Chronic Apical PeriodontitisNCT06834711
Chlorhexidine Versus N-Asetil Sistein Irrigation in Mandibular Molar Teeth with Chronic Apical Periodontitis
A study testing N-Acetyl Cysteine and Chlorhexidine in people with Chronic Apical Periodontitis, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical study was to evaluate the effect of using different irrigation solutions in the final irrigation of root canal treatment procedures on the intensity of postoperative pain and periapical tissue healing in patients presenting with mandibular molars with chronic apical periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Chronic Apical Periodontitis
- What is being tested?
- N-Acetyl Cysteine and Chlorhexidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2024to 5 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Mandibular permanent molars with chronic apical periodontitis
- Teeth with periapical index (PAI) score greater than 2
- Teeth with periodontal pocket depth less than 3 mm
- Patients without systemic disease (ASA 1-2)
Who cannot join
- Patients who have used analgesic, anti-inflammatory or opioid drugs in the last 7 days or antibiotics in the last 3 months
- Patients who report pregnancy, lactation or psychiatric disorders
- Teeth with a history of root canal treatment, sinus tract or abscess, and teeth planned for prosthetic restoration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chlorhexidin Versus N-Asetil Sistein Irrigation in Mandibular Molar Teeth with Chronic Apical Periodontitis on Postoperative Pain and Periapical Tissue Healing: a Randomized Controlled Trial
The goal of this clinical study was to evaluate the effect of using different irrigation solutions in the final irrigation of root canal treatment procedures on the intensity of postoperative pain and periapical tissue healing in patients presenting with mandibular molars with chronic apical periodontitis. The main question it aims to answer is:
- Does controlled irrigation with chlorhexidin and N-asetil sistein in root canal treatment reduce the severity of postoperative pain? In the chlorhexidin group, unlike the control group, each root canal was irrigated with 3 mL %2 chlorhexidin solution in the final irrigation.
In the N-asetil sistein group, unlike the control group, each root canal was irrigated with 3 mL 200 mg/ml N-asetil sistein solution in the final irrigation.
- Conditions
- Chronic Apical Periodontitis
- Being tested
- N-Acetyl Cysteine, Chlorhexidine
- Keywords
- chronic apical periodontitis, postoperative pain, N-asetil sistemin, chlorhexidin
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-Acetyl CysteineDrug
The root canals were irrigated with 3 mL N-acetyl Cysteine (NAC)(200 mg/ml) in N-acetyl Cysteine group in the final irrigation.
ChlorhexidineDrug
The root canals were irrigated with 3 ml %2 chlorhexidine in chlorhexidin group in the final irrigation.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | During root canal preparation, each canal was irrigated with a total of 18 ml of 2.5% sodium hypochlorite (NaOCl). In the final irrigation, each root canal was irrigated with 3 ml of 17% ethylene diamine tetra-acetic acid (EDTA) for 1 minute, followed by 5 ml of distilled water. Then, 5 ml of 2.5% NaOCl was irrigated, and finally 5 ml of distilled water was used. |
| Chlorhexidine Group | Experimental | During root canal preparation, each canal was irrigated with a total of 18 ml of 2.5% NaOCl. In the final irrigation, each root canal was irrigated with 3 ml of 17% ethylene diamine tetra-acetic acid (EDTA) for 1 minute, followed by 5 ml of distilled water. Then, each canal was irrigated with 3 ml of 2% chlorhexidine (CHX) and finally 5 ml of distilled water was used. Receives: Drug: Chlorhexidine |
| N-asetil Sistein Group | Experimental | During root canal preparation, each canal was irrigated with a total of 18 ml of 2.5% NaOCl. In the final irrigation, each root canal was irrigated with 3 ml of 17% ethylene diamine tetra-acetic acid (EDTA) for 1 minute, followed by 5 ml of distilled water. Then, each canal was irrigated with 3 ml of N-acetyl Cysteine (NAC) (200 mg/ml) and finally 5 ml of distilled water was used. Receives: Drug: N-Acetyl Cysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
The visual analog scale for pain is a straight line with one end meaning no pain (0) and the other end meaning the worst pain (10) imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. It may be used to help choose the right dose of pain medicine. Also called VAS.
Measured: up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start15 Feb 2024
- Primary completion12 Dec 2024
- Study completion5 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Apical PeriodontitisStudies of the same condition, open and under way.
- More trials run by Cukurova 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Gürler, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834711
- Sponsor's protocol ID
- 13.02.2025/152
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Corazza BJM, Martinho FC, Khoury RD, Toia CC, Orozco EIF, Prado RF, Machado FP, Valera MC. Clinical influence of calcium hydroxide and N-acetylcysteine on the levels of resolvins E1 and D2 in apical periodontitis. Int Endod J. 2021 Jan;54(1):61-73. doi: 10.1111/iej.13403. Epub 2020 Oct 3.
PubMed 32896000Comparative evaluation of N-acetylcysteine and chlorhexidine as final irrigation on the push-out bond strength of different sealers: An in vitro study
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chlorhexidin Versus N-Asetil Sistein Irrigation in Mandibular Molar Teeth with Chronic Apical Periodontitis on Postoperative Pain and Periapical Tissue Healing: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06834711
- Acronym / sponsor ID
- 13.02.2025/152
- Conditions
- Chronic Apical Periodontitis
- Keywords
- chronic apical periodontitis, postoperative pain, N-asetil sistemin, chlorhexidin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 5 Jan 2025 (actual)
- First posted
- 19 Feb 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.
The goal of this clinical study was to evaluate the effect of using different irrigation solutions in the final irrigation of root canal treatment procedures on the intensity of postoperative pain and periapical tissue healing in patients presenting with mandibular molars with chronic apical periodontitis. The main question it aims to answer is:
- Does controlled irrigation with chlorhexidin and N-asetil sistein in root canal treatment reduce the severity of postoperative pain? In the chlorhexidin group, unlike the control group, each root canal was irrigated with 3 mL %2 chlorhexidin solution in the final irrigation.
In the N-asetil sistein group, unlike the control group, each root canal was irrigated with 3 mL 200 mg/ml N-asetil sistein solution in the final irrigation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –During root canal preparation, each canal was irrigated with a total of 18 ml of 2.5% sodium hypochlorite (NaOCl). In the final irrigation, each root canal was irrigated with 3 ml of 17% ethylene diamine tetra-acetic acid (EDTA) for 1 minute, followed by 5 ml of distilled water. Then, 5 ml of 2.5% NaOCl was irrigated, and finally 5 ml of distilled water was used. |
| Chlorhexidine Group | Experimental | Drug: ChlorhexidineDuring root canal preparation, each canal was irrigated with a total of 18 ml of 2.5% NaOCl. In the final irrigation, each root canal was irrigated with 3 ml of 17% ethylene diamine tetra-acetic acid (EDTA) for 1 minute, followed by 5 ml of distilled water. Then, each canal was irrigated with 3 ml of 2% chlorhexidine (CHX) and finally 5 ml of distilled water was used. |
| N-asetil Sistein Group | Experimental | Drug: N-Acetyl CysteineDuring root canal preparation, each canal was irrigated with a total of 18 ml of 2.5% NaOCl. In the final irrigation, each root canal was irrigated with 3 ml of 17% ethylene diamine tetra-acetic acid (EDTA) for 1 minute, followed by 5 ml of distilled water. Then, each canal was irrigated with 3 ml of N-acetyl Cysteine (NAC) (200 mg/ml) and finally 5 ml of distilled water was used. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Mandibular permanent molars with chronic apical periodontitis
- Teeth with periapical index (PAI) score greater than 2
- Teeth with periodontal pocket depth less than 3 mm
- Patients without systemic disease (ASA 1-2)
Key exclusion criteria (3 listed)
- Patients who have used analgesic, anti-inflammatory or opioid drugs in the last 7 days or antibiotics in the last 3 months
- Patients who report pregnancy, lactation or psychiatric disorders
- Teeth with a history of root canal treatment, sinus tract or abscess, and teeth planned for prosthetic restoration
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 |
|---|---|---|
| N-Acetyl CysteineThe root canals were irrigated with 3 mL N-acetyl Cysteine (NAC)(200 mg/ml) in N-acetyl Cysteine group in the final irrigation. | Drug | N-asetil Sistein Group |
| ChlorhexidineThe root canals were irrigated with 3 ml %2 chlorhexidine in chlorhexidin group in the final irrigation. | Drug | Chlorhexidine Group |
Primary outcome
Visual Analogue Scale
Time frame: up to 72 hours
The visual analog scale for pain is a straight line with one end meaning no pain (0) and the other end meaning the worst pain (10) imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. It may be used to help choose the right dose of pain medicine. Also called VAS.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Background: PubMed 32896000Corazza BJM, Martinho FC, Khoury RD, Toia CC, Orozco EIF, Prado RF, Machado FP, Valera MC. Clinical influence of calcium hydroxide and N-acetylcysteine on the levels of resolvins E1 and D2 in apical periodontitis. Int Endod J. 2021 Jan;54(1):61-73. doi: 10.1111/iej.13403. Epub 2020 Oct 3.
- BackgroundComparative evaluation of N-acetylcysteine and chlorhexidine as final irrigation on the push-out bond strength of different sealers: An in vitro study
- 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 study testing N-Acetyl Cysteine and Chlorhexidine in people with Chronic Apical Periodontitis, run by Cukurova University at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 20 Feb 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 Turkey (Türkiye). 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual Analogue Scale (time frame: up to 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06834711, which also lists 2 linked publications.
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 20 Feb 2025.