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Chronic Apical PeriodontitisNCT07340944

Comparison of the Effects of N-acetylcysteine, Calcium Hydroxide, and Double Antibiotic Paste

A study testing N Acetyl Cysteine, Calcium Hydroxide (Ca(OH)2) and Double Antibiotic Paste in people with Chronic Apical Periodontitis, run by Ataturk University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study aimed to evaluate the efficacy of N-acetylcysteine (NAC) used as an intracanal medicament on antibacterial activity, periapical RANKL/OPG ratio, and postoperative pain levels. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Apical Periodontitis
What is being tested?
N Acetyl Cysteine, Calcium Hydroxide (Ca(OH)2) and Double Antibiotic Paste
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Sep 2022to 15 May 2024
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Non-vital teeth confirmed by clinical and pulp sensitivity tests
  • Teeth with a single canal and diagnosed with asymptomatic apical periodontitis
  • Periapical assessment (PAI) of 2 or greater
  • Teeth with a pocket depth not exceeding 3 mm
  • Teeth without excessive root curvature (Schneider class 1) and with visible root canals on radiographs
  • Permanent teeth with complete root development
  • Patients between the ages of 18 and 65
  • Teeth without previous endodontic treatment

Who cannot join

  • Patients who refused to participate in the study
  • Patients with any systemic disease
  • Patients who received antibiotic treatment within the last 3 months
  • Patients who were pregnant or suspected of being pregnant
  • Teeth with excessive crown damage that would not allow for the placement of a rubber dam
  • Teeth with root fractures, pathological findings or mobility,
  • Presence of any resorption in the involved tooth,
  • Patients with active swelling and tenderness to palpation.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ataturk University

    Erzurum

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of the Effects of N-acetylcysteine, Calcium Hydroxide, and Double Antibiotic Paste on Postoperative Pain Level, Periapical RANKL/OPG Ratio, and Antibacterial Activity

This study aimed to evaluate the efficacy of N-acetylcysteine (NAC) used as an intracanal medicament on antibacterial activity, periapical RANKL/OPG ratio, and postoperative pain levels.

Read the detailed description

Apical periodontitis (AP) is a condition characterized by a dominant inflammatory response in the root canal system of the affected tooth and irreversible inflammation of the periradicular tissues caused by a microbial infection . Endodontic treatment is considered the gold standard treatment for apical periodontitis because it completely removes the pulp tissue and biofilm. During this process, lesions that may occur in the periradicular tissues due to endodontic origin can be minimized, reduced, or completely eliminated .

Numerous irrigation protocols and intracanal medications, including various mechanical instrumentation techniques, have been developed to reduce microorganisms and inflammation in the root canal system and to control pain . Intracanal medications are antibacterial agents placed within the root canal between sessions to eliminate residual microorganisms . These medications exhibit anti-inflammatory effects, thereby reducing pain, eliminating apical exudate, controlling inflammatory root resorption, and preventing contamination between sessions . However, numerous published articles on endodontic infection control debate the effectiveness of existing intracanal drugs These conflicting findings complicate the determination of an ideal intracanal drug for endodontic treatments and have led researchers to search for more effective and reliable alternatives.

N-acetylcysteine (NAC), a sulfhydryl group-containing compound with mucolytic properties, was first patented in 1960 and began to be used in medicine in 1967 . In recent years, it has been evaluated as a potential agent as an irrigating solution and intracanal medicament in endodontics. Numerous in vitro studies on the antimicrobial activity of NAC have demonstrated its high antimicrobial activity against planktonic microorganisms and multispecies biofilms responsible for endodontic infections, including Enterococcus faecalis . In addition to inhibiting the production and release of proinflammatory cytokines , it is a potent thiol-containing antioxidant with high antimicrobial activity. Furthermore, one of the limited clinical studies on the use of NAC as an intracanal medication reported significantly increased levels of the pro-resolving lipid mediators RvE1 and RvD2 in the periapical tissues of teeth treated with NAC as an intracanal medication, whereas a similar increase was not observed in the calcium hydroxide (Ca(OH)₂)-treated group . These findings demonstrate that NAC is not only noteworthy for its antimicrobial activity but also for its biological properties that may contribute to the resolution of the inflammatory response.Antimicrobial activity alone is not sufficient to assess the clinical efficacy of intracanal medicaments; the biological effects of these agents on periapical tissues should also be considered. In this context, the Nuclear factor kappa-B receptor activator ligand (RANKL)/Osteoprotegerin (OPG) ratio, a key indicator of osteoclastic activity, is a valuable biomarker for biochemically assessing treatment response in endodontic treatments because it reflects the effect of inflammation on bone destruction. Increasing RANKL levels and decreasing OPG levels have been associated with root-end resorption and periapical lesion progression. Furthermore, postoperative pain, which directly impacts patients' quality of life, is one of the key criteria for evaluating the clinical success of intracanal medications. Therefore, this study aimed to conduct a holistic analysis of intracanal medicaments from both biological and clinical perspectives by evaluating not only antimicrobial activity but also the RANKL/OPG ratio and postoperative pain levels.

To date, there are no randomized controlled trials using NAC as an intracanal medication, where each of its antibacterial activity, RANKL/OPG ratio, and effect on postoperative pain levels has been clinically evaluated. This study, which is the first to examine these three parameters separately at the clinical level, aims to evaluate the effects of NAC on postoperative pain, antibacterial activity, and the RANKL/OPG ratio by comparing it with Ca(OH)₂ and double antibiotic paste (DAP). For this purpose, our study aims to test the null hypothesis that NAC, Ca(OH)₂, and DAP used as intracanal medications have no effect on antibacterial activity, RANKL/OPG ratio, or postoperative pain levels.

Being tested
N Acetyl Cysteine, Calcium Hydroxide (Ca(OH)2), Double Antibiotic Paste
Keywords
N-acetylcysteine, calcium hydroxide, double antibiotic paste, intracanal medicament, RANKL, osteoprotegerin, postoperative pain
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

    NAC was placed into the root canal as an intracanal medication. The medication was removed after one week. Root canal treatment was completed. Treatment was completed for 15 patients in the group within one month.

  • Calcium Hydroxide (Ca(OH)2)Drug

    Ca(OH)2 was placed into the root canal as an intracanal medication. The medication was removed after one week. Root canal treatment was completed. Treatment was completed for 15 patients in the group within one month.

  • Double Antibiotic PasteDrug

    DAP was placed into the root canal as an intracanal medication. The medication was removed after one week. Root canal treatment was completed. Treatment was completed for 15 patients in the group within one month.

Study groups in NCT07340944
Study groupRoleWhat they receive
N-acetylcysteine groupExperimentalNAC was placed into the root canal as an intracanal medication.
Receives: Drug: N Acetyl Cysteine
Calcium Hydroxide GroupActive comparatorCa(OH)2 was placed into the root canal as an intracanal medication.
Receives: Drug: Calcium Hydroxide (Ca(OH)2)
Double Antibiotic Paste GroupActive comparatorDAP was placed into the root canal as an intracanal medication.
Receives: Drug: Double Antibiotic Paste

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Antibacterial efficacy of intracanal medicaments, RANKL/OPG ratio and effect on postoperative pain

    The antibacterial activity of intracanal medicaments will be measured by PCR analysis, Rankl/opg ratio will be measured by ELISA analysis and postoperative level will be measured by VAS.

    Measured: The medication will remain in the canal for one week. Patients will receive treatment within one month.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2026
  2. Study start10 Sep 2022
  3. Primary completion9 Jan 2023
  4. Study completion15 May 2024

Resources

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
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07340944
Sponsor's protocol ID
AU-DF-CY-01
Status last verified
Jan 2026
First submitted
6 Jan 2026
Last updated
15 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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