Acute Apical AbscessCAM-AAANCT07819240
Antibacterial Effects of Intracanal Medicaments in Acute Apical Abscesses
A study testing Calcium Hydroxide Intracanal Medicament and Calcium Silicate-Based Intracanal Medicament in people with Acute Apical Abscess, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Apical Abscess
- What is being tested?
- Calcium Hydroxide Intracanal Medicament and Calcium Silicate-Based Intracanal Medicament
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2025to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- American Society of Anesthesiologists physical status classification I (ASA I)
- Provision of written informed consent
Who cannot join
- Previous endodontic treatment of the affected tooth
- Periodontal probing depth greater than 4 mm
- History of trauma involving the affected tooth
- Pregnancy or breastfeeding
- Immunodeficiency
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ataturk University Faculty of Dentistry
Erzurum, Erzurum, 25240
Halit Aladağ, DDS, PhD, +905414675965, haladag@atauni.edu.tr
About this study
Official title: Comparative Evaluation of the Antibacterial Efficacy of Calcium Hydroxide and a Calcium Silicate-Based Intracanal Medicament in Teeth With Acute Apical Abscesses Using Real-Time PCR: A Randomized Clinical 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.
Read the detailed description
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.
- Conditions
- Acute Apical Abscess
- Being tested
- Calcium Hydroxide Intracanal Medicament, Calcium Silicate-Based Intracanal Medicament
- Keywords
- Endodontic Infection, Root Canal Treatment, Intracanal Medicament, Calcium Hydroxide, Calcium Silicate, Real-Time PCR, Bacterial Load
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium Hydroxide Intracanal MedicamentOther
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 MedicamentOther
Calcium silicate-based intracanal medicament placed into the prepared root canal to 1 mm short of the working length for 7 to 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Calcium Hydroxide Group | Active comparator | 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. Receives: Other: Calcium Hydroxide Intracanal Medicament |
| Calcium Silicate-Based Medicament Group | Experimental | 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. Receives: Other: Calcium Silicate-Based Intracanal Medicament |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From immediately after chemomechanical preparation to 7 to 10 days after intracanal medicament placement
Secondary outcomes (2)
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.
Measured: 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.
Measured: From before to immediately after chemomechanical root canal preparation during the first treatment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start15 Sep 2025
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Apical AbscessStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned in parallel to receive either a calcium hydroxide or a calcium silicate-based intracanal medicament.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halit Aladağ, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819240
- Sponsor's protocol ID
- ATAUNI-ENDO-AAA-01
- Other IDs
- 16653
- Acronym
- CAM-AAA
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of the Antibacterial Efficacy of Calcium Hydroxide and a Calcium Silicate-Based Intracanal Medicament in Teeth With Acute Apical Abscesses Using Real-Time PCR: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07819240
- Acronym / sponsor ID
- CAM-AAA / ATAUNI-ENDO-AAA-01
- Conditions
- Acute Apical Abscess
- Keywords
- Endodontic Infection, Root Canal Treatment, Intracanal Medicament, Calcium Hydroxide, Calcium Silicate, Real-Time PCR, Bacterial Load
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned in parallel to receive either a calcium hydroxide or a calcium silicate-based intracanal medicament.
| Arm | Type | Receives |
|---|---|---|
| Calcium Hydroxide Group | Active comparator | Other: Calcium Hydroxide Intracanal MedicamentAfter 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. |
| Calcium Silicate-Based Medicament Group | Experimental | Other: Calcium Silicate-Based Intracanal MedicamentAfter 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- American Society of Anesthesiologists physical status classification I (ASA I)
Key exclusion criteria (5 listed)
- Previous endodontic treatment of the affected tooth
- Periodontal probing depth greater than 4 mm
- History of trauma involving the affected tooth
- Pregnancy or breastfeeding
- Immunodeficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium Hydroxide Intracanal MedicamentCalcium hydroxide-based intracanal medicament placed into the prepared root canal to 1 mm short of the working length for 7 to 10 days. | Other | Calcium Hydroxide Group |
| Calcium Silicate-Based Intracanal MedicamentCalcium silicate-based intracanal medicament placed into the prepared root canal to 1 mm short of the working length for 7 to 10 days. | Other | Calcium Silicate-Based Medicament Group |
Primary outcome
Change in Total Bacterial Load After Intracanal Medication
Time frame: From immediately after chemomechanical preparation to 7 to 10 days after intracanal medicament placement
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.
2 secondary outcomes
Changes in the Levels of Selected Endodontic Bacterial Species
Time frame: From before chemomechanical preparation to 7 to 10 days after intracanal medicament placement
Change in Total Bacterial Load After Chemomechanical Preparation
Time frame: From before to immediately after chemomechanical root canal preparation during the first treatment visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
Related trials for Acute Apical Abscess
Not yet recruiting
Using Platelet-rich Fibrin in Regenerative Endodontic Treatment in Mature Permanent Teeth
Chronic Apical Periodontitis, Necrosis of Pulp
RecruitingPhase 2
Valacyclovir in Pain Management of Acute Apical Abscesses
Acute Apical Abscess, Pain, Acute
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium Hydroxide Intracanal Medicament and Calcium Silicate-Based Intracanal Medicament in people with Acute Apical Abscess, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Bacterial Load After Intracanal Medication (time frame: From immediately after chemomechanical preparation to 7 to 10 days after intracanal medicament placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.