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Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer

3. november 2026 opdateret af: University Ghent

Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer: a Randomized Clinical Trial

When the nerve inside a tooth becomes inflamed, it can cause severe pain and may eventually lead to the death of the nerve. In these cases, root canal treatment is necessary to remove the inflamed nerve or to treat or prevent infection associated with a dead nerve.

During root canal treatment, the root canals are carefully cleaned and then filled. This is usually done using a flexible, rubber-like material called gutta-percha, combined with a special dental cement known as a root canal sealer.

Different types of root canal sealers are available, including AH Plus and BioRoot Flow. The aim of this study is to compare these two sealers to determine whether there are differences in pain experienced after treatment and in treatment success, assessed during follow-up visits after 1 and 2 years.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

138

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Written informed consent obtained
  • Age: ≥ 18 years
  • ASA I, II & III
  • Permanent single or multi-rooted mature tooth requiring root-canal treatment
  • Diagnosis: (a)symptomatic irreversible pulpitis or pulp necrosis, with or without apical periodontitis or initially treated

Exclusion Criteria:

  • Unlikely to be able to comply with the study procedures, as judged by the investigator
  • Immature permanent teeth
  • Teeth presenting with aberrant root canal anatomy (e.g., perforation, resorption or canal calcification)
  • Patients presenting with pain in another area and/or tooth of the oral cavity
  • Patient suffering from uncontrolled active periodontitis
  • Patients who took medication that could alter pain perception (e.g. analgesics) within at least 12 h before treatment
  • Known or suspected current malignancy
  • History of chemotherapy within 5 years prior to study or radiation in the head and neck region
  • History of other metabolic bone diseases
  • Endodontic retreatment (ortho-and retrograde), reversible pulpitis

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: A calcium silicate-based sealer
Enhed: A calcium silicate-based sealer

Root canal obturation is performed using the single-cone technique, in which a gutta-percha cone is inserted into the root canal in combination with a calcium silicate-based sealer: BioRoot Flow
Eksperimentel: An epoxy resin- based sealer
Enhed: An epoxy resin- based sealer

Root canal obturation is performed using the single-cone technique, in which a gutta-percha cone is inserted into the root canal in combination with an epoxy resin-based sealer: AH Plus Jet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Post-operative pain
Tidsramme: 6 hours, 24 hours, 48 hours, 72 hours and 7 days after treatment

The post-operative pain is scored with the Visual Analogue Scale (VAS). Patients are asked to fill out a pain diary 6 hours, 24 hours, 48 hours, 72 hours and 7 days after treatment with a pain score on the Visual Analogue Scale. They mark the level of pain on a scale from 0 to 10. Higher scores indicate greater pain intensity.
6 hours, 24 hours, 48 hours, 72 hours and 7 days after treatment
Treatment outcome
Tidsramme: up to 2 years following treatment

The 1 and 2 year success rates are determined using a combination of radiographic and clinical outcome measures.

  • Clinical: The absence of pain, tenderness, swelling and a sinus tract)
  • Radiographic: The pre-operative and recall periapical radiographs are assessed qualitatively by means of the Periapical Index (PAI) and quantitatively by means of surface area measurements of the APs on periapical radiographs.

The two aforementioned outcomes will be combined to determine overall treatment success, which will be classified into three categories:

  • Strict success criteria (healed): Absence of clinical signs and/or radiographic evidence of complete resolution or the absence of a periapical radiolucency.
  • Loose success criteria (healing): Absence of clinical signs and a lower PAI-score/ smaller surface of the lesion compared to the pre-operative radiograph.
  • Failure (non-healing): Presence of clinical signs or unchanged/increased PAI-score (or surface of the lesion) at follow-up.
up to 2 years following treatment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Quality of obturation
Tidsramme: Immediately after treatment

The root canal obturation is evaluated on peri-apical radiograph on the presence of voids. First is stated if a void was present (Yes/No). If so, a distinction is made whether the void was smaller or bigger than 1 mm.
Immediately after treatment
Sealer extrusion
Tidsramme: Immediately after treatment

The presence of sealer extrusion beyond the apical foramen is evaluated as a binary outcome (Yes/No).
Immediately after treatment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Ghent

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. november 2026

Primær færdiggørelse (Anslået)

1. august 2029

Studieafslutning (Anslået)

1. august 2029

Datoer for studieregistrering

Først indsendt

20. oktober 2026

Først indsendt, der opfyldte QC-kriterier

3. november 2026

Først opslået (Faktiske)

6. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. november 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ONZ-2026-0209

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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