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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Apical Periodontitis; Necrotic Mandibular Molars
• Intervention / Treatment: Procedure: Root canal treatment

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Asyut Governorate
    • Asyut, Asyut Governorate, Egypt
      • Faculty of dentistry, Assiut university
      • Contact: Mohamed Ashraf Abdeen, Msc; Phone Number: 00201006518663; Email: M.abdeen@dent.aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Traditional group; In this group traditional access cavity and canal preparations is done	Procedure: Root canal treatment; Root canal treatment is done
Active Comparator: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing of periapical lesion	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	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	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	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

Collaborators and Investigators

• Sponsor: Mohamed Ashraf Abdeen

Study record dates

Study Major Dates

• Study Start (Estimated): July 23, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: July 22, 2026
• First Submitted That Met QC Criteria: August 8, 2026
• First Posted (Actual): August 13, 2026

Study Record Updates

• Last Update Posted (Actual): August 13, 2026
• Last Update Submitted That Met QC Criteria: August 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Minimally invasive endodontics
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periapical Diseases; Jaw Diseases; Periodontitis; Periapical Periodontitis
• Other Study ID Numbers: Minimally invasive endo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected IPD
• IPD Sharing Time Frame: Beginning after publication of results and ending after 2 years
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No