Root Canal TreatmentNCT07210177
The Success of Root Canal Treatments Performed Using Two Different Intracanal Medicaments
A study testing Bio-C Temp Intracanal Medication and Metapaste Intracanal Medication in people with Root Canal Treatment and Intracanal Medicament, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Previously untreated, asymptomatic, single-rooted maxillary anterior teeth with periapical lesions <5 mm, no fractures, resorption, calcification, or recent antibiotic use will performed two-visit root canal treatment. Initial radiographs will be taken. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Root Canal Treatment, Intracanal Medicament, Post Operative Pain
- What is being tested?
- Bio-C Temp Intracanal Medication and Metapaste Intracanal Medication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 1 Aug 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- with a non-contributory medical history, mature maxillary incisor teeth with periapical lesions, diagnosed as asymptomatic apical periodontitis
Who cannot join
- clinical symptoms, drainage, more than 5 mm loss of periodontal attachment, Teeth with periapical lesions larger than 5 mm previous endodontic treatment, non-restorable tooth patient with taken antibiotic or analgesics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Root Canal Treatments Performed Using Two Different Intracanal Medicaments
Previously untreated, asymptomatic, single-rooted maxillary anterior teeth with periapical lesions <5 mm, no fractures, resorption, calcification, or recent antibiotic use will performed two-visit root canal treatment. Initial radiographs will be taken. After rubber-dam isolation, working length will be determined; canals prepared step-back to size #40 with sodium hypochlorite (NaOCl) irrigation, rinsed and dried. Between appointments, Metapaste or Bio-C TEMP will be placed as intracanal medicament for 7-10 days. At the second appointment medicaments removed, final irrigation performed and root canals obturated and restored. Pain scores recorded at 6h,12h,1d,2d,3d,4d,5d,6d,7d ; follow-ups at 6, 12 and 24 months.
Read the detailed description
Within the scope of the project, two-visit root canal treatment will be performed on previously untreated, asymptomatic, single-rooted, single-canaled maxillary anterior teeth that have periapical lesions smaller than 5 mm on radiographs, no fractures or cracks, no internal or external resorption, no canal calcification, and no antibiotic use within the last week.
At the start of treatment, an initialradiograph will be taken of the tooth using a parallel film holder and archived. After rubber dam isolation, an access cavity will be prepared (all previous restorations will be removed if present). Working length will be determined by an apex locator. Root canal preparation will be performed using the step-back technique, with apical enlargement to at least size #40. Continuous irrigation with 2.5% NaOCl will be performed between each file. After instrumentation, the root canals will be rinsed with distilled water and dried with paper points.
Between appointments, to achieve additional disinfection of the root canals, Metapaste containing Ca(OH)₂ intracanal medicament (Meta Biomed Co., Ltd., Chungcheongbuk-do, Korea) and the bioceramic-based intracanal medicament Bio-C TEMP (Angelus, Paraná, Brazil) will be placed in the root canals according to the manufacturers' instructions. The intracanal distribution of the medicaments will be checked visually and radiographically, and the medicaments will be left in place for 7-10 days. Patients will be instructed on how to record their pain scores on the NRS scale and will be provided with contact information in case of any swelling or pain.
At the second appointment, after removal of the medicaments, a periapical radiograph will be taken for gutta-percha trial and verified according to the working length. In the final irrigation procedure, 5 mL of 17% ethylenediaminetetraacetic acid (EDTA), 5 mL of 2.5% NaOCl, distilled water and 2% chlorhexidine will be used respectively. After drying the root canals with paper points, they will be obturated with gutta-percha and a resin-based sealer using the cold lateral compaction technique, and the access cavities will be restored with composite resin. A final radiograph will be taken using the parallel technique with a parallel film holder.
Patients will again be given the NRS form and asked to return the completed forms after 7 days. Clinical follow-ups will be performed at the 6th, 12th, and 24th months, and follow-up radiographs will be taken using a parallel film holder. Changes in the size of the periapical lesions compared to baseline will be evaluated.
- Being tested
- Bio-C Temp Intracanal Medication, Metapaste Intracanal Medication
- Keywords
- root canal treatment, chronic apical periodontitis, post operative pain, intracanal medicament
- Medical subject headings
- Pain, Postoperative, Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bio-C Temp Intracanal MedicationOther
Bio-C Temp (Angelus, Paraná, Brazil) is a ready-to-use calcium silicate-based material designed for use between appointments. Bio-C Temp is indicated for use as a substitute for calcium hydroxide, as a medicament for necrotic teeth or root canal resurfacing treatments, and for the treatment of internal and external root resorption and immature teeth.
Metapaste Intracanal MedicationOther
Metapaste (Meta Bıomed Co.,Ltd., Chungcheongbuk-do,Korea) is a ready-to-use calcium hydroxide-based material designed for use between appointments.Metapaste is indicated for use as a medicament for necrotic teeth or root canal resurfacing treatments, and for the treatment of internal and external root resorption and immature teeth.
| Study group | Role | What they receive |
|---|---|---|
| Two visit root canal treatment with Bio-C TEMP | Active comparator | Two-visit root canal treatment will be performed on the study teeth. Bio-C TEMP (Angelus, Paraná, Brazil), a bioceramic-based intracanal medicament, will be placed in the root canals between appointments according to the manufacturer's instructions. Receives: Other: Bio-C Temp Intracanal Medication |
| Two visit root canal treatment with Meta Paste | Active comparator | Two-visit root canal treatment will be performed on the study teeth. Meta Paste(Meta Biomed Co., Ltd., Chungcheongbuk-do, Korea) a calcium hydroxide based intracanal medicament, will be placed in theroot canals between appointments according to the manufacturer's instructions. Receives: Other: Metapaste Intracanal Medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Pain
Following two -visit root canal treatment performed with different intracanal medicament types , the Numerical Rating Scale (NRS) was used to assess both inter-appointment and after obturation. Compare the patients' pain levels, and the patients were instructed to record their pain at 6, 12, 24, 48, and 72 hours, as well as on the 7th day. Patients were informed that a score of 0 represented no pain, while a score of 10 represented the maximum pain, with higher scores indicating greater pain intensity
Measured: Immediately after treatment, between appointments and after obturation for up to 7 days postoperatively
Secondary outcomes (1)
Changes in the size and the PAI score of the periapical lesion
The rate of radiographic healing of the periapical lesion. Follow-up visits were performed for all patients in order to evaluate radiographic status. Changes in apical bone density indicating radiographic healing was assessed using Periapical Index (PAI) as the scoring system.
Measured: At 6,12 and 24 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start1 Aug 2024
- Primary completion29 May 2025
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root Canal TreatmentStudies of the same condition, open and under way.
- More trials run by Ege 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Collaborators
- Health Institutes of Turkey
- Responsible party
- Principal investigator, Seniha Miçooğulları Kurt, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210177
- Sponsor's protocol ID
- EUDF-ETK-24-6/7
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2025
- Last updated
- 7 Oct 2025
- Results posted
- 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 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Root Canal Treatments Performed Using Two Different Intracanal Medicaments
- ClinicalTrials.gov ID
- NCT07210177
- Acronym / sponsor ID
- EUDF-ETK-24-6/7
- Keywords
- root canal treatment, chronic apical periodontitis, post operative pain, intracanal medicament
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Collaborators
- Health Institutes of Turkey
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 29 May 2025 (actual)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 7 Oct 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.
Previously untreated, asymptomatic, single-rooted maxillary anterior teeth with periapical lesions <5 mm, no fractures, resorption, calcification, or recent antibiotic use will performed two-visit root canal treatment. Initial radiographs will be taken. After rubber-dam isolation, working length will be determined; canals prepared step-back to size #40 with sodium hypochlorite (NaOCl) irrigation, rinsed and dried. Between appointments, Metapaste or Bio-C TEMP will be placed as intracanal medicament for 7-10 days. At the second appointment medicaments removed, final irrigation performed and root canals obturated and restored. Pain scores recorded at 6h,12h,1d,2d,3d,4d,5d,6d,7d ; follow-ups at 6, 12 and 24 months.
Detailed description
Within the scope of the project, two-visit root canal treatment will be performed on previously untreated, asymptomatic, single-rooted, single-canaled maxillary anterior teeth that have periapical lesions smaller than 5 mm on radiographs, no fractures or cracks, no internal or external resorption, no canal calcification, and no antibiotic use within the last week.
At the start of treatment, an initialradiograph will be taken of the tooth using a parallel film holder and archived. After rubber dam isolation, an access cavity will be prepared (all previous restorations will be removed if present). Working length will be determined by an apex locator. Root canal preparation will be performed using the step-back technique, with apical enlargement to at least size #40. Continuous irrigation with 2.5% NaOCl will be performed between each file. After instrumentation, the root canals will be rinsed with distilled water and dried with paper points.
Between appointments, to achieve additional disinfection of the root canals, Metapaste containing Ca(OH)₂ intracanal medicament (Meta Biomed Co., Ltd., Chungcheongbuk-do, Korea) and the bioceramic-based intracanal medicament Bio-C TEMP (Angelus, Paraná, Brazil) will be placed in the root canals according to the manufacturers' instructions. The intracanal distribution of the medicaments will be checked visually and radiographically, and the medicaments will be left in place for 7-10 days. Patients will be instructed on how to record their pain scores on the NRS scale and will be provided with contact information in case of any swelling or pain.
At the second appointment, after removal of the medicaments, a periapical radiograph will be taken for gutta-percha trial and verified according to the working length. In the final irrigation procedure, 5 mL of 17% ethylenediaminetetraacetic acid (EDTA), 5 mL of 2.5% NaOCl, distilled water and 2% chlorhexidine will be used respectively. After drying the root canals with paper points, they will be obturated with gutta-percha and a resin-based sealer using the cold lateral compaction technique, and the access cavities will be restored with composite resin. A final radiograph will be taken using the parallel technique with a parallel film holder.
Patients will again be given the NRS form and asked to return the completed forms after 7 days. Clinical follow-ups will be performed at the 6th, 12th, and 24th months, and follow-up radiographs will be taken using a parallel film holder. Changes in the size of the periapical lesions compared to baseline will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Two visit root canal treatment with Bio-C TEMP | Active comparator | Other: Bio-C Temp Intracanal MedicationTwo-visit root canal treatment will be performed on the study teeth. Bio-C TEMP (Angelus, Paraná, Brazil), a bioceramic-based intracanal medicament, will be placed in the root canals between appointments according to the manufacturer's instructions. |
| Two visit root canal treatment with Meta Paste | Active comparator | Other: Metapaste Intracanal MedicationTwo-visit root canal treatment will be performed on the study teeth. Meta Paste(Meta Biomed Co., Ltd., Chungcheongbuk-do, Korea) a calcium hydroxide based intracanal medicament, will be placed in theroot canals between appointments according to the manufacturer's instructions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- with a non-contributory medical history, mature maxillary incisor teeth with periapical lesions, diagnosed as asymptomatic apical periodontitis
Key exclusion criteria (1 listed)
- clinical symptoms, drainage, more than 5 mm loss of periodontal attachment, Teeth with periapical lesions larger than 5 mm previous endodontic treatment, non-restorable tooth patient with taken antibiotic or analgesics
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 |
|---|---|---|
| Bio-C Temp Intracanal MedicationBio-C Temp (Angelus, Paraná, Brazil) is a ready-to-use calcium silicate-based material designed for use between appointments. Bio-C Temp is indicated for use as a substitute for calcium hydroxide, as a medicament for necrotic teeth or root canal resurfacing treatments, and for the treatment of internal and external root resorption and immature teeth. | Other | Two visit root canal treatment with Bio-C TEMP |
| Metapaste Intracanal MedicationMetapaste (Meta Bıomed Co.,Ltd., Chungcheongbuk-do,Korea) is a ready-to-use calcium hydroxide-based material designed for use between appointments.Metapaste is indicated for use as a medicament for necrotic teeth or root canal resurfacing treatments, and for the treatment of internal and external root resorption and immature teeth. | Other | Two visit root canal treatment with Meta Paste |
Primary outcome
Post-operative Pain
Time frame: Immediately after treatment, between appointments and after obturation for up to 7 days postoperatively
Following two -visit root canal treatment performed with different intracanal medicament types , the Numerical Rating Scale (NRS) was used to assess both inter-appointment and after obturation. Compare the patients' pain levels, and the patients were instructed to record their pain at 6, 12, 24, 48, and 72 hours, as well as on the 7th day. Patients were informed that a score of 0 represented no pain, while a score of 10 represented the maximum pain, with higher scores indicating greater pain intensity
1 secondary outcome
Changes in the size and the PAI score of the periapical lesion
Time frame: At 6,12 and 24 months after treatment.
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 7 Oct 2025.
- 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 Bio-C Temp Intracanal Medication and Metapaste Intracanal Medication in people with Root Canal Treatment and Intracanal Medicament, run by Ege 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 7 Oct 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?
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?
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?
Post-operative Pain (time frame: Immediately after treatment, between appointments and after obturation for up to 7 days postoperatively). 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 7 Oct 2025.