NCT06482593

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

July 9, 2024

Status Verified

July 1, 2024

Enrollment Period

8 months

First QC Date

June 25, 2024

Last Update Submit

July 6, 2024

Conditions

Apical Periodontitis

Keywords

Clinical TrialEndodontic SealerPeriapical healing

Outcome Measures

Primary Outcomes (1)

  • Volumetric Periapical Healing

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

    Six months follow-up

Study Arms (3)

Groupe 1: ZOE-based sealant

ACTIVE COMPARATOR

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

Drug: Zinc-Oxide Eugenol Sealer

Groupe 2: AH-Plus Epoxy Resin Sealer

ACTIVE COMPARATOR

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

Drug: AH-Plus Epoxy Resin Sealer

Groupe 3: Bio-C Sealer

EXPERIMENTAL

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

Drug: Bio-C Sealer

Interventions

Zinc-Oxide Eugenol SealerDRUG

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.

Groupe 1: ZOE-based sealant
AH-Plus Epoxy Resin SealerDRUG

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.

Groupe 2: AH-Plus Epoxy Resin Sealer
Bio-C SealerDRUG

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.

Also known as: Bioceramic Sealer
Groupe 3: Bio-C Sealer

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dental Clinics of the University College of Colombia

Bogotá, Cundinamarca, 111711, Colombia

Location

Related Publications (16)

  • Galler KM, Weber M, Korkmaz Y, Widbiller M, Feuerer M. Inflammatory Response Mechanisms of the Dentine-Pulp Complex and the Periapical Tissues. Int J Mol Sci. 2021 Feb 2;22(3):1480. doi: 10.3390/ijms22031480.

    PMID: 33540711BACKGROUND

  • Holland R, Gomes JE Filho, Cintra LTA, Queiroz IOA, Estrela C. Factors affecting the periapical healing process of endodontically treated teeth. J Appl Oral Sci. 2017 Sep-Oct;25(5):465-476. doi: 10.1590/1678-7757-2016-0464.

    PMID: 29069143BACKGROUND

  • Fukada SY, Silva TA, Garlet GP, Rosa AL, da Silva JS, Cunha FQ. Factors involved in the T helper type 1 and type 2 cell commitment and osteoclast regulation in inflammatory apical diseases. Oral Microbiol Immunol. 2009 Feb;24(1):25-31. doi: 10.1111/j.1399-302X.2008.00469.x.

    PMID: 19121066BACKGROUND

  • Neves MAS, Provenzano JC, Fonseca SCL, Rodrigues RCV, Goncalves LS, Siqueira JF Jr, Rocas IN. Disinfection and outcome of root canal treatment using single-file or multifile systems and Ca(OH)2 medication. Braz Dent J. 2020 Sep-Oct;31(5):493-498. doi: 10.1590/0103-6440202003245.

    PMID: 33146332BACKGROUND

  • Yoneda N, Noiri Y, Matsui S, Kuremoto K, Maezono H, Ishimoto T, Nakano T, Ebisu S, Hayashi M. Development of a root canal treatment model in the rat. Sci Rep. 2017 Jun 12;7(1):3315. doi: 10.1038/s41598-017-03628-6.

    PMID: 28607360BACKGROUND

  • Schneeweis LA, Willard D, Milla ME. Functional dissection of osteoprotegerin and its interaction with receptor activator of NF-kappaB ligand. J Biol Chem. 2005 Dec 16;280(50):41155-64. doi: 10.1074/jbc.M506366200. Epub 2005 Oct 7.

    PMID: 16215261BACKGROUND

  • Nair PN. On the causes of persistent apical periodontitis: a review. Int Endod J. 2006 Apr;39(4):249-81. doi: 10.1111/j.1365-2591.2006.01099.x.

    PMID: 16584489BACKGROUND

  • Vishwanath V, Rao HM. Gutta-percha in endodontics - A comprehensive review of material science. J Conserv Dent. 2019 May-Jun;22(3):216-222. doi: 10.4103/JCD.JCD_420_18.

    PMID: 31367101BACKGROUND

  • Shanahan DJ, Duncan HF. Root canal filling using Resilon: a review. Br Dent J. 2011 Jul 22;211(2):81-8. doi: 10.1038/sj.bdj.2011.573.

    PMID: 21779066BACKGROUND

  • Pereira TM, Piva E, Cuevas-Suarez CE, Ricci Volpato LE, Neto MDSDS, Pivatto K, Pecora JD, Borges AH. Experimental Resin-Based Monoblock Endodontic Obturation System. Biomed Res Int. 2019 Nov 7;2019:3512606. doi: 10.1155/2019/3512606. eCollection 2019.

    PMID: 31815132BACKGROUND

  • Komabayashi T, Colmenar D, Cvach N, Bhat A, Primus C, Imai Y. Comprehensive review of current endodontic sealers. Dent Mater J. 2020 Sep 29;39(5):703-720. doi: 10.4012/dmj.2019-288. Epub 2020 Mar 24.

    PMID: 32213767BACKGROUND

  • Eriksen HM, Orstavik D, Kerekes K. Healing of apical periodontitis after endodontic treatment using three different root canal sealers. Endod Dent Traumatol. 1988 Jun;4(3):114-7. doi: 10.1111/j.1600-9657.1988.tb00307.x. No abstract available.

    PMID: 3248573BACKGROUND

  • Tiburcio-Machado CS, Michelon C, Zanatta FB, Gomes MS, Marin JA, Bier CA. The global prevalence of apical periodontitis: a systematic review and meta-analysis. Int Endod J. 2021 May;54(5):712-735. doi: 10.1111/iej.13467. Epub 2021 Jan 22.

    PMID: 33378579BACKGROUND

  • Lo Giudice R, Nicita F, Puleio F, Alibrandi A, Cervino G, Lizio AS, Pantaleo G. Accuracy of Periapical Radiography and CBCT in Endodontic Evaluation. Int J Dent. 2018 Oct 16;2018:2514243. doi: 10.1155/2018/2514243. eCollection 2018.

    PMID: 30410540BACKGROUND

  • Kruse C, Spin-Neto R, Reibel J, Wenzel A, Kirkevang LL. Diagnostic validity of periapical radiography and CBCT for assessing periapical lesions that persist after endodontic surgery. Dentomaxillofac Radiol. 2017 Oct;46(7):20170210. doi: 10.1259/dmfr.20170210. Epub 2017 Jul 14.

    PMID: 28707526BACKGROUND

  • Jalali P, Riccobono J, Augsburger RA, Tahmasbi-Arashlow M. Radiographic patterns of periosteal bone reactions associated with endodontic lesions. Restor Dent Endod. 2023 Jun 8;48(3):e23. doi: 10.5395/rde.2023.48.e23. eCollection 2023 Aug.

    PMID: 37675448BACKGROUND

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dentistry, Specialization in Endodontics, Master in Sciences

Study Record Dates

First Submitted

June 25, 2024

First Posted

July 1, 2024

Study Start

August 1, 2023

Primary Completion

March 31, 2024

Study Completion

September 30, 2024

Last Updated

July 9, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

CO(1)