Necrotic Mandibular MolarsPhase 2/3NCT07762248
Impact of Minimally Invasive Endodontic Treatment on the Prognosis of Mandibular Permanent Molars With Necrotic Pulp and Apical Periodontitis
A Phase 2/3 study testing Root canal treatment in people with Necrotic Mandibular Molars and Apical Periodontitis, run by Mohamed Ashraf Abdeen at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Necrotic Mandibular Molars, Apical Periodontitis
- What is being tested?
- Root canal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Jul 2026to Sep 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of dentistry, Assiut university
Asyut, Asyut Governorate
Mohamed Ashraf Abdeen, Msc, 00201006518663, M.abdeen@dent.aun.edu.eg
About this study
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.
- Conditions
- Necrotic Mandibular Molars, Apical Periodontitis
- Being tested
- Root canal treatment
- Keywords
- Minimally invasive endodontics
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root canal treatmentProcedure or surgery
Root canal treatment is done
| Study group | Role | What they receive |
|---|---|---|
| Traditional group | Active comparator | In this group traditional access cavity and canal preparations is done Receives: Procedure: Root canal treatment |
| Minimally invasive group | Active comparator | In this group conservative access cavity and minimally invasive root canal preparation is done Receives: Procedure: Root canal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year follow up
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start23 Jul 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotic Mandibular MolarsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed Ashraf Abdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Ashraf Abdeen, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762248
- Sponsor's protocol ID
- Minimally invasive endo
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Minimally Invasive Endodontic Treatment on the Prognosis of Mandibular Permanent Molars With Necrotic Pulp and Apical Periodontitis
- ClinicalTrials.gov ID
- NCT07762248
- Acronym / sponsor ID
- Minimally invasive endo
- Conditions
- Necrotic Mandibular Molars, Apical Periodontitis
- Keywords
- Minimally invasive endodontics
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mohamed Ashraf AbdeenUniversity, hospital or other
- Study start
- 23 Jul 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional group | Active comparator | Procedure: Root canal treatmentIn this group traditional access cavity and canal preparations is done |
| Minimally invasive group | Active comparator | Procedure: Root canal treatmentIn this group conservative access cavity and minimally invasive root canal preparation is done |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Root canal treatmentRoot canal treatment is done | Procedure or surgery | Minimally invasive group, Traditional group |
Primary outcome
Success rate
Time frame: 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.
4 secondary outcomes
Healing of periapical lesion
Time frame: 1 year
Bacterial load
Time frame: Within 2 days after intervention
Treatment duration
Time frame: During procedure
Iatrogenic errors
Time frame: During procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: Yes. All collected IPD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Root canal treatment in people with Necrotic Mandibular Molars and Apical Periodontitis, run by Mohamed Ashraf Abdeen at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate (time frame: 1 year follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.