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
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.
- 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