Antibacterial Activity of Calcium Hydroxide and Betamethasone in Apical Periodontitis

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorDuygu Degirmencioglu

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

- 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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

45 Participants
are grouped into 3 trial groups
Group A: Calcium Hydroxide
Group B: Calcium Hydroxide + Iodoform (Metapex)
Group C: Calcium Hydroxide + Betamethasone

Trial outcomes

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.

Time frame
From baseline to 7 days after intracanal medicament application

Secondary outcomes

1

Change in Enterococcus faecalis Levels

This secondary outcome assesses the change in Enterococcus faecalis levels in root canal samples collected during endodontic retreatment. Enterococcus faecalis DNA will be quantified using droplet digital PCR (ddPCR) by measuring absolute DNA copy numbers before and after intracanal medicament application.

Time frame
From baseline to 7 days after intracanal medicament application

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duygu Degirmencioglu

Lead sponsor

Medipol University

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: