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Impact of Minimally Invasive Endodontic Treatment on the Prognosis of Mandibular Permanent Molars With Necrotic Pulp and Apical Periodontitis

8. august 2026 oppdatert av: Mohamed Ashraf Abdeen
Statement of the problem: The effectiveness of minimally invasive endodontic treatments in managing necrotic pulp with apical periodontitis remains understudied. Aim of the study: This research aims to evaluate the outcomes of minimally invasive versus traditional root canal treatments in patients with necrotic pulp associated with apical periodontitis. Material and methods: sixty healthy patients of both genders aged from 20 to 50 years old suffering from necrotic pulp associated with apical periodontitis in their lower first molars with four root canals will be included in this study. The initial assessment will include a preoperative CBCT scan. Participants will be randomly assigned according to the type of endodontic treatment to two groups; a traditional treatment group (Trad); in which a traditional access cavity design and root canal preparation extending three sizes beyond the initial apical file using taper .04 rotary files will be accomplished and a minimally invasive group (MI) in which a conservative access cavity and a conservative root canal preparation up to #20/.04 will be performed. Both groups will receive an identical irrigation protocol during root canal instrumentation augmented with passive ultrasonic activation. Immediately following biomechanical preparation, the root canals will be filled with single cone obturation technique. Root canal disinfection will be evaluated using a culture method in which two bacterial samplings will be collected, one before and another after the biomechanical preparation. Patients will be monitored over 12 months, concluding with a follow-up CBCT scan to assess periapical healing. Data will be collected and statistically analyzed.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Fase 2
  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Egypt
    • Asyut Governorate
      • Asyut, Asyut Governorate, Egypt
        • Faculty of dentistry, Assiut university
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  1. Participants with free medical history (category: American Society of Anaesthesiologists class I) from either gender aged from 20 to 50 years old.
  2. Necrotic lower first molars with four root canals (two mesials and two distals).
  3. Teeth have a periapical radiolucency with a diameter of 2-4 mm in CBCT images.
  4. Teeth show root curvature of 10°-20° as described by Schnider.
  5. Participant that indicated for single visit root canal treatment.

Exclusion Criteria:

  1. Calcified or non-negotiatable teeth.
  2. Participants who cannot apply for the follow-up schedule.
  3. Teeth that show any signs of cracks or vertical root fractures.
  4. Teeth that show less than 50% of sound coronal tooth structure.
  5. Periodontally affected teeth.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Traditional group
In this group traditional access cavity and canal preparations is done
Fremgangsmåte: Root canal treatment
Root canal treatment is done
Aktiv komparator: Minimally invasive group
In this group conservative access cavity and minimally invasive root canal preparation is done
Fremgangsmåte: Root canal treatment
Root canal treatment is done

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Success rate
Tidsramme: 1 year follow up

A case is deemed successful if there is no clinical signs and symptoms of infection or inflammation and radiographic bone healing.

The success rate for each group will be determined by the ratio of successful cases to the total number of cases in that group.
1 year follow up

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Healing of periapical lesion
Tidsramme: 1 year
The change in the size of periapical radiolucencies will be assessed through a comparison of CBCT images taken preoperatively and at the 12-month follow-up. This evaluation will be conducted by two independent operators who are not aware of the treatment group assignments to ensure unbiased results.
1 year
Bacterial load
Tidsramme: Within 2 days after intervention

The bacterial levels within the root canals will be quantified at two critical stages of the treatment process:

S1: Immediately following the creation of the access cavity, prior to initiating any cleaning or shaping procedures. This step is crucial for determining the initial bacterial load present in the root canal system.

S2: Following irrigant activation. This measurement will provide insight into the efficacy of the cleaning and shaping procedures, as well as the irrigation protocol, in reducing the bacterial population within the canal. These bacterial samples will be collected using sterile a three size #15 paper points which will be inserted into the canals to absorb the canal contents. This method ensures a standardized approach to bacterial sampling at these specified stages of the treatment.
Within 2 days after intervention
Treatment duration
Tidsramme: During procedure
The total time taken to complete the treatment procedure, from the beginning of the access cavity preparation to the completion of obturation, will be meticulously recorded for each case.
During procedure
Iatrogenic errors
Tidsramme: During procedure
Any occurrences of iatrogenic errors, such as instrument separation, will be noted and recorded. This data will provide insight into the potential risks associated with each treatment approach.
During procedure

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Mohamed Ashraf Abdeen

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

23. juli 2026

Primær fullføring (Antatt)

1. september 2027

Studiet fullført (Antatt)

1. september 2027

Datoer for studieregistrering

Først innsendt

22. juli 2026

Først innsendt som oppfylte QC-kriteriene

8. august 2026

Først lagt ut (Faktiske)

13. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. august 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Minimally invasive endo

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

All collected IPD

IPD-delingstidsramme

Beginning after publication of results and ending after 2 years

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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