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Not yet recruitingNCT07762248Updated Aug 13, 2026

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

A Phase 2/3 interventional study of Root canal treatment in Necrotic Mandibular Molars and Apical Periodontitis, sponsored by Mohamed Ashraf Abdeen. Not yet recruiting at 1 site in Egypt. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Mohamed Ashraf Abdeen · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 37 studies in Periapical Periodontitis with a site in Egypt — 11 open to participants now, 16 under way, 2 of them phase 3. Periapical Periodontitis · Egypt.

Planned enrollment
7th of 37
60 · median 45
Started
2026
with 7 others
Phase 2/3
2 of 37
2 open now
Primary completion
2027-09
later than 14 of 15 live
Registered
29th of 37
by date

Among the 37 studies in Periapical Periodontitis with a site in Egypt, this one is the 7th largest by planned enrollment, is one of 8 that started in 2026, is one of 2 in phase 2/3, reaches primary completion later than 14 of the 15 other live ones, and was the 29th registered.

Periapical Periodontitis

280 studies on the registry are indexed under Periapical Periodontitis; 79 are open to participants now.

Browse Periapical Periodontitis studies →

Open to participants now

11 of the 37 studies in Periapical Periodontitis with a site in Egypt are open now. Recruiting first, the newest first:

5 more — sign in →

All 11 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 43 Periapical Periodontitis studies recruiting now, 17 (40%) set no upper age limit and 25 (58%) stop at 75 or younger; 5 take children under 18; 21 take healthy volunteers.

This study: 20 Years to 50 Years · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Necrotic Mandibular Molars
  • Apical Periodontitis

Keywords

  • Minimally invasive endodontics
04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Traditional group

    In this group traditional access cavity and canal preparations is done

    Procedure: Root canal treatment

  • Active comparator
    Minimally invasive group

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

    Procedure: Root canal treatment

Interventions

  • ProcedureRoot canal treatment

    Root canal treatment is done

06

What researchers measure

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.

    Time frame: 1 year follow up

Secondary outcomes

  1. 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.

    Time frame: 1 year

  2. 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.

    Time frame: Within 2 days after intervention

  3. 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.

    Time frame: During procedure

  4. 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.

    Time frame: During procedure

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes — All collected IPD

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: Beginning after publication of results and ending after 2 years

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jul 2026; primary completion for Sep 2027, 14 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 22, 2026
First posted
Aug 13, 2026
StartEst.
Jul 23, 2026
Primary completionEst.
Sep 2027
CompletionEst.
Sep 2027
Last update
Aug 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07762248
Lead sponsor
Mohamed Ashraf Abdeen
Responsible party
Mohamed Ashraf Abdeen (Assistant lecturer in endodontics, ,faculty of dentistry, Assiut University, Assiut University) — Sponsor-investigator
First posted
Aug 13, 2026
Start date
Jul 23, 2026 (estimated)
Primary completion
Sep 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Aug 13, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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