Postoperative PainNCT07396688
Comparative Evaluation of the Effects of Calcium Hydroxide and BIO-C Temp Medicaments on Postoperative Pain in Patients Undergoing Endodontic Treatment: a Clinical Study
A study testing bioceramic based intracanal medication and Calcium Hydroxide Intracanal medication in people with Postoperative Pain and Medicaments Substances in Therapeutic Use, run by Ankara University at 2 sites in Turkey (Türkiye).
Trial summary
This clinical study is designed to evaluate postoperative pain experienced by patients undergoing multi-visit endodontic retreatment and to investigate whether the choice of intracanal medicament influences pain levels between treatment sessions. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain, Medicaments Substances in Therapeutic Use, Calcium Hydroxide
- What is being tested?
- bioceramic based intracanal medication and Calcium Hydroxide Intracanal medication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 25 Sep 2025to 15 Feb 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
- • Patients with single-rooted teeth requiring endodontic retreatment.
- Individuals in good general health, classified as ASA Physical Status I.
- Teeth presenting normal anatomical structure and root morphology.
Who cannot join
- • Patients who have used antibiotics or analgesic medications within the last month.
- Pregnant individuals and patients with systemic diseases (such as chronic illnesses, diabetes mellitus, hypertension).
- Teeth with root fractures or perforations.
- Teeth with complex root canal anatomy, multirooted teeth, or severely curved roots.
- Patients presenting with high baseline pain levels, particularly those with a history of treatment-resistant pain.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ankara University Faculty of Dentistry
Ankara, Ankara, 06100
Ankara University Faculty of Dentistry
Ankara, Ankara, 06500
About this study
This clinical study is designed to evaluate postoperative pain experienced by patients undergoing multi-visit endodontic retreatment and to investigate whether the choice of intracanal medicament influences pain levels between treatment sessions. Postoperative pain is a common concern following root canal procedures and may negatively affect patient comfort, treatment satisfaction, and overall perception of dental care.
Calcium hydroxide has long been used as a conventional intracanal medicament in endodontic therapy due to its antimicrobial properties. In recent years, bioceramic-based materials such as Bio-C Temp have been introduced as alternative intracanal medicaments, with proposed advantages related to biocompatibility and interaction with dental tissues. However, limited clinical evidence is available regarding their effect on postoperative pain when compared with conventional materials.
Read more
In this study, patients requiring multi-visit endodontic retreatment will receive either calcium hydroxide or Bio-C Temp as an intracanal medicament between treatment sessions. Pain intensity will be evaluated at specific time points following treatment using standardized pain assessment scales. In addition to pain intensity, the use of analgesic medication will also be recorded.
The primary objective of this study is to compare interappointment postoperative pain levels associated with calcium hydroxide and Bio-C Temp. Secondary objectives include evaluating analgesic consumption. By comparing a conventional intracanal medicament with a newer bioceramic-based alternative, this study aims to contribute to a better understanding of how intracanal medicament selection may influence postoperative pain and patient experience during endodontic retreatment.
The findings of this study may help clinicians make more informed decisions regarding intracanal medicament selection and improve pain management strategies in endodontic practice.
Read the detailed description
This clinical study is a comparative investigation designed to evaluate interappointment postoperative pain in patients undergoing multi-visit endodontic retreatment. Postoperative pain is a frequent concern in endodontic practice and may affect patient comfort, treatment compliance, and overall satisfaction. The study focuses on whether the choice of intracanal medicament used between treatment sessions influences postoperative pain levels and patient-reported outcomes.
Study Design
The study is conducted as a clinical, comparative study involving patients who require multi-visit endodontic retreatment of single-rooted teeth. Following the initial treatment session, eligible patients are assigned to receive one of two intracanal medicaments during the interappointment period.
Participants
Patients included in the study are systemically healthy individuals classified as ASA Physical Status I, presenting with single-rooted teeth requiring endodontic retreatment and exhibiting normal root anatomy. Patients with conditions or factors that could influence pain perception or treatment outcomes are excluded. All participants provide informed consent prior to enrollment.
Interventions
After completion of the initial endodontic retreatment procedures, intracanal medicaments are placed between treatment sessions. Patients receive either calcium hydroxide, a conventional intracanal medicament, or Bio-C Temp, a newer bioceramic-based intracanal medicament proposed as an alternative to traditional materials. The assigned medicament remains in the root canal system throughout the interappointment period until the subsequent treatment session.
Follow-up and Pain Assessment
Postoperative pain is assessed during the interappointment period using standardized pain assessment tools. Patients are asked to record their pain intensity at predefined time points following the initial treatment session, specifically at 12 hours, 24 hours, 3 days, 5 days, and 7 days. Pain intensity is evaluated using validated pain rating scales, such as the Visual Analog Scale or Numerical Rating Scale.
In addition to pain intensity, patients are monitored for analgesic consumption during the interappointment period. Information regarding the use of pain-relieving medications is recorded at the same follow-up time points.
Outcome Measures
The primary outcome measure of the study is interappointment postoperative pain intensity associated with each intracanal medicament. According to the clinical protocol, a standard-dose analgesic will be prescribed to all participants for postoperative pain control (for example, ibuprofen 400-600 mg to be taken as needed, no more often than every 4-6 hours). Analgesic use will be entirely determined by pain levels, and the number of tablets taken will be documented as a secondary outcome measure.
Study Objective
The primary objective of this study is to compare the effects of calcium hydroxide and Bio-C Temp on interappointment postoperative pain in multi-visit endodontic retreatment. By comparing a conventional intracanal medicament with a newer bioceramic-based alternative, the study aims to provide clinically relevant information that may assist clinicians in selecting intracanal medicaments and improving pain management strategies in endodontic practice.
- Conditions
- Postoperative Pain, Medicaments Substances in Therapeutic Use, Calcium Hydroxide, Root Canal Retreatment
- Being tested
- bioceramic based intracanal medication, Calcium Hydroxide Intracanal medication
- Keywords
- Visual Analog Scale, Postoperative Pain, Bioceramic Intracanal Medicament, Endodontic Retreatment, Calcium Hydroxide
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bioceramic based intracanal medicationDrug
Bioceramic intracanal medicament (Bio-C Temp®, Angelus):
A bioceramic-based intracanal medicament used between treatment sessions.
Calcium Hydroxide Intracanal medicationDrug
Calcium Hydroxide:
A conventional intracanal medicament used between treatment sessions.
| Study group | Role | What they receive |
|---|---|---|
| Bio-C Temp Group | Experimental | Patients receive Bio-C Temp, a bioceramic-based intracanal medicament, placed in the root canal system during the interappointment period of multi-visit endodontic retreatment. Receives: Drug: bioceramic based intracanal medication |
| Calcium Hydroxide Group | Active comparator | Patients receive calcium hydroxide as an intracanal medicament placed in the root canal system during the interappointment period of multi-visit endodontic retreatment. Receives: Drug: Calcium Hydroxide Intracanal medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interappointment Pain Intensity
- What is measured: Postoperative pain intensity will be measured using a patient-reported Visual Analog Scale (VAS).
- Instrument and range: The VAS is a 10 cm line anchored at 0 cm ("no pain") and 10 cm ("worst possible pain"); participants mark their pain level on this line .
- Unit and interpretation: Scores range from 0 to 10; higher scores indicate a worse outcome (more pain). The unit of measure is VAS score (0-10).
Measured: 12 hours, 24 hours, 3 days, 5 days, 7 days
Secondary outcomes (1)
Analgesic Consumption
- What is measured: The number of analgesic tablets used by participants for postoperative pain control will be recorded.
- How measured: At each specified time frame, participants will report the total number of tablets taken since the previous reporting point; values may range from 0 (no analgesics taken) to the maximum number permitted for that interval.
- Unit and interpretation: The unit of measurement is the number of tablets. Fewer tablets indicate better pain control (less pain).
Measured: Up to 24 hours post-treatment; up to 3 days post-treatment; up to 5 days post-treatment; up to 7 days post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start25 Sep 2025
- Primary completion12 Feb 2026
- Study completion15 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Ankara 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 to one of two parallel groups according to the intracanal medicament used during the interappointment period. One group receives calcium hydroxide, while the other group receives Bio-C Temp. Each participant is assigned to only one treatment group, and outcomes are evaluated and compared between the two groups over the same follow-up period.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assist.Prof.Emine ODABAŞI TEZER, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396688
- Sponsor's protocol ID
- 25-AKD-303
- Status last verified
- Oct 2026
- First submitted
- 27 Jan 2026
- Last updated
- 8 Oct 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 due to ethical and confidentiality considerations.
Publications
Wagh KS, Warhadpande MM, Dakshindas DM. Prevalence of endodontic flare-up following intracanal medicament placement in permanent teeth undergoing endodontic treatment - A systematic review. J Conserv Dent. 2022 Jan-Feb;25(1):3-8. doi: 10.4103/jcd.jcd_332_21. Epub 2022 May 2.
PubMed 35722066Karaoglan F, Kiziltas Gul A, Caliskan MK. Postoperative Pain Following Single-Visit Versus Two-Visit Endodontic Retreatment - A Comparison of Inter-Appointment and Post-Obturation Periods: Randomised Clinical Trial. Aust Endod J. 2025 Dec;51(3):706-714. doi: 10.1111/aej.70004. Epub 2025 Aug 13.
PubMed 40801476Angin AE, Ozkan HD, Saral IP, Aydin B. The incidence and intensity of postoperative pain and Flare-up following the use of three different intracanal medicaments in teeth with posttreatment apical periodontitis: a randomized clinical trial. Clin Oral Investig. 2024 Jun 8;28(7):362. doi: 10.1007/s00784-024-05760-w.
PubMed 38849655Omaia M, Negm M, Nashaat Y, Nabil N, Othman A. The effect of triple antibiotic paste as an intracanal medicament with an anti-inflammatory agent on post-operative pain of asymptomatic uniradicular necrotic teeth: a double blind randomized clinical trial. F1000Res. 2025 Dec 16;8:1687. doi: 10.12688/f1000research.19699.3. eCollection 2019.
PubMed 41552268
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of the Effects of Calcium Hydroxide and BIO-C Temp Medicaments on Postoperative Pain in Patients Undergoing Endodontic Treatment: a Clinical Study
- ClinicalTrials.gov ID
- NCT07396688
- Acronym / sponsor ID
- 25-AKD-303
- Conditions
- Postoperative Pain, Medicaments Substances in Therapeutic Use, Calcium Hydroxide, Root Canal Retreatment
- Keywords
- Visual Analog Scale, Postoperative Pain, Bioceramic Intracanal Medicament, Endodontic Retreatment, Calcium Hydroxide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- 12 Feb 2026 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 9 Feb 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 clinical study is designed to evaluate postoperative pain experienced by patients undergoing multi-visit endodontic retreatment and to investigate whether the choice of intracanal medicament influences pain levels between treatment sessions. Postoperative pain is a common concern following root canal procedures and may negatively affect patient comfort, treatment satisfaction, and overall perception of dental care.
Calcium hydroxide has long been used as a conventional intracanal medicament in endodontic therapy due to its antimicrobial properties. In recent years, bioceramic-based materials such as Bio-C Temp have been introduced as alternative intracanal medicaments, with proposed advantages related to biocompatibility and interaction with dental tissues. However, limited clinical evidence is available regarding their effect on postoperative pain when compared with conventional materials.
In this study, patients requiring multi-visit endodontic retreatment will receive either calcium hydroxide or Bio-C Temp as an intracanal medicament between treatment sessions. Pain intensity will be evaluated at specific time points following treatment using standardized pain assessment scales. In addition to pain intensity, the use of analgesic medication will also be recorded.
The primary objective of this study is to compare interappointment postoperative pain levels associated with calcium hydroxide and Bio-C Temp. Secondary objectives include evaluating analgesic consumption. By comparing a conventional intracanal medicament with a newer bioceramic-based alternative, this study aims to contribute to a better understanding of how intracanal medicament selection may influence postoperative pain and patient experience during endodontic retreatment.
The findings of this study may help clinicians make more informed decisions regarding intracanal medicament selection and improve pain management strategies in endodontic practice.
Detailed description
This clinical study is a comparative investigation designed to evaluate interappointment postoperative pain in patients undergoing multi-visit endodontic retreatment. Postoperative pain is a frequent concern in endodontic practice and may affect patient comfort, treatment compliance, and overall satisfaction. The study focuses on whether the choice of intracanal medicament used between treatment sessions influences postoperative pain levels and patient-reported outcomes.
Study Design
The study is conducted as a clinical, comparative study involving patients who require multi-visit endodontic retreatment of single-rooted teeth. Following the initial treatment session, eligible patients are assigned to receive one of two intracanal medicaments during the interappointment period.
Participants
Patients included in the study are systemically healthy individuals classified as ASA Physical Status I, presenting with single-rooted teeth requiring endodontic retreatment and exhibiting normal root anatomy. Patients with conditions or factors that could influence pain perception or treatment outcomes are excluded. All participants provide informed consent prior to enrollment.
Interventions
After completion of the initial endodontic retreatment procedures, intracanal medicaments are placed between treatment sessions. Patients receive either calcium hydroxide, a conventional intracanal medicament, or Bio-C Temp, a newer bioceramic-based intracanal medicament proposed as an alternative to traditional materials. The assigned medicament remains in the root canal system throughout the interappointment period until the subsequent treatment session.
Follow-up and Pain Assessment
Postoperative pain is assessed during the interappointment period using standardized pain assessment tools. Patients are asked to record their pain intensity at predefined time points following the initial treatment session, specifically at 12 hours, 24 hours, 3 days, 5 days, and 7 days. Pain intensity is evaluated using validated pain rating scales, such as the Visual Analog Scale or Numerical Rating Scale.
In addition to pain intensity, patients are monitored for analgesic consumption during the interappointment period. Information regarding the use of pain-relieving medications is recorded at the same follow-up time points.
Outcome Measures
The primary outcome measure of the study is interappointment postoperative pain intensity associated with each intracanal medicament. According to the clinical protocol, a standard-dose analgesic will be prescribed to all participants for postoperative pain control (for example, ibuprofen 400-600 mg to be taken as needed, no more often than every 4-6 hours). Analgesic use will be entirely determined by pain levels, and the number of tablets taken will be documented as a secondary outcome measure.
Study Objective
The primary objective of this study is to compare the effects of calcium hydroxide and Bio-C Temp on interappointment postoperative pain in multi-visit endodontic retreatment. By comparing a conventional intracanal medicament with a newer bioceramic-based alternative, the study aims to provide clinically relevant information that may assist clinicians in selecting intracanal medicaments and improving pain management strategies in endodontic practice.
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 to one of two parallel groups according to the intracanal medicament used during the interappointment period. One group receives calcium hydroxide, while the other group receives Bio-C Temp. Each participant is assigned to only one treatment group, and outcomes are evaluated and compared between the two groups over the same follow-up period.
| Arm | Type | Receives |
|---|---|---|
| Bio-C Temp Group | Experimental | Drug: bioceramic based intracanal medicationPatients receive Bio-C Temp, a bioceramic-based intracanal medicament, placed in the root canal system during the interappointment period of multi-visit endodontic retreatment. |
| Calcium Hydroxide Group | Active comparator | Drug: Calcium Hydroxide Intracanal medicationPatients receive calcium hydroxide as an intracanal medicament placed in the root canal system during the interappointment period of multi-visit endodontic retreatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Patients with single-rooted teeth requiring endodontic retreatment.
Key exclusion criteria (5 listed)
- • Patients who have used antibiotics or analgesic medications within the last month.
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 |
|---|---|---|
| bioceramic based intracanal medicationBioceramic intracanal medicament (Bio-C Temp®, Angelus): A bioceramic-based intracanal medicament used between treatment sessions. | Drug | Bio-C Temp Group |
| Calcium Hydroxide Intracanal medicationCalcium Hydroxide: A conventional intracanal medicament used between treatment sessions. | Drug | Calcium Hydroxide Group |
Primary outcome
Interappointment Pain Intensity
Time frame: 12 hours, 24 hours, 3 days, 5 days, 7 days
* What is measured: Postoperative pain intensity will be measured using a patient-reported Visual Analog Scale (VAS). * Instrument and range: The VAS is a 10 cm line anchored at 0 cm ("no pain") and 10 cm ("worst possible pain"); participants mark their pain level on this line . * Unit and interpretation: Scores range from 0 to 10; higher scores indicate a worse outcome (more pain). The unit of measure is VAS score (0-10).
1 secondary outcome
Analgesic Consumption
Time frame: Up to 24 hours post-treatment; up to 3 days post-treatment; up to 5 days post-treatment; up to 7 days post-treatment.
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 8 Oct 2026.
- Background: PubMed 35722066Wagh KS, Warhadpande MM, Dakshindas DM. Prevalence of endodontic flare-up following intracanal medicament placement in permanent teeth undergoing endodontic treatment - A systematic review. J Conserv Dent. 2022 Jan-Feb;25(1):3-8. doi: 10.4103/jcd.jcd_332_21. Epub 2022 May 2.
- Background: PubMed 40801476Karaoglan F, Kiziltas Gul A, Caliskan MK. Postoperative Pain Following Single-Visit Versus Two-Visit Endodontic Retreatment - A Comparison of Inter-Appointment and Post-Obturation Periods: Randomised Clinical Trial. Aust Endod J. 2025 Dec;51(3):706-714. doi: 10.1111/aej.70004. Epub 2025 Aug 13.
- Background: PubMed 38849655Angin AE, Ozkan HD, Saral IP, Aydin B. The incidence and intensity of postoperative pain and Flare-up following the use of three different intracanal medicaments in teeth with posttreatment apical periodontitis: a randomized clinical trial. Clin Oral Investig. 2024 Jun 8;28(7):362. doi: 10.1007/s00784-024-05760-w.
- Background: PubMed 41552268Omaia M, Negm M, Nashaat Y, Nabil N, Othman A. The effect of triple antibiotic paste as an intracanal medicament with an anti-inflammatory agent on post-operative pain of asymptomatic uniradicular necrotic teeth: a double blind randomized clinical trial. F1000Res. 2025 Dec 16;8:1687. doi: 10.12688/f1000research.19699.3. eCollection 2019.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical and confidentiality considerations.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bioceramic based intracanal medication and Calcium Hydroxide Intracanal medication in people with Postoperative Pain and Medicaments Substances in Therapeutic Use, run by Ankara University at 2 sites 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 3 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 8 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 2 sites 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?
Interappointment Pain Intensity (time frame: 12 hours, 24 hours, 3 days, 5 days, 7 days). 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 NCT07396688, which also lists 4 linked publications.
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 8 Oct 2026.