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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 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Egypten
    • Asyut Governorate
      • Asyut, Asyut Governorate, Egypten
        • Faculty of dentistry, Assiut university
        • Kontakt:

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:

  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

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
Aktiv komparator: Traditional group
In this group traditional access cavity and canal preparations is done
Procedure: 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
Procedure: Root canal treatment
Root canal treatment is done

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

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

Sponsor

Mohamed Ashraf Abdeen

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)

23. juli 2026

Primær færdiggørelse (Anslået)

1. september 2027

Studieafslutning (Anslået)

1. september 2027

Datoer for studieregistrering

Først indsendt

22. juli 2026

Først indsendt, der opfyldte QC-kriterier

8. august 2026

Først opslået (Faktiske)

13. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. august 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Minimally invasive endo

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

All collected IPD

IPD-delingstidsramme

Beginning after publication of results and ending after 2 years

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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