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Active, Not Recruiting

NCT Number: NCT06482593

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Apical Periodontitis Jaw Diseases Mouth Diseases Periapical Diseases Periapical Periodontitis Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dental Clinics of the University College of Colombia

Bogotá, Cundinamarca, 111711, Colombia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zinc-Oxide Eugenol Sealer

Drug

Zinc oxide-eugenol sealers have a slow setting time, shrinkage while setting, solubility, and can discolour tooth structure. This sealer group has an advantage in terms of antibacterial activity.It will absorb if extruded into the periradicular tissues.

AH-Plus Epoxy Resin Sealer

Drug

Dentsply AH Plus Root Canal Sealing Material is a two-component paste/paste root canal sealer based on epoxy-amine resin. The AH Plus sealer shows extremely low shrinkage making it a suitable choice of material to seal the root canal.

Bio-C Sealer

Drug

Bio-C® Sealer is a ready-to-use, bioceramic root canal sealer with biologically active ingredients to seal and heal the root canal space. Bio-C Sealer's mechanical and physical properties make it easy to manipulate and seal the canals, while its biological properties and high pH ensure safety and treatment success.

Other names: Bioceramic Sealer

Primary outcomes

  1. Volumetric Periapical Healing

    Time frame: Six months follow-up

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

Sponsors and collaborators

Lead sponsor

Institucion Universitaria Colegios de Colombia

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 1, 2024
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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