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Clinical Trials/NCT06482593
NCT06482593
Active, Not Recruiting
Phase 4

Periapical Healing in Response to Endodontically Treated Teeth With Different Sealing Cements: An in Vivo Study With CBCT

Institucion Universitaria Colegios de Colombia1 site in 1 country72 target enrollmentAugust 1, 2023

Overview

Phase
Phase 4
Intervention
Zinc-Oxide Eugenol Sealer
Conditions
Apical Periodontitis
Sponsor
Institucion Universitaria Colegios de Colombia
Enrollment
72
Locations
1
Primary Endpoint
Volumetric Periapical Healing
Status
Active, Not Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2023
End Date
September 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nestor Raúl Rios Osorio

Dentistry, Specialization in Endodontics, Master in Sciences

Institucion Universitaria Colegios de Colombia

Eligibility Criteria

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.

Arms & Interventions

Groupe 1: ZOE-based sealant

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

Intervention: Zinc-Oxide Eugenol Sealer

Groupe 2: AH-Plus Epoxy Resin Sealer

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

Intervention: AH-Plus Epoxy Resin Sealer

Groupe 3: Bio-C Sealer

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

Intervention: Bio-C Sealer

Outcomes

Primary Outcomes

Volumetric Periapical Healing

Time Frame: Six months follow-up

Changes of the three-dimensional volume of the periapical lesion of endodontic origin

Study Sites (1)

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