Antibacterial AgentsNCT06779370
Effect of Calcium Silicate-Based Root Canal Medicament After Retreatment
A study testing Calcium Silicate and Calcium hydroxide in people with Antibacterial Agents and Postoperative Dental Pain, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Calcium hydroxide is generally preferred in endodontics as an intracanal medicament due to its antimicrobial and biological effects. However, the antimicrobial effect of calcium hydroxide is limited. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Antibacterial Agents, Postoperative Dental Pain, Antifungal Agents
- What is being tested?
- Calcium Silicate and Calcium hydroxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jun 2024to 10 Jan 2025
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy patients with aged between 18-60.
- Incisor, canine, and premolar teeth that had previously undergone root canal treatment
- Incisor, canine, and premolar teeth with a diagnosis of chronic apical abscess or asymptomatic apical periodontitis
- teeth with only 1 root canal
- the patients had not used any antibiotics for 3 months before treatment
Who cannot join
- the presence of a root fracture
- teeth with any swelling
- ankyloses,
- periodontal pockets deeper than 4 mm.
- teeth which a rubber dam could not be performed
- patients with allergy to ibuprofen or ciprofloxacin were also excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Calcium Silicate-Based Root Canal Medicament on Antifungal-Antibacterial Activity and Post-Operative Pain After Retreatment
Calcium hydroxide is generally preferred in endodontics as an intracanal medicament due to its antimicrobial and biological effects. However, the antimicrobial effect of calcium hydroxide is limited. A new calcium silicate-based root canal medicament has been developed as an alternative to calcium hydroxide-based medicaments.
The aim of this study was to investigate the effects of calcium silicate-based root canal medicament on antibacterial, antifungal activity, and postoperative pain in root canal-treated teeth with periapical lesions.
Read the detailed description
Sixty patients were randomly divided into two groups using a web-based program according to the selected medicament (calcium silicate-based root canal medicament or calcium hydroxide-based root canal medicament).
After the removal of gutta-percha from the root canals, the first samples were collected using paper points to evaluate antibacterial and antifungal effects. The root canals were then chemomechanically prepared, followed by final irrigation activation, and the second samples were collected. The selected root canal medicament was placed in the canals, and the patients were given a form to record their postoperative pain levels over one week.
At the second appointment, the medicaments were removed, and third samples were collected using paper points to assess antibacterial and antifungal effects. The root canal treatments of the patients were then completed. The antibacterial and antifungal effects of the medicaments were evaluated using PCR, and the patients' postoperative pain levels were recorded using follow-up forms.
- Being tested
- Calcium Silicate, Calcium hydroxide
- Keywords
- calcium silicate based root canal medicament, calcium hydroxide based root canal medicament, bacterial load, antibacterial effect, antifungal effect, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium SilicateDrug
Also called calcium silicate based medicament group
Root canal filling was removed with endodontic file. Sterile paper points were placed at working length to assess antibacterial and antifungal effects before the medicament was placed. Subsequently, the root canals were chemomechanically prepared, final irrigation activation was performed, and second samples were collected in the same manner. The calcium silicate-based root canal medicament was placed in the canals, and the teeth were sealed with temporary fillings. A form was provided to evaluate the patients' postoperative pain levels over one week. At the second appointment, the medicament was removed, and third samples were collected to assess antibacterial effects. The root canal treatments of the patients were completed. The antibacterial and antifungal effects of the medicaments were evaluated using PCR, and the patients' postoperative pain levels were recorded using follow-up forms.
Calcium hydroxideDrug
Root canal filling was removed with endodontic file. Sterile paper points were placed at working length to assess antibacterial and antifungal effects before the medicament was placed. Subsequently, the root canals were chemomechanically prepared, final irrigation activation was performed, and second samples were collected in the same manner. The calcium hydroxide-based root canal medicament was placed in the canals, and the teeth were sealed with temporary fillings. A form was provided to evaluate the patients' postoperative pain levels over one week. At the second appointment, the medicament was removed, and third samples were collected to assess antibacterial effects. The root canal treatments of the patients were completed. The antibacterial and antifungal effects of the medicaments were evaluated using PCR, and the patients' postoperative pain levels were recorded using follow-up forms.
| Study group | Role | What they receive |
|---|---|---|
| calcium silicate based medicament | Experimental | Root canal lengths were determined using an electronic apex locator and a 15-K file. R25 Reciproc files were used at working lengths to remove the root canal filling. During instrumentation, the root canals were irrigated with saline solution. To obtain the first samples, three sterile paper points were placed at working length and the samples were transferred to an Eppendorf tube containing distilled water.
Subsequently, the root canals were chemomechanically prepared, final irrigation activation was performed, and the second samples were collected in the same manner. The calcium silicate-based root canal medicament was placed in the canals, and the teeth were sealed with temporary fillings. A form was provided to assess the patients' postoperative pain levels over one week.
At the second appointment, the medicament was removed, and third samples were collected using paper points with the same technique to evaluate antibacterial and antifungal effects. The root canal treatments of Receives: Drug: Calcium Silicate |
| calcium hydroxide based medicament | Active comparator | Root canal lengths were determined using an electronic apex locator and a 15-K file. R25 Reciproc files were used at working lengths to remove the root canal filling. During instrumentation, the root canals were irrigated with saline solution. To obtain the first samples, three sterile paper points were placed at working length and the samples were transferred to an Eppendorf tube containing distilled water.
Subsequently, the root canals were chemomechanically prepared, final irrigation activation was performed, and the second samples were collected in the same manner. The calcium hydroxide based root canal medicament was placed in the canals, and the teeth were sealed with temporary fillings. A form was provided to assess the patients' postoperative pain levels over one week.
At the second appointment, the medicament was removed, and third samples were collected using paper points with the same technique to evaluate antibacterial and antifungal effects. The root canal treatments of Receives: Drug: Calcium hydroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
preoperative and postoperative levels of bacterial loud
The amounts of antibacterial loud was measured using a PCR kit.
Measured: one week
preoperative and postoperative levels of antifungal loud
The amounts of antifungal loud was measured using a PCR kit.
Measured: one week
postoperative pain levels
postoperative pain levels will be describe using the visual analog scale (VAS). The VAS was classified using the following scale [15]: no pain (0); mild pain (1-3); moderate pain (4-6), and severe pain (7-10).
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start12 Jun 2024
- Primary completion12 Dec 2024
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antibacterial AgentsStudies 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
- two groups: group 1 calcium hydroxide based medicament (control group) group 2: calcium silicate based medicament
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Sümbüllü, Ataturk University
- Investigators
- meltem SÜMBÜLLÜ, DDS, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779370
- Sponsor's protocol ID
- 14244
- Status last verified
- Jan 2025
- First submitted
- 12 Jan 2025
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mentes I, Sumbullu M. Effect of tricalcium silicate-based intracanal dressing on antibacterial-antifungal activity and postoperative pain intensity after non-surgical endodontic retreatment: randomized controlled clinical trial. Head Face Med. 2025 Nov 21;21(1):78. doi: 10.1186/s13005-025-00559-w.
PubMed 41272686
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Calcium Silicate-Based Root Canal Medicament on Antifungal-Antibacterial Activity and Post-Operative Pain After Retreatment
- ClinicalTrials.gov ID
- NCT06779370
- Acronym / sponsor ID
- 14244
- Keywords
- calcium silicate based root canal medicament, calcium hydroxide based root canal medicament, bacterial load, antibacterial effect, antifungal effect, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 16 Jan 2025 (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.
Calcium hydroxide is generally preferred in endodontics as an intracanal medicament due to its antimicrobial and biological effects. However, the antimicrobial effect of calcium hydroxide is limited. A new calcium silicate-based root canal medicament has been developed as an alternative to calcium hydroxide-based medicaments.
The aim of this study was to investigate the effects of calcium silicate-based root canal medicament on antibacterial, antifungal activity, and postoperative pain in root canal-treated teeth with periapical lesions.
Detailed description
Sixty patients were randomly divided into two groups using a web-based program according to the selected medicament (calcium silicate-based root canal medicament or calcium hydroxide-based root canal medicament).
After the removal of gutta-percha from the root canals, the first samples were collected using paper points to evaluate antibacterial and antifungal effects. The root canals were then chemomechanically prepared, followed by final irrigation activation, and the second samples were collected. The selected root canal medicament was placed in the canals, and the patients were given a form to record their postoperative pain levels over one week.
At the second appointment, the medicaments were removed, and third samples were collected using paper points to assess antibacterial and antifungal effects. The root canal treatments of the patients were then completed. The antibacterial and antifungal effects of the medicaments were evaluated using PCR, and the patients' postoperative pain levels were recorded using follow-up forms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- two groups: group 1 calcium hydroxide based medicament (control group) group 2: calcium silicate based medicament
| Arm | Type | Receives |
|---|---|---|
| calcium silicate based medicament | Experimental | Drug: Calcium SilicateRoot canal lengths were determined using an electronic apex locator and a 15-K file. R25 Reciproc files were used at working lengths to remove the root canal filling. During instrumentation, the root canals were irrigated with saline solution. To obtain the first samples, three sterile paper points were placed at working length and the samples were transferred to an Eppendorf tube containing distilled water. Subsequently, the root canals were chemomechanically prepared, final irrigation activation was performed, and the second samples were collected in the same manner. The calcium silicate-based root canal medicament was placed in the canals, and the teeth were sealed with temporary fillings. A form was provided to assess the patients' postoperative pain levels over one week. At the second appointment, the medicament was removed, and third samples were collected using paper points with the same technique to evaluate antibacterial and antifungal effects. The root canal treatments of |
| calcium hydroxide based medicament | Active comparator | Drug: Calcium hydroxideRoot canal lengths were determined using an electronic apex locator and a 15-K file. R25 Reciproc files were used at working lengths to remove the root canal filling. During instrumentation, the root canals were irrigated with saline solution. To obtain the first samples, three sterile paper points were placed at working length and the samples were transferred to an Eppendorf tube containing distilled water. Subsequently, the root canals were chemomechanically prepared, final irrigation activation was performed, and the second samples were collected in the same manner. The calcium hydroxide based root canal medicament was placed in the canals, and the teeth were sealed with temporary fillings. A form was provided to assess the patients' postoperative pain levels over one week. At the second appointment, the medicament was removed, and third samples were collected using paper points with the same technique to evaluate antibacterial and antifungal effects. The root canal treatments of |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- healthy patients with aged between 18-60.
- Incisor, canine, and premolar teeth that had previously undergone root canal treatment
- Incisor, canine, and premolar teeth with a diagnosis of chronic apical abscess or asymptomatic apical periodontitis
- teeth with only 1 root canal
- the patients had not used any antibiotics for 3 months before treatment
Key exclusion criteria (6 listed)
- the presence of a root fracture
- teeth with any swelling
- ankyloses,
- periodontal pockets deeper than 4 mm.
- teeth which a rubber dam could not be performed
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 SilicateAlso: calcium silicate based medicament groupRoot canal filling was removed with endodontic file. Sterile paper points were placed at working length to assess antibacterial and antifungal effects before the medicament was placed. Subsequently, the root canals were chemomechanically prepared, final irrigation activation was performed, and second samples were collected in the same manner. The calcium silicate-based root canal medicament was placed in the canals, and the teeth were sealed with temporary fillings. A form was provided to evaluate the patients' postoperative pain levels over one week. At the second appointment, the medicament was removed, and third samples were collected to assess antibacterial effects. The root canal treatments of the patients were completed. The antibacterial and antifungal effects of the medicaments were evaluated using PCR, and the patients' postoperative pain levels were recorded using follow-up forms. | Drug | calcium silicate based medicament |
| Calcium hydroxideRoot canal filling was removed with endodontic file. Sterile paper points were placed at working length to assess antibacterial and antifungal effects before the medicament was placed. Subsequently, the root canals were chemomechanically prepared, final irrigation activation was performed, and second samples were collected in the same manner. The calcium hydroxide-based root canal medicament was placed in the canals, and the teeth were sealed with temporary fillings. A form was provided to evaluate the patients' postoperative pain levels over one week. At the second appointment, the medicament was removed, and third samples were collected to assess antibacterial effects. The root canal treatments of the patients were completed. The antibacterial and antifungal effects of the medicaments were evaluated using PCR, and the patients' postoperative pain levels were recorded using follow-up forms. | Drug | calcium hydroxide based medicament |
Primary outcome
preoperative and postoperative levels of bacterial loud
Time frame: one week
The amounts of antibacterial loud was measured using a PCR kit.
preoperative and postoperative levels of antifungal loud
Time frame: one week
The amounts of antifungal loud was measured using a PCR kit.
postoperative pain levels
Time frame: one week
postoperative pain levels will be describe using the visual analog scale (VAS). The VAS was classified using the following scale [15]: no pain (0); mild pain (1-3); moderate pain (4-6), and severe pain (7-10).
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 16 Jan 2025.
- Derived from this study: PubMed 41272686Mentes I, Sumbullu M. Effect of tricalcium silicate-based intracanal dressing on antibacterial-antifungal activity and postoperative pain intensity after non-surgical endodontic retreatment: randomized controlled clinical trial. Head Face Med. 2025 Nov 21;21(1):78. doi: 10.1186/s13005-025-00559-w.
- 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.
meltem SÜMBÜLLÜ, DDS principal investigator
Ataturk University
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 Silicate and Calcium hydroxide in people with Antibacterial Agents and Postoperative Dental Pain, 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 5 inclusion and 6 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 16 Jan 2025. 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?
preoperative and postoperative levels of bacterial loud (time frame: one week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06779370, which also lists 1 linked publication.
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 16 Jan 2025.