Antibacterial Effects of Intracanal Medicaments in Acute Apical Abscesses

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAtaturk University

About this trial

This randomized clinical trial compares the antibacterial effects of calcium hydroxide and a calcium silicate-based intracanal medicament in teeth with acute apical abscesses. Microbiological samples are collected before root canal preparation, after chemomechanical preparation, and after intracanal medication. Bacterial levels are measured using Real-Time PCR. The main objective is to determine which intracanal medicament provides a greater reduction in the total bacterial load after a 7- to 10-day medication period.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of acute apical abscess

A single-rooted permanent tooth requiring primary endodontic treatment

Age between 18 and 65 years

No history of systemic disease

Disqualifiers

Previous endodontic treatment of the affected tooth

Periodontal probing depth greater than 4 mm

History of trauma involving the affected tooth

Pregnancy or breastfeeding

Trial design

Design model

Parallel

Treatments tested in this trial

  • Calcium Hydroxide Intracanal Medicament

    Other intervention

    Calcium hydroxide-based intracanal medicament placed into the prepared root canal to 1 mm short of the working length for 7 to 10 days.

  • Calcium Silicate-Based Intracanal Medicament

    Other intervention

    Calcium silicate-based intracanal medicament placed into the prepared root canal to 1 mm short of the working length for 7 to 10 days.

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: Calcium Hydroxide GroupActive comparator 1 intervention
Group B: Calcium Silicate-Based Medicament GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Total Bacterial Load After Intracanal Medication

Total bacterial load will be quantified using universal 16S rRNA gene-based Real-Time PCR in samples collected after chemomechanical root canal preparation (S2) and after the 7- to 10-day intracanal medication period (S3). The antibacterial effect will be evaluated as the change in log10 bacterial load from S2 to S3 and compared between the two intervention groups.

Time frame
From immediately after chemomechanical preparation to 7 to 10 days after intracanal medicament placement

Secondary outcomes

1

Changes in the Levels of Selected Endodontic Bacterial Species

The levels of Fusobacterium nucleatum, Prevotella intermedia, Porphyromonas endodontalis, Parvimonas micra, Treponema denticola, Streptococcus anginosus, Dialister pneumosintes, Campylobacter rectus, Filifactor alocis, and Olsenella uli will be evaluated using species-specific Real-Time PCR. Changes between the samples collected before chemomechanical preparation (S1), after chemomechanical preparation (S2), and after intracanal medication (S3) will be assessed and compared between the intervention groups.

Time frame
From before chemomechanical preparation to 7 to 10 days after intracanal medicament placement
2

Change in Total Bacterial Load After Chemomechanical Preparation

Total bacterial load will be quantified using universal 16S rRNA gene-based Real-Time PCR in samples collected before chemomechanical root canal preparation (S1) and immediately after chemomechanical preparation (S2). The change in log10 bacterial load from S1 to S2 will be evaluated to determine the bacterial reduction achieved by the standardized chemomechanical preparation protocol.

Time frame
From before to immediately after chemomechanical root canal preparation during the first treatment visit

Other outcomes

Sponsors and contacts

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