Apical PeriodontitisPhase 2NACNCT07262554
N-acetylcysteine for Root Canal Treatment of Necrotic Teeth With Apical Periodontitis
A Phase 2 study testing Calcium hydroxide (Ca(OH)₂) and N-Acetylcysteine (NAC) in people with Apical Periodontitis, run by Alexandria University at 1 site in Egypt.
Trial summary
A randomized controlled trial comparing the postoperative pain intensity, periapical biomarkers level, and periapical healing in patients with necrotic mature teeth and apical periodontitis treated with N-acetylcysteine (NAC), as an intracanal and adjunctive systemic medication, versus calcium hydroxide (Ca(OH)₂)… Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Apical Periodontitis
- What is being tested?
- Calcium hydroxide (Ca(OH)₂) and N-Acetylcysteine (NAC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2025to Jun 2026
- Phase
- Phase 2
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Mature necrotic teeth.
- Radiographic evidence of periapical bone loss.
- Teeth that require primary endodontic treatment.
- Restorable teeth.
Who cannot join
- Immature teeth
- Teeth that had been previously accessed or endodontically treated.
- Teeth with periodontal pockets deeper than 4 mm.
- Patients with acute apical abscess.
- Patients with systemic diseases.
- Pregnant females.
- Patients who received antibiotic therapy within the past month.
- Patient on analgesics.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of N-acetylcysteine as an Intracanal and Adjunctive Systemic Medication in Root Canal Treatment of Necrotic Mature Teeth With Apical Periodontitis: a Randomized Controlled Clinical Trial
A randomized controlled trial comparing the postoperative pain intensity, periapical biomarkers level, and periapical healing in patients with necrotic mature teeth and apical periodontitis treated with N-acetylcysteine (NAC), as an intracanal and adjunctive systemic medication, versus calcium hydroxide (Ca(OH)₂) intracanal medication alone.
- Conditions
- Apical Periodontitis
- Being tested
- Calcium hydroxide (Ca(OH)₂), N-Acetylcysteine (NAC)
- Keywords
- N-acetylcysteine (NAC), Calcium hydroxide (Ca(OH)₂), Intracanal medication, Root canal treatment, Apical periodontitis, Postoperative pain, Periapical healing, Periapical tissue biomarkers, Cone-beam computed tomography (CBCT)
- Medical subject headings
- Periapical Periodontitis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium hydroxide (Ca(OH)₂)Drug
UltraCal XS calcium hydroxide (Ca(OH)₂) intracanal medication for 7 days
N-Acetylcysteine (NAC)Drug
Also called Acetylcysteine, N-Acetyl-L-cysteine
N-acetylcysteine (NAC) intracanal medication for 7 days and 600 mg/day oral NAC for 21 days
| Study group | Role | What they receive |
|---|---|---|
| Calcium hydroxide (Ca(OH)₂) | Active comparator | UltraCal XS calcium hydroxide (Ca(OH)₂) intracanal medication for 7 days Receives: Drug: Calcium hydroxide (Ca(OH)₂) |
| N-acetylcysteine (NAC) | Experimental | N-acetylcysteine (NAC) intracanal medication for 7 days and 600 mg/day oral NAC for 21 days Receives: Drug: N-Acetylcysteine (NAC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity
Postoperative pain will be assessed using the Numerical Rating Scale (NRS), which is a scale from 0 (no pain) to 10 (worst pain imaginable). Patients will be asked to choose the number that represents their pain intensity. Pain level will be assigned as follows: 0, "no pain"; 1-3, "mild pain"; 4-6, "moderate pain"; 7-10, "severe pain."
Measured: Pain will be recorded before the intervention, and patients will use the Numerical Rating Scale (NRS) to self-assess postoperative pain at 6 hours, 12 hours, 24 hours, 48 hours, 72 hours, and 1 week.
Assessment of periapical healing
Assessment of the percentage change in lesion volume through three-dimensional (3D) reconstruction of the lesions in Cone beam computed tomographic (CBCT) scans performed preoperatively and after a six-month follow-up.
Measured: A CBCT scan will be taken preoperatively and at six months follow-up.
Secondary outcomes (1)
Change in the level of periapical tissues biomarkers
The biomarker levels will be measured using enzyme-linked immunosorbent assay [ELISA]. Samples of periapical tissue fluid will be taken by inserting three sterile paper points into the root canal, about 2 mm beyond the working length, and holding them in place for 1 minute. The paper points will be transferred to a 1.5-mL Eppendorf and stored at -80°C until further analysis.
Measured: Samples will be collected from the periapical tissue fluid at two different points: before (S1) and after 7 days of administration of medications (S2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start15 Nov 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical PeriodontitisStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two groups. Group I (control group): UltraCal XS calcium hydroxide (Ca(OH)₂) intracanal medication for 7 days; and Group II: N-acetylcysteine (NAC) intracanal medication for 7 days and 600 mg/day oral NAC for 21 days.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Hussein, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262554
- Sponsor's protocol ID
- 9258326
- Other IDs
- PACTR202511513893768
- Acronym
- NAC
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2025
- Last updated
- 30 Dec 2025
- 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 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of N-acetylcysteine as an Intracanal and Adjunctive Systemic Medication in Root Canal Treatment of Necrotic Mature Teeth With Apical Periodontitis: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07262554
- Acronym / sponsor ID
- NAC / 9258326
- Conditions
- Apical Periodontitis
- Keywords
- N-acetylcysteine (NAC), Calcium hydroxide (Ca(OH)₂), Intracanal medication, Root canal treatment, Apical periodontitis, Postoperative pain, Periapical healing, Periapical tissue biomarkers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 3 Dec 2025 (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.
A randomized controlled trial comparing the postoperative pain intensity, periapical biomarkers level, and periapical healing in patients with necrotic mature teeth and apical periodontitis treated with N-acetylcysteine (NAC), as an intracanal and adjunctive systemic medication, versus calcium hydroxide (Ca(OH)₂) intracanal medication alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two groups. Group I (control group): UltraCal XS calcium hydroxide (Ca(OH)₂) intracanal medication for 7 days; and Group II: N-acetylcysteine (NAC) intracanal medication for 7 days and 600 mg/day oral NAC for 21 days.
| Arm | Type | Receives |
|---|---|---|
| Calcium hydroxide (Ca(OH)₂) | Active comparator | Drug: Calcium hydroxide (Ca(OH)₂)UltraCal XS calcium hydroxide (Ca(OH)₂) intracanal medication for 7 days |
| N-acetylcysteine (NAC) | Experimental | Drug: N-Acetylcysteine (NAC)N-acetylcysteine (NAC) intracanal medication for 7 days and 600 mg/day oral NAC for 21 days |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Mature necrotic teeth.
- Radiographic evidence of periapical bone loss.
- Teeth that require primary endodontic treatment.
- Restorable teeth.
Key exclusion criteria (8 listed)
- Immature teeth
- Teeth that had been previously accessed or endodontically treated.
- Teeth with periodontal pockets deeper than 4 mm.
- Patients with acute apical abscess.
- Patients with systemic diseases.
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 |
|---|---|---|
| Calcium hydroxide (Ca(OH)₂)UltraCal XS calcium hydroxide (Ca(OH)₂) intracanal medication for 7 days | Drug | Calcium hydroxide (Ca(OH)₂) |
| N-Acetylcysteine (NAC)Also: Acetylcysteine, N-Acetyl-L-cysteineN-acetylcysteine (NAC) intracanal medication for 7 days and 600 mg/day oral NAC for 21 days | Drug | N-acetylcysteine (NAC) |
Primary outcome
Postoperative pain intensity
Time frame: Pain will be recorded before the intervention, and patients will use the Numerical Rating Scale (NRS) to self-assess postoperative pain at 6 hours, 12 hours, 24 hours, 48 hours, 72 hours, and 1 week.
Postoperative pain will be assessed using the Numerical Rating Scale (NRS), which is a scale from 0 (no pain) to 10 (worst pain imaginable). Patients will be asked to choose the number that represents their pain intensity. Pain level will be assigned as follows: 0, "no pain"; 1-3, "mild pain"; 4-6, "moderate pain"; 7-10, "severe pain."
Assessment of periapical healing
Time frame: A CBCT scan will be taken preoperatively and at six months follow-up.
Assessment of the percentage change in lesion volume through three-dimensional (3D) reconstruction of the lesions in Cone beam computed tomographic (CBCT) scans performed preoperatively and after a six-month follow-up.
1 secondary outcome
Change in the level of periapical tissues biomarkers
Time frame: Samples will be collected from the periapical tissue fluid at two different points: before (S1) and after 7 days of administration of medications (S2).
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 30 Dec 2025.
- Individual participant dataSharing planned: No
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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 Phase 2 study testing Calcium hydroxide (Ca(OH)₂) and N-Acetylcysteine (NAC) in people with Apical Periodontitis, run by Alexandria University 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 4 inclusion and 8 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 30 Dec 2025. 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 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.
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?
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?
Postoperative pain intensity (time frame: Pain will be recorded before the intervention, and patients will use the Numerical Rating Scale (NRS) to self-assess postoperative pain at 6 hours, 12 hours, 24 hours, 48 hours, 72 hours, and 1 week.). The study lists 2 primary outcomes in all. 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 30 Dec 2025.