Apical PeriodontitisPhase 4NCT06482593

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

A Phase 4 study testing Zinc-Oxide Eugenol Sealer, AH-Plus Epoxy Resin Sealer and Bio-C Sealer in people with Apical Periodontitis, run by Institucion Universitaria Colegios de Colombia at 1 site in Colombia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Apical Periodontitis
What is being tested?: Zinc-Oxide Eugenol Sealer, AH-Plus Epoxy Resin Sealer and Bio-C Sealer
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteColombia
Study dates: 1 Aug 2023to 30 Sep 2024
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Colombia1 site

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

Other trials in Colombia

About this study

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

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.

Conditions: Apical Periodontitis
Being tested: Zinc-Oxide Eugenol Sealer, AH-Plus Epoxy Resin Sealer, Bio-C Sealer
Keywords: Clinical Trial, Endodontic Sealer, Periapical healing
Medical subject headings: Periapical Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.
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.
Bio-C SealerDrug
Also called Bioceramic 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.

Study groups in NCT06482593
Study group	Role	What they receive
Groupe 1: ZOE-based sealant	Active comparator	ZOE-based sealant (GROSS-MAN, PROQUIDENT, COL) Receives: Drug: Zinc-Oxide Eugenol Sealer
Groupe 2: AH-Plus Epoxy Resin Sealer	Active comparator	Epoxy resin-based sealant (AH Plus, Dentsply DeTrey, Konstanz, Germany) Receives: Drug: AH-Plus Epoxy Resin Sealer
Groupe 3: Bio-C Sealer	Experimental	Bioceramic sealer (Bio-C Sealer, ANGELUS, BRA) Receives: Drug: Bio-C Sealer

What is being measured

The primary outcome is the main question the study is designed to answer.

Volumetric Periapical Healing
Changes of the three-dimensional volume of the periapical lesion of endodontic origin
Measured: Six months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202330 Sep 2024

First posted1 Jul 2024
Study start1 Aug 2023
Primary completion31 Mar 2024
Study completion30 Sep 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for Apical PeriodontitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06482593
Sponsor's protocol ID: NRios_Periapical-Healing_CBCT
Status last verified: Jul 2024
First submitted: 25 Jun 2024
Last updated: 9 Jul 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 33540711
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.
PubMed 29069143
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.
PubMed 19121066
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.
PubMed 33146332
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.
PubMed 28607360
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.
PubMed 16215261
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.
PubMed 16584489
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.
PubMed 31367101
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.
PubMed 21779066
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.
PubMed 31815132
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.
PubMed 32213767
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.
PubMed 3248573
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.
PubMed 33378579
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.
PubMed 30410540
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.
PubMed 28707526

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Apical Periodontitis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Periapical Healing in Response to Endodontically Treated Teeth With Different Sealing Cements: An in Vivo Study With CBCT
ClinicalTrials.gov ID: NCT06482593
Acronym / sponsor ID: NRios_Periapical-Healing_CBCT
Conditions: Apical Periodontitis
Keywords: Clinical Trial, Endodontic Sealer, Periapical healing
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 72 participants (actual)
Lead sponsor: Institucion Universitaria Colegios de ColombiaUniversity, hospital or other
Study start: 1 Aug 2023 (actual)
Primary completion: 31 Mar 2024 (actual)
Study completion: 30 Sep 2024 (estimated)
First posted: 1 Jul 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Groupe 1: ZOE-based sealant	Active comparator	Drug: Zinc-Oxide Eugenol SealerZOE-based sealant (GROSS-MAN, PROQUIDENT, COL)
Groupe 2: AH-Plus Epoxy Resin Sealer	Active comparator	Drug: AH-Plus Epoxy Resin SealerEpoxy resin-based sealant (AH Plus, Dentsply DeTrey, Konstanz, Germany)
Groupe 3: Bio-C Sealer	Experimental	Drug: Bio-C SealerBioceramic sealer (Bio-C Sealer, ANGELUS, BRA)

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Zinc-Oxide Eugenol SealerZinc 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.	Drug	Groupe 1: ZOE-based sealant
AH-Plus Epoxy Resin SealerDentsply 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.	Drug	Groupe 2: AH-Plus Epoxy Resin Sealer
Bio-C SealerAlso: Bioceramic SealerBio-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.	Drug	Groupe 3: Bio-C Sealer

Primary outcome

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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
Background: PubMed 33540711Galler 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.
Background: PubMed 29069143Holland 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.
Background: PubMed 19121066Fukada 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.
Background: PubMed 33146332Neves 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.
Background: PubMed 28607360Yoneda 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.
Background: PubMed 16215261Schneeweis 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.
Background: PubMed 16584489Nair 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.
Background: PubMed 31367101Vishwanath 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.
Background: PubMed 21779066Shanahan 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.
Background: PubMed 31815132Pereira 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.
Background: PubMed 32213767Komabayashi 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.
Background: PubMed 3248573Eriksen 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Volumetric Periapical Healing (time frame: Six months follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06482593, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024; AzTrials last refreshed its copy on 1 Nov 2026.