Apical PeriodontitisNCT07351682
Antibacterial Activity of Calcium Hydroxide and Betamethasone in Apical Periodontitis
A study testing Calcium Hydroxide (Ca(OH)2) Intracanal Medication, Calcium Hydroxide + Iodoform (Metapex) and Calcium Hydroxide + Betamethasone in people with Apical Periodontitis, run by Medipol University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Apical Periodontitis
- What is being tested?
- Calcium Hydroxide (Ca(OH)2) Intracanal Medication, Calcium Hydroxide + Iodoform (Metapex) and Calcium Hydroxide + Betamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 2 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- - 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University Faculty of Dentistry
Istanbul, Istanbul, 34810
About this study
Official title: Antibacterial Efficacy of Calcium Hydroxide Used Alone or in Combination With Iodoform (Metapex) and Steroid (Betamethasone) in Patients With Apical Periodontitis
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.
Read the detailed description
Apical periodontitis is a chronic inflammatory condition of periapical tissues that develops as a result of persistent bacterial infection within the root canal system. While chemomechanical preparation significantly reduces the microbial load, bacteria may remain in anatomical complexities such as dentinal tubules, isthmuses, and apical ramifications. For this reason, intracanal medicaments are widely used between treatment sessions to enhance disinfection and improve treatment outcomes.
Calcium hydroxide is the most frequently used intracanal medicament due to its high pH and antibacterial properties. Nevertheless, certain microorganisms, particularly Enterococcus faecalis, have been shown to survive in alkaline environments, limiting the effectiveness of calcium hydroxide when used alone. To overcome this limitation, calcium hydroxide has been combined with various agents, including iodoform and corticosteroids, with the aim of enhancing antibacterial activity and reducing periapical inflammation.
Droplet digital PCR (ddPCR) is a novel molecular technique that enables absolute quantification of bacterial DNA without the need for standard curves and is less affected by PCR inhibitors compared to conventional quantitative PCR methods. Despite its advantages, the use of ddPCR in clinical endodontic research remains limited, particularly in in vivo studies evaluating intracanal medicaments.
This prospective, single-center clinical study aims to compare the antibacterial efficacy of three intracanal medicament protocols in patients with apical periodontitis undergoing endodontic retreatment: (1) calcium hydroxide alone, (2) calcium hydroxide combined with iodoform (Metapex), and (3) calcium hydroxide combined with betamethasone. Root canal samples will be collected at different treatment stages, and total bacterial load as well as Enterococcus faecalis levels will be quantified using ddPCR.
The findings of this study are expected to provide high-quality clinical evidence regarding the antibacterial effectiveness of commonly used intracanal medicaments and their combinations. The results may contribute to evidence-based decision-making in the selection of intracanal medicaments for the management of apical periodontitis, particularly in retreatment cases.
- Conditions
- Apical Periodontitis
- Being tested
- Calcium Hydroxide (Ca(OH)2) Intracanal Medication, Calcium Hydroxide + Iodoform (Metapex), Calcium Hydroxide + Betamethasone
- Keywords
- Betamethasone, Calcium Hydroxide, Enterococcus faecalis, Droplet Digital PCR, Retreatment
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium Hydroxide (Ca(OH)2) Intracanal MedicationOther
In the Ch Groups CaOH was prepared and inserted into the canal by using lentülo spirals.
Calcium Hydroxide + Iodoform (Metapex)Other
Mixture of CaOH and Iodoform was inserted into the canal by using lentulo spirals.
Calcium Hydroxide + BetamethasoneOther
Mixture of CaOH and bethamethasone was inserted into the canal by using lentulo spirals.
| Study group | Role | What they receive |
|---|---|---|
| Calcium Hydroxide | Experimental | 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. Receives: Other: Calcium Hydroxide (Ca(OH)2) Intracanal Medication |
| Calcium Hydroxide + Iodoform (Metapex) | Experimental | 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. Receives: Other: Calcium Hydroxide + Iodoform (Metapex) |
| Calcium Hydroxide + Betamethasone | Experimental | 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. Receives: Other: Calcium Hydroxide + Betamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From baseline to 7 days after intracanal medicament application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Jan 2026
- Primary completion30 Aug 2026
- Study completion2 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical PeriodontitisStudies of the same condition, open and under way.
- More trials run by Medipol 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Medipol University Scientific Research Projects Commission
- Responsible party
- Principal investigator, Duygu Degirmencioglu, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351682
- Sponsor's protocol ID
- MedipolU-629
- Status last verified
- Oct 2026
- First submitted
- 10 Jan 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibacterial Efficacy of Calcium Hydroxide Used Alone or in Combination With Iodoform (Metapex) and Steroid (Betamethasone) in Patients With Apical Periodontitis
- ClinicalTrials.gov ID
- NCT07351682
- Acronym / sponsor ID
- MedipolU-629
- Conditions
- Apical Periodontitis
- Keywords
- Betamethasone, Calcium Hydroxide, Enterococcus faecalis, Droplet Digital PCR, Retreatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Collaborators
- Istanbul Medipol University Scientific Research Projects Commission
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Aug 2026 (actual)
- Study completion
- 2 Sep 2026 (actual)
- First posted
- 20 Jan 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.
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.
Detailed description
Apical periodontitis is a chronic inflammatory condition of periapical tissues that develops as a result of persistent bacterial infection within the root canal system. While chemomechanical preparation significantly reduces the microbial load, bacteria may remain in anatomical complexities such as dentinal tubules, isthmuses, and apical ramifications. For this reason, intracanal medicaments are widely used between treatment sessions to enhance disinfection and improve treatment outcomes.
Calcium hydroxide is the most frequently used intracanal medicament due to its high pH and antibacterial properties. Nevertheless, certain microorganisms, particularly Enterococcus faecalis, have been shown to survive in alkaline environments, limiting the effectiveness of calcium hydroxide when used alone. To overcome this limitation, calcium hydroxide has been combined with various agents, including iodoform and corticosteroids, with the aim of enhancing antibacterial activity and reducing periapical inflammation.
Droplet digital PCR (ddPCR) is a novel molecular technique that enables absolute quantification of bacterial DNA without the need for standard curves and is less affected by PCR inhibitors compared to conventional quantitative PCR methods. Despite its advantages, the use of ddPCR in clinical endodontic research remains limited, particularly in in vivo studies evaluating intracanal medicaments.
This prospective, single-center clinical study aims to compare the antibacterial efficacy of three intracanal medicament protocols in patients with apical periodontitis undergoing endodontic retreatment: (1) calcium hydroxide alone, (2) calcium hydroxide combined with iodoform (Metapex), and (3) calcium hydroxide combined with betamethasone. Root canal samples will be collected at different treatment stages, and total bacterial load as well as Enterococcus faecalis levels will be quantified using ddPCR.
The findings of this study are expected to provide high-quality clinical evidence regarding the antibacterial effectiveness of commonly used intracanal medicaments and their combinations. The results may contribute to evidence-based decision-making in the selection of intracanal medicaments for the management of apical periodontitis, particularly in retreatment cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Calcium Hydroxide | Experimental | Other: Calcium Hydroxide (Ca(OH)2) Intracanal MedicationThis 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) | Experimental | Other: 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 | Experimental | Other: Calcium Hydroxide + BetamethasoneThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- - 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.
Key exclusion criteria (5 listed)
- 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.
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 (Ca(OH)2) Intracanal MedicationIn the Ch Groups CaOH was prepared and inserted into the canal by using lentülo spirals. | Other | Calcium Hydroxide |
| Calcium Hydroxide + Iodoform (Metapex)Mixture of CaOH and Iodoform was inserted into the canal by using lentulo spirals. | Other | Calcium Hydroxide + Iodoform (Metapex) |
| Calcium Hydroxide + BetamethasoneMixture of CaOH and bethamethasone was inserted into the canal by using lentulo spirals. | Other | Calcium Hydroxide + Betamethasone |
Primary outcome
Change in Total Bacterial Load in Root Canal Samples
Time frame: From baseline to 7 days after intracanal medicament application
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.
1 secondary outcome
Change in Enterococcus faecalis Levels
Time frame: From baseline to 7 days after intracanal medicament application
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 (Ca(OH)2) Intracanal Medication, Calcium Hydroxide + Iodoform (Metapex) and Calcium Hydroxide + Betamethasone in people with Apical Periodontitis, run by Medipol 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 4 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: finished, as of the sponsor's last update on 28 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Bacterial Load in Root Canal Samples (time frame: From baseline to 7 days after intracanal medicament application). 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 28 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.