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

July 6, 2024 updated by: Nestor Raúl Rios Osorio, Institucion Universitaria Colegios de Colombia

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Cundinamarca
      • Bogotá, Cundinamarca, Colombia, 111711
        • Dental Clinics of the University College of Colombia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Groupe 1: ZOE-based sealant
ZOE-based sealant (GROSS-MAN, PROQUIDENT, COL)
Drug: Zinc-Oxide Eugenol Sealer
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.
Active Comparator: Groupe 2: AH-Plus Epoxy Resin Sealer
Epoxy resin-based sealant (AH Plus, Dentsply DeTrey, Konstanz, Germany)
Drug: AH-Plus Epoxy Resin Sealer
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.
Experimental: Groupe 3: Bio-C Sealer
Bioceramic sealer (Bio-C Sealer, ANGELUS, BRA)
Drug: Bio-C Sealer
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volumetric Periapical Healing
Time Frame: Six months follow-up
Changes of the three-dimensional volume of the periapical lesion of endodontic origin
Six months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institucion Universitaria Colegios de Colombia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Actual)

March 31, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

June 25, 2024

First Submitted That Met QC Criteria

June 25, 2024

First Posted (Actual)

July 1, 2024

Study Record Updates

Last Update Posted (Actual)

July 9, 2024

Last Update Submitted That Met QC Criteria

July 6, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRios_Periapical-Healing_CBCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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