Modulation of Periapical Inflammation Following Nano-sized Intracanal Medication. A Randomized Controlled Clinical Trial

NCT07571837 | Recruiting DMC

• 1 other identifier: RECO6U/10-2026
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The main cause of endodontic disorders is microbial infection. From the infected pulp tissue, microorganisms can penetrate into the deeper layers of root dentine and propagate a periapical tissue through the apical foramen and lateral canals causing apical periodontitis. Apical periodontitis is an inflammatory condition affecting the periapical area of teeth with a global prevalence of 52% among individuals and 5% at tooth level. At the periapical region, microbes and their products encounter the host immune defense. Innate immune cells combat bacteria through phagocytosis and release anti-microbial substances, while adaptive immune cells initiate both cell-mediated and humoral immune responses. This immune activation also stimulates osteoclasts, leading to bone resorption and creating space for the inflammatory cells' infiltration . During periapical inflammation, immune cells migrate to the periapical area, where they release pro-inflammatory cytokines such as tumor necrosis factor-alpha (TNF-α), along with anti-inflammatory cytokines like interleukin-10 (IL-10). These cytokines play crucial roles in modulating inflammation and tissue repair. MicroRNAs (miRNAs) are evolutionarily conserved small (18-22 nucleotides) single-stranded, noncoding RNAs. It has been well acknowledged that miRNAs influence gene expression at the posttranscriptional level by targeting mRNA 3'-untranslated regions (3'-UTRs). Accumulating evidence has suggested that miRNA expression is related to the clinical and biological features of diverse diseases, and they can be potential biomarkers for diagnosis, treatment, and prognosis. miRNAs have revealed their critical roles in regulating various cellular functions, including proliferation, apoptosis, differentiation, metabolism, and tumorigenesis, by targeting specific mRNAs. MiR-146a regulates innate immunity, inflammatory responses, and the antiviral pathway. Changes in miR-146a expression have been noted in many human diseases, including autoimmune disorders and cancers. In addition, miR-146a is an important biomarker of disease diagnosis, prevention, and treatment. It is a negative regulator of inflammatory responses by suppressing target gene expression. However, limited data is available regarding the functional role of miR-146a in modulating the inflammatory response of periapical tissues following root canal disinfection in endodontic retreatment cases. Eliminating microorganisms is the primary objective of root canal therapy in order to create an environment as free of bacteria as possible. However, not all root canal treatments are completely successful, and in some cases, the infection persists leading to development of secondary apical periodontitis in previously treated teeth. Disinfecting the root canal during retreatment is significantly more challenging due to the presence of persistent microorganisms that have settled in the root canal system. These microbes are often resistant to standard irrigations and antimicrobial agents leading to the formation of periradicular lesions. Such bacteria can survive for extended periods around the previously filled root canals. Sodium hypochlorite (NaOCl) is the most widely used irrigant in root canal therapy due to its strong antibacterial effect and its ability to dissolve organic substances. Effective canal cleaning is difficult to achieve without the use of NaOCl at a sufficiently high concentration. However, NaOCl has several drawbacks, including its cytotoxicity which can lead to tissue damage and patient symptoms. Additionally, its strong oxidizing nature negatively affects the mechanical properties of dentin such as microhardness and elastic modulus. NaOCl should be used with caution in endodontic procedures to prevent hypochlorite accidents. Calcium hydroxide (Ca (OH)2) is the most widely utilized intracanal medication. It has the potential to dissolve tissue, acts as a physical barrier and generates hydroxyl ions, creating an extremely alkaline environment. It has been shown to be quite effective in the treatment of teeth with persistent periapical lesions. To provide optimal endodontic treatment, the root canal system should be thoroughly cleaned of soft-tissue debris, smear layer, and bacteria. Nanoparticles (NPs) have unique characteristics such as smaller sizes, increased surface area to volume ratio, and higher chemical reactivity and charge density leading to greater interaction with the environment and negatively charged bacterial cells, compared to their bulk counterparts. These advantages can be used to design highly anti-microbial agents with maximal therapeutic efficacy and minimal side effects.

Conditions

Post-operative Pain; Periapical Inflammation

Keywords

Periapical Inflammation; Nano-Calcium Hydroxide; Nano-Chitosan; Endodontic Retreatment

Outcome Measures

Primary Outcomes (1)

• IL-10 and TNF-α levels

  IL-10 and TNF-α levels will be quantified using ELISA kit from periapical fluid samples according to manufacturer instructions and regulatory miR-146a will be quantified using Real-time PCR

  1 week

Secondary Outcomes (2)

• Periapical cytological smear

  1 week

• Postoperative pain assessment

  1 week

Study Arms (3)

Group I: Nanochitosan paste

EXPERIMENTAL

Intracanal medicament will be placed in the canal, 1 mm shorter than the working length using the applicator tip and left for 1 week.

Drug: Nanochitosan paste

Group II: Nano-calcium hydroxide paste

EXPERIMENTAL

Intracanal medicament will be placed in the canal, 1 mm shorter than the working length using the applicator tip and left for 1 week.

Drug: Nano-calcium hydroxide paste

Group III: Calcium hydroxide paste

EXPERIMENTAL

Intracanal medicament will be placed in the canal, 1 mm shorter than the working length using the applicator tip and left for 1 week.

Drug: Calcium hydroxide paste

Interventions

Nanochitosan paste DRUG

Nanochitosan paste (Nanogate company, Cairo, Egypt)

Group I: Nanochitosan paste

Nano-calcium hydroxide paste DRUG

Nano-calcium hydroxide paste (Nanogate company, Cairo, Egypt),

Group II: Nano-calcium hydroxide paste

Calcium hydroxide paste DRUG

Calcium hydroxide paste (MetaBiomed, Chungcheongbuk-do, Korea)

Group III: Calcium hydroxide paste

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Male patients of age range between 20 and 40 years old
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients have single rooted teeth with root canal form type I. Have previous endodontic therapy with failure. Have periapical radiolucency (PAI score of 3 or 4). Asymptomatic patients who had no pain or swelling, had a negative response to palpation and percussion.

You may not qualify if:

• Patients who had received antibiotic therapy within the past 3 months. Pregnancy and lactation. Systemic disease. Physical or mental disability. Non-restorable teeth. Any signs of resorption, immature roots, fracture, sinus tract and dental anomaly

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al Azhar University

Cairo, Nasr City, 11765, Egypt

RECRUITING

Related Publications (4)

• Cicek E, Koçak MM, Kocak S, Saglam BC, Turker SA. Postoperative pain intensity after using different instrumentation techniques: a randomized clinical study. J Appl Oral Sci. 2017; 25: 20-6.

  BACKGROUND

• Zand V, Mokhtari H, Hasani A, Jabbari G. Comparison of the penetration depth of conventional and nano-particle calcium hydroxide into dentinal tubules. Iran Endod J 2017;12: 366-70.

  BACKGROUND

• Waltimo T, Trope M, Haapasalo M, Orstavik D. Clinical efficacy of treatment procedures in endodontic infection control and one-year follow-up of periapical healing. J Endod 2005; 31:863-6.

  BACKGROUND

• Shrestha A, Kishen A. Antibacterial nanoparticles in endodontics: A systemic review. J Endod 2016; 42:1417-26.

  BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Sabah Morad Sobhy, PHD

CONTACT

+201096529143; sabamorad@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endodontic department, al azhar university. principal investigator

Study Record Dates

• First Submitted: March 15, 2026
• First Posted: May 6, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 30, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)