Antibacterial Activity of Calcium Hydroxide and Betamethasone in Apical Periodontitis

NCT07351682 | Not Yet Recruiting

• 1 other identifier: MedipolU-629
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Apical periodontitis is a chronic inflammatory disease caused by bacterial infection of the root canal system. Although mechanical cleaning and shaping reduce most microorganisms, bacteria may persist in areas that are difficult to reach, making the use of intracanal medicaments between treatment sessions clinically important. Calcium hydroxide is one of the most commonly used intracanal medicaments because of its antibacterial properties. However, some resistant microorganisms, such as Enterococcus faecalis, may survive when calcium hydroxide is used alone. Therefore, combining calcium hydroxide with other agents, such as iodoform or corticosteroids, may improve its antibacterial effectiveness. The purpose of this study is to compare the antibacterial activity of calcium hydroxide used alone or in combination with iodoform (Metapex) or betamethasone in patients with apical periodontitis. Bacterial load in root canals will be evaluated using droplet digital PCR (ddPCR), a highly sensitive molecular method that allows absolute quantification of bacteria. The results of this study are expected to provide evidence to support optimal intracanal medicament selection in endodontic retreatment cases.

Conditions

Apical Periodontitis

Keywords

Betamethasone; Calcium Hydroxide; Enterococcus faecalis; Droplet Digital PCR; Retreatment

Outcome Measures

Primary Outcomes (1)

• Change in Total Bacterial Load in Root Canal Samples

  The primary outcome is the change in total bacterial load in root canal samples collected during endodontic retreatment. Bacterial load will be quantified using droplet digital PCR (ddPCR) by measuring absolute bacterial DNA copy numbers at different treatment stages.

  From baseline to 7 days after intracanal medicament application

Secondary Outcomes (1)

• Change in Enterococcus faecalis Levels

  From baseline to 7 days after intracanal medicament application

Study Arms (3)

Calcium Hydroxide

This cohort includes patients with apical periodontitis undergoing endodontic retreatment who receive calcium hydroxide as an intracanal medicament as part of routine clinical care. The selection of the intracanal medicament is based on standard clinical decision-making and is not assigned by the study protocol.

Calcium Hydroxide + Iodoform (Metapex)

This cohort includes patients with apical periodontitis undergoing endodontic retreatment who receive a combination of calcium hydroxide and iodoform (Metapex) as an intracanal medicament as part of routine clinical care. The intracanal medicament is selected according to standard clinical practice and is not assigned by the study protocol.

Calcium Hydroxide + Betamethasone

This cohort includes patients with apical periodontitis undergoing endodontic retreatment who receive a combination of calcium hydroxide and betamethasone as an intracanal medicament as part of routine clinical care. The choice of intracanal medicament is determined by routine clinical decision-making and is not assigned by the study protocol.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients diagnosed with apical periodontitis who require endodontic retreatment and are treated at a single academic dental center.

You may qualify if:

• \- Adults aged 18 to 65 years.
• Patients diagnosed with apical periodontitis requiring endodontic retreatment.
• Presence of a single tooth with radiographic evidence of apical periodontitis.
• Ability to provide written informed consent.

You may not qualify if:

• Use of systemic antibiotics within the previous 3 months.
• Presence of systemic diseases that may affect healing or immune response.
• Pregnancy or lactation.
• Known allergy or hypersensitivity to any of the intracanal medicaments used.
• Teeth with acute abscess, severe periodontal disease, or root fractures.

Sponsors & Collaborators

• Duygu Degirmencioglu: lead

Study Sites (1)

Istanbul Medipol University Faculty of Dentistry

Istanbul, Istanbul, 34810, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Intracanal samples will be collected from root canals using sterile paper points during different stages of endodontic retreatment. The samples will contain microbial material from the root canal system and will be used for DNA extraction and molecular analysis. Specimens will be stored under appropriate laboratory conditions until droplet digital PCR (ddPCR) analysis is performed to quantify total bacterial load and Enterococcus faecalis levels.

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Duygu Degirmencioglu

Study Record Dates

• First Submitted: January 10, 2026
• First Posted: January 20, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)