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Evaluation of Bone Healing After Obturation With Dia-Root Bio Sealer (Calcium Silicate-based Sealer CSBS) Using Three Obturation Techniques (CSBS)

4. juli 2026 opdateret af: Omnia Saber, Ain Shams University

Evaluation of New Heat-Resistant Calcium Silicate- Based Sealer Using Different Obturation Techniques (In-Vitro and In-Vivo Study)

The study aims to evaluate the efficiency of using a Calcium silicate-based sealer (CSBS) with different obturation techniques in treating root canals with apical periodontitis in single visit.

Evaluating:

  1. Postoperative healing.
  2. Preoperative, postoperative pain and frequency of analgesic intake.

Studieoversigt

Status

Suspenderet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Evaluation of Dia-Root Bio Sealer (CSBS) using the three known obturation techniques; Single cone (SC) technique, Warm vertical compaction (WVC) technique, and Cold lateral compaction (CLC) technique.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

63

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Egypten
      • Cairo, Egypten
        • Faculty of Dentistry, Ain Shams University

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

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Medical condition: Medically free patients.
  • Age: Ranging from 20-50 years old
  • Gender: Male and female patients
  • Teeth: Patients with mandibular permanent mature molar(s) diagnosed with necrotic pulps and with apical periodontitis (asymptomatic, symptomatic apical periodontitis, or chronic periapical abscess), with at least one of the roots showing radiographic evidence of periapical lesion.
  • Preoperative radiographic (CBCT) lesion size should range from 2 - 4 mm.
  • Patients who fulfill these criteria, agree to participate, and sign the informed consent

Exclusion Criteria:

  • Participants with generalized periodontal disease, and those who are pregnant, breastfeeding, or have any systemic disease.
  • Teeth diagnosed with immature apices, root resorption, or non-restorable.
  • Patients in which the clinical assessment necessitates multiple-visits treatment, such as those with signs and symptoms of acute or diffuse infection.
  • Patients who had pre-treatment antibiotic therapy or analgesics and within 7 days.
  • Patients who fail to complete their final restoration postoperatively.
  • Patients who will refuse to sign the informed consent.
  • Root canals requiring apical preparation larger the #40.

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Single cone (SC) technique group
Conventional Root canal treatment followed by obturation with the Dia-Root Bio sealer using the Single cone technique
Enhed: Dia-Root Bio Sealer
The sealer will be delivered in the canals with the provided intracanal tips inserted three millimeters from the WL and back filling until the orifice. The pre-fitted master cone will be inserted with slight up and down motion before reaching the WL.
Andre navne:
  • Calcium silicate-based sealer
  • CSBS
  • MTA-based bioceramic root canal sealer
Procedure: Single cone (SC) Obturation technique
Filling the prepared root canal with the master cone and the CSBS. Then cutting the excess gutta percha from the root canal orifice
Andre navne:
  • Root canal compaction
  • Root filling techniques
Eksperimentel: Warm vertical compaction (WVC) technique group
Conventional Root canal treatment followed by obturation with the Dia-Root Bio sealer using the warm vertical compaction technique
Enhed: Dia-Root Bio Sealer
The sealer will be delivered in the canals with the provided intracanal tips inserted three millimeters from the WL and back filling until the orifice. The pre-fitted master cone will be inserted with slight up and down motion before reaching the WL.
Andre navne:
  • Calcium silicate-based sealer
  • CSBS
  • MTA-based bioceramic root canal sealer
Procedure: Warm Vertical compaction (WVC) technique
After placing the CSBS intside the RC, the cone will be packed down till 4 mm from the apex for 4 seconds cycles. Then the apical GP will be condensed using pluggers previously fitted inside the canal. Canals will be backfilled with 180C temperature setting. The tip will be placed into the root canal against the apical gutta-percha for 5 s before extruding the gutta-percha on increments. The middle and coronal thirds will be condensed using pre-fitted pluggers.
Andre navne:
  • Root canal filling
  • Root canal obturation
Aktiv komparator: Cold lateral compaction (CLC) technique group
Conventional Root canal treatment followed by obturation with the Dia-Root Bio sealer using the cold lateral compaction technique
Enhed: Dia-Root Bio Sealer
The sealer will be delivered in the canals with the provided intracanal tips inserted three millimeters from the WL and back filling until the orifice. The pre-fitted master cone will be inserted with slight up and down motion before reaching the WL.
Andre navne:
  • Calcium silicate-based sealer
  • CSBS
  • MTA-based bioceramic root canal sealer
Procedure: Cold lateral condensation (CLC) technique
After placing the CSBS inside the root canal, the master GP cone will be laterally condensed with a pre-selected spreader inserted 2-4 mm from the WL and accessory GP cone will be placed in the provided space by the spreader. This process will be repeated until 1 mm from the canal orifice. Excess GP will be cut at the orifice with a heat carrier and lightly packed vertically with a plugger.
Andre navne:
  • Root canal filling
  • Root canal obturation
  • Gold standard root canal filling technique

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Success of healing and healing rate of the periapical lesion after one year
Tidsramme: 6 and 12 months postoperatively
Periapical bone healing will be evaluated using Cone Beam Computed Tomography (CBCT) images scored according to the CBCT Periapical Index (CBCT-PAI). Success is defined as a CBCT-PAI score of 0 (healthy) or a significant reduction in the volumetric size of the periapical radiolucency compared to the preoperative baseline
6 and 12 months postoperatively

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Postoperative Pain Intensity
Tidsramme: Preoperative (Baseline) and 72 hours postoperative
The change in patient-reported pain intensity from baseline. Pain is evaluated using a 0 to 100 mm Visual Analog Scale (VAS), where 0 represents 'no pain' and 100 represents 'the worst imaginable pain' Patients will be asked not to use analgesic medication after treatment until needed. If necessary, the patient will be instructed to record pain score before analgesic administration and record the dose and frequency of intake (by hour) of the analgesic and to submit this information after 72 h.
Preoperative (Baseline) and 72 hours postoperative

Samarbejdspartnere og efterforskere

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

Sponsor

Ain Shams University

Efterforskere

  • Studieleder: Mohammed M Nagy, Professor, Faculty of Dentistry, Ain Shams University
  • Studiestol: Sara H Fahmy, Lecturer of Endodontics, Faculty of Dentistry, Ain Shams University

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 (Faktiske)

29. juli 2025

Primær færdiggørelse (Anslået)

1. december 2028

Studieafslutning (Anslået)

1. december 2028

Datoer for studieregistrering

Først indsendt

29. juni 2026

Først indsendt, der opfyldte QC-kriterier

29. juni 2026

Først opslået (Faktiske)

6. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 71226

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med Periapikal parodontitis

Kliniske forsøg med Dia-Root Bio Sealer

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Placeringer

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