Necrotic Pulp With Symptomatic Apical PeriodontitisNCT07589556
Evaluation of the Impact of Different Final Irrigation Activation Modes on Healing of Periapical Lesions Related to Permanent Mandibular First Molars Using CBCT.
A study testing root canal treatment in people with Necrotic Pulp With Symptomatic Apical Periodontitis, run by Future University in Egypt at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn how different ways of activating the cleaning liquid (irrigation) during endodontic treatment affect healing of infections at the root tip (periapical lesions) in adults aged 20 to 40 with a lower first molar tooth. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Necrotic Pulp With Symptomatic Apical Periodontitis
- What is being tested?
- root canal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2025to 1 Oct 2026
- Phase
- Interventional
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- - Medically free patients with no systemic disease: (American Society of Anesthesiologists / (ASA Class I or II).
- The age range is between 20 to 40 years.
- Patients have restorable Mandibular permanent molars that were diagnosed with necrotic pulp with symptomatic apical periodontitis (with small to moderate periapical lesion/≤ 5mm) .
- Positive patient's acceptance for participating in the study.
- Patients able to sign informed consent.
- Both male and female patients are eligible.
- Good oral hygiene.
- Mandibular first molars with two roots (mesial and distal), each presenting a Weine Type III canal configuration.
Who cannot join
- - Medically compromised patients.
- Pregnant or lactating females.
- Psychologically disturbed patients.
- Patients with a history of allergy to any medication used in the study were excluded.
- Mandibular first molar with:
- Wide or open apex.
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- Vital pulp tissues.
- Periodontally affected with grade 2 or 3 mobility.
- Not restorable teeth.
- Abnormal anatomy and calcified canals.
- Previous root canal treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Impact of Different Final Irrigation Activation Modes on Healing of Periapical Lesions Related to Permanent Mandibular First Molars Using CBCT. A Randomized Controlled Trial.
The goal of this clinical trial is to learn how different ways of activating the cleaning liquid (irrigation) during endodontic treatment affect healing of infections at the root tip (periapical lesions) in adults aged 20 to 40 with a lower first molar tooth.
The main question it aims to answer is:
Read more
Does the way the cleaning liquid is moved inside the tooth during endodontic treatment change how well the infection at the root tip heals after 12 months?
Researchers will compare four irrigation methods to see which one helps the infection heal best:
A regular needle and syringe (the standard endodontic method) Ultra X, which uses sound waves to push the liquid through the tooth Endo Vac, which uses gentle suction to pull the liquid through the tooth I Vac, which combines suction and sound waves
Participants will:
Have their endodontic treatment done in one visit by the same dentist Be randomly placed into one of the four groups Return for check-ups at 3, 6, and 9 months after endodontic treatment Come back at 12 months for a final check-up and a 3D dental scan (CBCT) to measure how much the infection has healed
Read the detailed description
Periapical lesions are areas of infection and inflammation at the tip of a tooth's root. They develop when bacteria from inside the tooth's root canal system spread to the surrounding bone. Endodontic treatment (root canal treatment) aims to remove these bacteria so the infection can heal.
A key part of endodontic treatment is irrigation, which means rinsing the inside of the tooth with cleaning liquids to wash out bacteria, infected tissue, and debris. The two main cleaning liquids used in this study are sodium hypochlorite (NaOCl), which dissolves infected tissue and kills bacteria, and EDTA, which removes the smear layer (a thin film of debris left on the canal walls after cleaning).
The standard way to deliver these liquids is with a needle and syringe. However, the inside of a tooth has complex shapes, narrow areas, and side branches that a needle may not reach. To improve cleaning, dentists can use special devices that activate the liquid, helping it flow into these hard-to-reach areas. Different activation methods work in different ways:
Positive pressure activation uses sound waves to push the liquid deeper into the canals Negative pressure activation uses gentle suction to pull the liquid through the canals toward the root tip, which also helps stop the liquid from being pushed out beyond the root Combined activation uses both suction and sound waves at the same time
It is not yet clear which activation method leads to the best healing of periapical lesions over time. This study will compare four irrigation methods in adults to find out.
Study Design
This is a randomized controlled clinical trial. A total of 52 adults aged 20 to 40 years will take part. Participants will be randomly placed into one of four equal groups (13 people per group):
Group A (control group): Conventional needle irrigation. The cleaning liquid is delivered with a regular side-vented needle placed 2 mm short of the root tip.
Group B: Ultra X activation. A device that uses sound waves to activate the liquid.
Group C: Endo Vac activation. A device that uses suction to pull the liquid through the canals.
Group D: I Vac activation. A device that combines suction and sound waves.
Who Can Take Part
People may join the study if they:
Are between 20 and 40 years old Are in good general health Have a lower first molar that can be restored, with signs of symptomatic apical periodontitis and a small to moderate periapical lesion seen on a CBCT scan Agree to take part and sign a consent form
People cannot join the study if they:
Have a serious medical condition Are pregnant or breastfeeding Have an allergy to any medication used in the study Have a tooth that is loose, cannot be restored, has unusual anatomy, or has already had a root canal
What Participants Will Do
All endodontic treatment will be done in one visit by the same dentist. The steps are:
A full medical and dental history will be taken Before treatment, X-rays and a 3D dental scan (CBCT) will be taken to measure the size of the infection. This scan is the baseline for comparing how much healing happens later The tooth area will be numbed with local anesthesia Any decay will be removed and the tooth will be opened to reach the canals A rubber dam will be placed around the tooth to keep it clean and dry The length of each canal will be measured using an electronic device and confirmed with an X-ray The canals will be shaped and cleaned using rotary files, with 2.5% sodium hypochlorite used between each file The final rinse will be done using the method assigned to the participant's group, with 17% EDTA followed by 2.5% sodium hypochlorite. Saline will be used between liquids to prevent them from mixing The canals will be dried and filled using gutta-percha and a resin-based sealer The tooth will be restored with a resin composite filling
Follow-Up Participants will return for follow-up visits at 3, 6, 9, and 12 months. At each visit, the dentist will check the tooth and take a regular X-ray. At the 12-month visit, a new CBCT scan will be taken to measure how much the infection has healed.
How Healing Is Measured
The main outcome is healing of the periapical lesion at 12 months, measured using the Cone Beam Computed Tomography Periapical Index (CBCT-PAI). At 12 months, each tooth will be placed into one of three groups:
Healed: No symptoms and a CBCT-PAI score of 1 or 2, or no sign of infection on the scan Healing: No symptoms and a smaller lesion on the scan Diseased: Symptoms are present, or the lesion is the same size or larger
Teeth that are healed or healing will be counted as successful treatment. Teeth that are diseased will be counted as unsuccessful.
Risks and Confidentiality Any side effects will be recorded. All participant information will be kept private and stored securely. Data will be password-protected and kept for one year after the study ends.
- Being tested
- root canal treatment
- Keywords
- apical periodontitis, iVac, healing, CBCT, Final Irrigation protocol, EndoVac, ultrasonic, Root canal treatment
- 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
single visit root canal treatment with final irrigation protocol according to arm
| Study group | Role | What they receive |
|---|---|---|
| side vented needle | Placebo comparator | single visit root canal treatment with final irrigation protocol using side vented needle Receives: Procedure: root canal treatment |
| passive ultrasonic irrigation activation (Ultra X ) | Active comparator | single visit root canal treatment with final irrigation protocol using ultrasonic ( Ultra X ) Receives: Procedure: root canal treatment |
| apical negative pressure irrigation activation ( Endo Vac) | Active comparator | single visit root canal treatment with final irrigation protocol using apical negative pressure irrigation activation( Endo Vac ) Receives: Procedure: root canal treatment |
| Apical Negative Pressure Irrigation and Activation System (iVac) | Active comparator | single visit root canal treatment with final irrigation protocol using Apical Negative Pressure Irrigation and Activation System (iVac) Receives: Procedure: root canal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
healing of periapical lesion
percent reduction lesion size after root canal treatment using CBCT-PAI scores
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start15 Jan 2025
- Primary completion3 May 2026
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotic Pulp With Symptomatic Apical PeriodontitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Fawzy Mohamed Sayed Ahmed Omara, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589556
- Sponsor's protocol ID
- FUE.REC (45)/11-2024
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Different Final Irrigation Activation Modes on Healing of Periapical Lesions Related to Permanent Mandibular First Molars Using CBCT. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07589556
- Acronym / sponsor ID
- FUE.REC (45)/11-2024
- Keywords
- apical periodontitis, iVac, healing, CBCT, Final Irrigation protocol, EndoVac, ultrasonic, Root canal treatment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 3 May 2026 (actual)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 15 May 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.
The goal of this clinical trial is to learn how different ways of activating the cleaning liquid (irrigation) during endodontic treatment affect healing of infections at the root tip (periapical lesions) in adults aged 20 to 40 with a lower first molar tooth.
The main question it aims to answer is:
Does the way the cleaning liquid is moved inside the tooth during endodontic treatment change how well the infection at the root tip heals after 12 months?
Researchers will compare four irrigation methods to see which one helps the infection heal best:
A regular needle and syringe (the standard endodontic method) Ultra X, which uses sound waves to push the liquid through the tooth Endo Vac, which uses gentle suction to pull the liquid through the tooth I Vac, which combines suction and sound waves
Participants will:
Have their endodontic treatment done in one visit by the same dentist Be randomly placed into one of the four groups Return for check-ups at 3, 6, and 9 months after endodontic treatment Come back at 12 months for a final check-up and a 3D dental scan (CBCT) to measure how much the infection has healed
Detailed description
Periapical lesions are areas of infection and inflammation at the tip of a tooth's root. They develop when bacteria from inside the tooth's root canal system spread to the surrounding bone. Endodontic treatment (root canal treatment) aims to remove these bacteria so the infection can heal.
A key part of endodontic treatment is irrigation, which means rinsing the inside of the tooth with cleaning liquids to wash out bacteria, infected tissue, and debris. The two main cleaning liquids used in this study are sodium hypochlorite (NaOCl), which dissolves infected tissue and kills bacteria, and EDTA, which removes the smear layer (a thin film of debris left on the canal walls after cleaning).
The standard way to deliver these liquids is with a needle and syringe. However, the inside of a tooth has complex shapes, narrow areas, and side branches that a needle may not reach. To improve cleaning, dentists can use special devices that activate the liquid, helping it flow into these hard-to-reach areas. Different activation methods work in different ways:
Positive pressure activation uses sound waves to push the liquid deeper into the canals Negative pressure activation uses gentle suction to pull the liquid through the canals toward the root tip, which also helps stop the liquid from being pushed out beyond the root Combined activation uses both suction and sound waves at the same time
It is not yet clear which activation method leads to the best healing of periapical lesions over time. This study will compare four irrigation methods in adults to find out.
Study Design
This is a randomized controlled clinical trial. A total of 52 adults aged 20 to 40 years will take part. Participants will be randomly placed into one of four equal groups (13 people per group):
Group A (control group): Conventional needle irrigation. The cleaning liquid is delivered with a regular side-vented needle placed 2 mm short of the root tip.
Group B: Ultra X activation. A device that uses sound waves to activate the liquid.
Group C: Endo Vac activation. A device that uses suction to pull the liquid through the canals.
Group D: I Vac activation. A device that combines suction and sound waves.
Who Can Take Part
People may join the study if they:
Are between 20 and 40 years old Are in good general health Have a lower first molar that can be restored, with signs of symptomatic apical periodontitis and a small to moderate periapical lesion seen on a CBCT scan Agree to take part and sign a consent form
People cannot join the study if they:
Have a serious medical condition Are pregnant or breastfeeding Have an allergy to any medication used in the study Have a tooth that is loose, cannot be restored, has unusual anatomy, or has already had a root canal
What Participants Will Do
All endodontic treatment will be done in one visit by the same dentist. The steps are:
A full medical and dental history will be taken Before treatment, X-rays and a 3D dental scan (CBCT) will be taken to measure the size of the infection. This scan is the baseline for comparing how much healing happens later The tooth area will be numbed with local anesthesia Any decay will be removed and the tooth will be opened to reach the canals A rubber dam will be placed around the tooth to keep it clean and dry The length of each canal will be measured using an electronic device and confirmed with an X-ray The canals will be shaped and cleaned using rotary files, with 2.5% sodium hypochlorite used between each file The final rinse will be done using the method assigned to the participant's group, with 17% EDTA followed by 2.5% sodium hypochlorite. Saline will be used between liquids to prevent them from mixing The canals will be dried and filled using gutta-percha and a resin-based sealer The tooth will be restored with a resin composite filling
Follow-Up Participants will return for follow-up visits at 3, 6, 9, and 12 months. At each visit, the dentist will check the tooth and take a regular X-ray. At the 12-month visit, a new CBCT scan will be taken to measure how much the infection has healed.
How Healing Is Measured
The main outcome is healing of the periapical lesion at 12 months, measured using the Cone Beam Computed Tomography Periapical Index (CBCT-PAI). At 12 months, each tooth will be placed into one of three groups:
Healed: No symptoms and a CBCT-PAI score of 1 or 2, or no sign of infection on the scan Healing: No symptoms and a smaller lesion on the scan Diseased: Symptoms are present, or the lesion is the same size or larger
Teeth that are healed or healing will be counted as successful treatment. Teeth that are diseased will be counted as unsuccessful.
Risks and Confidentiality Any side effects will be recorded. All participant information will be kept private and stored securely. Data will be password-protected and kept for one year after the study ends.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| side vented needle | Placebo comparator | Procedure: root canal treatmentsingle visit root canal treatment with final irrigation protocol using side vented needle |
| passive ultrasonic irrigation activation (Ultra X ) | Active comparator | Procedure: root canal treatmentsingle visit root canal treatment with final irrigation protocol using ultrasonic ( Ultra X ) |
| apical negative pressure irrigation activation ( Endo Vac) | Active comparator | Procedure: root canal treatmentsingle visit root canal treatment with final irrigation protocol using apical negative pressure irrigation activation( Endo Vac ) |
| Apical Negative Pressure Irrigation and Activation System (iVac) | Active comparator | Procedure: root canal treatmentsingle visit root canal treatment with final irrigation protocol using Apical Negative Pressure Irrigation and Activation System (iVac) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- - Medically free patients with no systemic disease: (American Society of Anesthesiologists / (ASA Class I or II).
- The age range is between 20 to 40 years.
- Patients have restorable Mandibular permanent molars that were diagnosed with necrotic pulp with symptomatic apical periodontitis (with small to moderate periapical lesion/≤ 5mm) .
- Positive patient's acceptance for participating in the study.
- Patients able to sign informed consent.
Key exclusion criteria (11 listed)
- - Medically compromised patients.
- Pregnant or lactating females.
- Psychologically disturbed patients.
- Patients with a history of allergy to any medication used in the study were excluded.
- Mandibular first molar with:
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 treatmentsingle visit root canal treatment with final irrigation protocol according to arm | Procedure or surgery | Apical Negative Pressure Irrigation and Activation System (iVac), apical negative pressure irrigation activation ( Endo Vac), passive ultrasonic irrigation activation (Ultra X ), side vented needle |
Primary outcome
healing of periapical lesion
Time frame: 12 month
percent reduction lesion size after root canal treatment using CBCT-PAI scores
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 15 May 2026.
- Individual participant dataSharing planned: No
Related trials for Necrotic Pulp With Symptomatic Apical Periodontitis
Active, not recruitingEarly Phase 1
Comparing the Effectiveness of Hyalone and Calcium Hydroxide in Reducing Post-operative Pain and Promoting Periapical Healing.
Pain Management
Active, not recruitingPhase 2
Evaluation of Postoperative Pain and Bacterial Load After Hyalone or Calcium Hydroxide Medication in Mandibular First Molars
Bacterial Load Reduction, Postoperative Pain
Active, not recruiting
The Impact of Using Different Final Irrigation Modes on Postoperative Pain Following Root Canal Treatment of Non-vital Mandibular First Molar With Periapical Lesion.
Necrotic Pulp With Symptomatic Apical Periodontitis
Not yet recruiting
Evaluation of Postoperative Pain and Antimicrobial Efficacy of Selenium Versus Calcium Hydroxide As Intracanal Medication in Mandibular First Molars with Necrotic Pulp and Symptomatic Apical Periodontitis
Necrotic Pulp with Symptomatic Apical Periodontitis, Postoperative Dental Pain
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing root canal treatment in people with Necrotic Pulp With Symptomatic Apical Periodontitis, run by Future University in Egypt 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 8 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 15 May 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
healing of periapical lesion (time frame: 12 month). 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 15 May 2026.