NCT07762248

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
12mo left

Started Jul 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress18%
Jul 2026Sep 2027

First Submitted

Initial submission to the registry

July 22, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

July 23, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 13, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

August 13, 2026

Status Verified

July 1, 2026

Enrollment Period

1.1 years

First QC Date

July 22, 2026

Last Update Submit

August 8, 2026

Conditions

Necrotic Mandibular MolarsApical Periodontitis

Keywords

Minimally invasive endodontics

Outcome Measures

Primary Outcomes (1)

  • Success rate

    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

Secondary Outcomes (4)

  • Healing of periapical lesion

    1 year

  • Bacterial load

    Within 2 days after intervention

  • Treatment duration

    During procedure

  • Iatrogenic errors

    During procedure

Study Arms (2)

Traditional group

ACTIVE COMPARATOR

In this group traditional access cavity and canal preparations is done

Procedure: Root canal treatment

Minimally invasive group

ACTIVE COMPARATOR

In this group conservative access cavity and minimally invasive root canal preparation is done

Procedure: Root canal treatment

Interventions

Root canal treatmentPROCEDURE

Root canal treatment is done

Minimally invasive groupTraditional group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry, Assiut university

Asyut, Asyut Governorate, Egypt

Location

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant lecturer in endodontics, ,faculty of dentistry, Assiut University

Study Record Dates

First Submitted

July 22, 2026

First Posted

August 13, 2026

Study Start

July 23, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

August 13, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

All collected IPD

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Beginning after publication of results and ending after 2 years

Locations

EG(1)