An interventional study of Calcium Hydroxide Intracanal Medicament and Calcium Silicate-Based Intracanal Medicament in Acute Apical Abscess, sponsored by Ataturk University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Ataturk University · Not applicable, Interventional, and Treatment
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.
Acute apical abscess is an endodontic infection characterized by localized inflammation, pain, swelling, and purulent exudate. Although chemomechanical root canal preparation substantially reduces the bacterial load, microorganisms may remain within the root canal system. Intracanal medicaments are therefore used between treatment sessions to improve microbial reduction.
In this randomized, parallel-group clinical trial, teeth diagnosed with acute apical abscess are allocated to receive either a calcium hydroxide intracanal medicament or a calcium silicate-based intracanal medicament. All teeth undergo standardized root canal treatment and irrigation procedures.
Microbiological samples are collected at three main treatment stages: before chemomechanical preparation, after chemomechanical preparation and irrigation, and after a 7- to 10-day intracanal medication period. Bacterial DNA is analyzed using SYBR Green Real-Time PCR. Universal 16S rRNA primers are used to quantify the total bacterial load. Selected bacterial species associated with endodontic infections are also evaluated.
The primary outcome is the change in total bacterial load between the post-instrumentation sample and the sample collected after intracanal medication. Secondary outcomes include changes in selected bacterial species and bacterial levels across the different sampling stages. The study aims to determine and compare the microbial effectiveness of the two intracanal medicaments in acute apical abscess cases.
152 studies on the registry are indexed under Abscess; 22 are open to participants now.
This study's planned enrollment of 56 is below the median of 110 across 120 interventional studies indexed under Abscess.
Browse Abscess studies →Ataturk University is the lead sponsor of 458 studies on the registry; 124 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
After standardized chemomechanical root canal preparation, a calcium hydroxide-based intracanal medicament is placed into the root canal to 1 mm short of the working length and remains in the canal for 7 to 10 days.
Other: Calcium Hydroxide Intracanal Medicament
After standardized chemomechanical root canal preparation, a calcium silicate-based intracanal medicament is placed into the root canal to 1 mm short of the working length and remains in the canal for 7 to 10 days.
Other: Calcium Silicate-Based Intracanal Medicament
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 placed into the prepared root canal to 1 mm short of the working length for 7 to 10 days.
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
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
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
Plan to share: No — Individual participant data will not be shared.
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