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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06482593
Enrollment
72
Registered
2024-07-01
Start date
2023-08-01
Completion date
2024-09-30
Last updated
2024-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apical Periodontitis

Keywords

Clinical Trial, Endodontic Sealer, Periapical healing

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.

Interventions

DRUGZinc-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.

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 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.

Sponsors

Institucion Universitaria Colegios de Colombia
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

*

Design outcomes

Primary

MeasureTime frameDescription
Volumetric Periapical HealingSix months follow-upChanges of the three-dimensional volume of the periapical lesion of endodontic origin

Countries

Colombia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026