Actively Recruiting

Phase Not Applicable
Age: 20Years - 40Years
MALE
ID07571837

Modulation of Periapical Inflammation Following Nano-Calcium Hydroxide and Nano-Chitosan Intracanal Medications in Endodontic Retreatment Cases: A Randomized Controlled Clinical Trial

Led by Al-Azhar University · Updated on 2026-05-06

63

Participants Needed

1

Research Sites

2 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating how different intracanal medications affect inflammation in teeth that need retreatment due to persistent infection after root canal therapy. The study focuses on periapical inflammation, a common issue where immune responses cause tissue and bone changes around the tooth root. Small molecules called microRNAs, especially miR-146a, may play a role in controlling this inflammation, but more data is needed on their function after root canal disinfection. Participants are randomly assigned to one of three groups, each receiving a different intracanal medication: nanochitosan paste, nano-calcium hydroxide paste, or regular calcium hydroxide paste. After cleaning the root canal with specialized tools and irrigation solutions, the assigned medication is placed inside the canal for one week. The procedure includes local anesthesia, infection control steps, and temporary sealing of the tooth. After one week, the medication is removed, samples are collected, and the tooth is permanently filled. During the study, patients will undergo multiple assessments including microbiological sampling and measurement of inflammatory markers like IL-10 and TNF-b1 after one week. Pain levels and cellular changes in the periapical area are also monitored. Safety is ensured through strict procedures and monitoring for any adverse events. Participation lasts about one week from medication placement to final evaluation, with follow-up and safety checks incorporated.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 20Years - 40Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients have single rooted teeth with root canal form type I
  • Previous endodontic therapy with failure
  • Presence of periapical radiolucency with PAI score of 3 or 4
  • Asymptomatic patients with no pain or swelling
  • Negative response to palpation and percussion tests
Not Eligible

You will not qualify if you...

  • Received antibiotic therapy within the past 3 months
  • Pregnancy or lactation
  • Presence of systemic disease
  • Physical or mental disability
  • Non-restorable teeth
  • Signs of resorption, immature roots, fracture, sinus tract, or dental anomaly

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 week

Participants receive intracanal medicament placed inside the root canal and left for 1 week to modulate periapical inflammation.

2 visits (in-person): one for medicament placement and one for removal and sampling

Trial Site Locations

Total: 1 location

1

Al Azhar University

Cairo, Nasr City, Egypt, 11765

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Research Team

S

Sabah Morad Sobhy, PHD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

Clinical efficacy of treatment procedures in endodontic infection control and one year follow-up of periapical healing.

Tuomas Waltimo, Martin Trope, Markus Haapasalo...

https://pubmed.ncbi.nlm.nih.gov/16306819