent restoration must be performed no later than 15 days after endodontic therapy.

Enrollment: 72 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18 to 60
• Patients systemically healthy (ASA I)
• Patients that require endodontic therapy for single-rooted teeth with pulp necrosis and apical periodontitis (AP).
• CBCT PAI periapical index score 3 or above, with no symptoms at the time of appointment.

Exclusion criteria

• Exclusion criteria included other than ASA-1 classification
• Patients with Perforated cortical plates at cbct analysis
• Premature permanent teeth
• Patients with Endodontic-periodontic lesions, dystrophic calcifications, more than 20° root curvature
• Pregnancy or lactation
• Root fracture cases
• Use of analgesics within 12-24 hours root canal therapy and patients with endodontic abscess.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 3 patient groups

Groupe 1: ZOE-based sealant

Active Comparator group

Description:

ZOE-based sealant (GROSS-MAN, PROQUIDENT, COL)

Treatment:

Drug: Zinc-Oxide Eugenol Sealer

Groupe 2: AH-Plus Epoxy Resin Sealer

Active Comparator group

Description:

Epoxy resin-based sealant (AH Plus, Dentsply DeTrey, Konstanz, Germany)

Treatment:

Drug: AH-Plus Epoxy Resin Sealer

Groupe 3: Bio-C Sealer

Experimental group

Description:

Bioceramic sealer (Bio-C Sealer, ANGELUS, BRA)

Treatment:

Drug: Bio-C Sealer