Apical PeriodontitisNCT07913022
Early Healing of Apical Periodontitis After Root Canal Treatment With Bioceramic and Calcium Hydroxide Medicaments: Evaluation Using PAI and ImageJ
A study testing Bioceramic Intracanal Medicament and Calcium Hydroxide Intracanal Medication in people with Apical Periodontitis and Root Canal Treatment, run by Hasanuddin University at 1 site in Indonesia.
Trial summary
This study aims to evaluate and compare early radiographic healing of apical periodontitis following root canal treatment using bioceramic and calcium hydroxide intracanal medicaments. Participants with apical periodontitis who meet the eligibility criteria will be assigned to one of two treatment groups. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Apical Periodontitis, Root Canal Treatment, Intracanal Medicaments
- What is being tested?
- Bioceramic Intracanal Medicament and Calcium Hydroxide Intracanal Medication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndonesia
- Study dates
- 12 Jun 2026to 12 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults who are physically and mentally healthy and aged 18 years or older.
- Cooperative patients who are willing to attend the three-month follow-up after root canal treatment.
- Permanent mature anterior maxillary teeth diagnosed with apical periodontitis, based on patient history, intraoral clinical examination, negative pulp vitality test, negative palpation test, percussion testing, and a Periapical Index (PAI) score of 3 or higher on radiographic examination.
- Teeth with hermetic root canal obturation.
Who cannot join
- Teeth with advanced mobility.
- Teeth with periodontal pockets greater than 4 mm.
- Teeth that have previously undergone root canal treatment.
- Teeth with root fractures or fractures occurring during root canal treatment.
- Teeth with internal or external resorption.
- Teeth with open apices.
Show all 10Show fewer
- Teeth with calcified or obliterated root canals.
- Female patients who are pregnant during the follow-up period.
- Patients with systemic conditions requiring antibiotic prophylaxis for routine dental treatment or with systemic diseases that preclude participation.
- Patients unwilling to attend the three-month follow-up after root canal treatment.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dental and Oral Hospital of Hasanuddin University
Makassar, South Sulawesi, 90154
About this study
Official title: Effectiveness of Bioceramic Root Canal Medicament on Early Healing of Apical Periodontitis After Root Canal Treatment: A Periapical Radiographic Evaluation Using the PAI Index and ImageJ
This study aims to evaluate and compare early radiographic healing of apical periodontitis following root canal treatment using bioceramic and calcium hydroxide intracanal medicaments.
Participants with apical periodontitis who meet the eligibility criteria will be assigned to one of two treatment groups. The first group will receive a bioceramic intracanal medicament (Bio-C Temp, Angelus), while the second group will receive calcium hydroxide (Ultracal, Ultradent). The assigned medicament will be placed inside the root canal for two weeks as part of the root canal treatment procedure.
Read more
Periapical dental radiographs will be obtained at baseline and at the three-month follow-up using the paralleling technique. Radiographic images will be evaluated to assess changes in periapical healing over time.
Periapical healing will be assessed using the Periapical Index (PAI) and quantitative image analysis with ImageJ software. The PAI will be used to evaluate the radiographic status of the periapical tissues. ImageJ will be used to measure the area and density of periapical lesions and their fractal dimension on periapical radiographs.
The findings from the baseline and three-month follow-up assessments will be compared to evaluate changes in periapical lesions and to compare early radiographic healing between the bioceramic and calcium hydroxide groups.
The study is expected to provide information on the effectiveness of bioceramic and calcium hydroxide intracanal medicaments in promoting early radiographic healing of apical periodontitis following root canal treatment.
Read the detailed description
Apical periodontitis is an inflammatory condition affecting the periapical tissues and is commonly associated with microbial infection of the root canal system. Root canal treatment aims to control infection and promote healing of the periapical tissues. However, the extent and rate of radiographic healing may vary depending on the initial periapical condition and the effectiveness of endodontic treatment.
Intracanal medicaments are used during root canal treatment to help control residual microorganisms between treatment appointments. Calcium hydroxide is widely used because of its high alkalinity and antimicrobial properties. Bioceramic-based intracanal medicaments represent an alternative material in endodontic treatment. Comparing these medicaments may provide information regarding their effectiveness in promoting early radiographic healing of apical periodontitis.
This randomized controlled clinical study will evaluate and compare early radiographic healing of apical periodontitis following root canal treatment using bioceramic and calcium hydroxide intracanal medicaments. The study will be conducted at the Dental and Oral Hospital of Hasanuddin University, Makassar, Indonesia. A total of 24 participants who meet the predefined eligibility criteria are planned for inclusion, with 12 participants in the bioceramic group and 12 participants in the calcium hydroxide group.
Eligible participants will undergo root canal treatment and receive the intracanal medicament assigned to their treatment group. The bioceramic group will receive Bio-C Temp (Angelus), while the calcium hydroxide group will receive Ultracal (Ultradent). The assigned medicament will be placed inside the root canal for two weeks as part of the treatment protocol.
Periapical dental radiographs will be obtained at baseline and at the three-month follow-up using the paralleling technique. The radiographic images will be assessed to evaluate changes in periapical lesions over the follow-up period. The three-month follow-up assessments are planned to be completed by December 2026.
Radiographic evaluation will include the Periapical Index (PAI) and quantitative image analysis using ImageJ software. The PAI will be used to assess the radiographic status of the periapical tissues. ImageJ will be used to measure periapical lesion area, lesion density, and fractal dimension on the periapical radiographs. These measurements will be compared between baseline and the three-month follow-up to characterize radiographic changes associated with early periapical healing.
The primary outcome will be the change in radiographic indicators of periapical healing from baseline to the three-month follow-up. Secondary outcomes will include changes in PAI scores, periapical lesion area, lesion density, and fractal dimension, as well as comparisons of these changes between the bioceramic and calcium hydroxide groups.
This study is expected to provide comparative clinical information regarding early radiographic healing following the use of bioceramic and calcium hydroxide intracanal medicaments. The findings may also contribute to the evaluation of PAI and quantitative ImageJ analysis as methods for monitoring radiographic changes in periapical lesions after root canal treatment.
- Being tested
- Bioceramic Intracanal Medicament, Calcium Hydroxide Intracanal Medication
- Keywords
- Apical periodontitis, Periapical Healing, Bioceramic Intracanal Medicament, Calcium Hydroxide, Periapical Index (PAI), ImageJ, Periapical Lesion Area, Lesion Density, Fractal Dimension
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioceramic Intracanal MedicamentDrug
Also called BioCtemp
Bio-C Temp (Angelus) will be placed inside the root canal for two weeks as part of root canal treatment. Periapical dental radiographs will be obtained at baseline and at the three-month follow-up using the paralleling technique. Periapical healing will be evaluated using the Periapical Index (PAI) and ImageJ analysis to measure lesion area, lesion density, and fractal dimension.
Calcium Hydroxide Intracanal MedicationDrug
Also called Ultracal XS
Ultracal XS (Ultradent) will be placed inside the root canal for two weeks as part of root canal treatment. Periapical dental radiographs will be obtained at baseline and at the three-month follow-up using the paralleling technique. Periapical healing will be evaluated using the Periapical Index (PAI) and ImageJ analysis to measure lesion area, lesion density, and fractal dimension.
| Study group | Role | What they receive |
|---|---|---|
| Bioceramic Intracanal Medicament | Experimental | Participants in this group will receive a bioceramic intracanal medicament (Bio-C Temp, Angelus) as part of root canal treatment. The medicament will be placed inside the root canal for two weeks. Periapical radiographs will be obtained at baseline and at the three-month follow-up using the paralleling technique to evaluate periapical healing. Receives: Drug: Bioceramic Intracanal Medicament |
| Calcium Hydroxide Intracanal Medicament | Active comparator | Participants in this group will receive a calcium hydroxide intracanal medicament (Ultracal, Ultradent) as part of root canal treatment. The medicament will be placed inside the root canal for two weeks. Periapical radiographs will be obtained at baseline and at the three-month follow-up using the paralleling technique to evaluate periapical healing. Receives: Drug: Calcium Hydroxide Intracanal Medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Periapical Index (PAI) Score From Baseline to 3-Month Follow-up
Changes in Periapical Index (PAI) scores will be assessed by comparing periapical dental radiographs obtained at baseline and at the three-month follow-up. Radiographs will be evaluated by a blinded outcomes assessor. Changes in PAI scores will be compared between the bioceramic and calcium hydroxide groups.
Measured: Baseline to 3 months after treatment
Change in Periapical Lesion Area From Baseline to 3-Month Follow-up
Changes in periapical lesion area will be measured using ImageJ software on periapical dental radiographs obtained at baseline and at the three-month follow-up. Radiographs will be obtained using the paralleling technique and evaluated by a blinded outcomes assessor. Changes in lesion area will be compared between the bioceramic and calcium hydroxide groups.
Measured: Baseline to 3 months after treatment
Change in Periapical Lesion Density From Baseline to 3-Month Follow-up
Changes in periapical lesion density will be assessed quantitatively using ImageJ software on periapical dental radiographs obtained at baseline and at the three-month follow-up. Radiographs will be evaluated by a blinded outcomes assessor, and changes will be compared between the bioceramic and calcium hydroxide groups.
Measured: Baseline to 3 months after treatment
Change in Periapical Lesion Fractal Dimension From Baseline to 3-Month Follow-up
Changes in the fractal dimension of periapical lesions will be measured using ImageJ-based image analysis on periapical dental radiographs obtained at baseline and at the three-month follow-up. Radiographs will be evaluated by a blinded outcomes assessor, and changes will be compared between the bioceramic and calcium hydroxide groups.
Measured: Baseline to 3 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 posted3 Nov 2026
- Study start12 Jun 2026
- Primary completion12 Dec 2026 (estimated)
- Study completion12 Dec 2026 (estimated)
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.
- 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 will be allocated to one of two parallel intervention groups: a bioceramic intracanal medicament group (Bio-C Temp) or a calcium hydroxide intracanal medicament group (Ultracal). Radiographic outcomes will be assessed at baseline and at the three-month follow-up and compared between the two groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shinta Lucia Takahindangen, Hasanuddin University
- Investigators
- Shinta Lucia Takahindangen, drg, Principal investigator, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913022
- Sponsor's protocol ID
- 064/FKGUH/PPDGS_Kons-007/2026
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 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 with other researchers. The data contain confidential clinical and radiographic information, and sharing is not planned under the current study protocol. Only aggregate results will be reported in publications.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Bioceramic Root Canal Medicament on Early Healing of Apical Periodontitis After Root Canal Treatment: A Periapical Radiographic Evaluation Using the PAI Index and ImageJ
- ClinicalTrials.gov ID
- NCT07913022
- Acronym / sponsor ID
- 064/FKGUH/PPDGS_Kons-007/2026
- Keywords
- Apical periodontitis, Periapical Healing, Bioceramic Intracanal Medicament, Calcium Hydroxide, Periapical Index (PAI), ImageJ, Periapical Lesion Area, Lesion Density
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 12 Jun 2026 (actual)
- Primary completion
- 12 Dec 2026 (estimated)
- Study completion
- 12 Dec 2026 (estimated)
- First posted
- 3 Nov 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 study aims to evaluate and compare early radiographic healing of apical periodontitis following root canal treatment using bioceramic and calcium hydroxide intracanal medicaments.
Participants with apical periodontitis who meet the eligibility criteria will be assigned to one of two treatment groups. The first group will receive a bioceramic intracanal medicament (Bio-C Temp, Angelus), while the second group will receive calcium hydroxide (Ultracal, Ultradent). The assigned medicament will be placed inside the root canal for two weeks as part of the root canal treatment procedure.
Periapical dental radiographs will be obtained at baseline and at the three-month follow-up using the paralleling technique. Radiographic images will be evaluated to assess changes in periapical healing over time.
Periapical healing will be assessed using the Periapical Index (PAI) and quantitative image analysis with ImageJ software. The PAI will be used to evaluate the radiographic status of the periapical tissues. ImageJ will be used to measure the area and density of periapical lesions and their fractal dimension on periapical radiographs.
The findings from the baseline and three-month follow-up assessments will be compared to evaluate changes in periapical lesions and to compare early radiographic healing between the bioceramic and calcium hydroxide groups.
The study is expected to provide information on the effectiveness of bioceramic and calcium hydroxide intracanal medicaments in promoting early radiographic healing of apical periodontitis following root canal treatment.
Detailed description
Apical periodontitis is an inflammatory condition affecting the periapical tissues and is commonly associated with microbial infection of the root canal system. Root canal treatment aims to control infection and promote healing of the periapical tissues. However, the extent and rate of radiographic healing may vary depending on the initial periapical condition and the effectiveness of endodontic treatment.
Intracanal medicaments are used during root canal treatment to help control residual microorganisms between treatment appointments. Calcium hydroxide is widely used because of its high alkalinity and antimicrobial properties. Bioceramic-based intracanal medicaments represent an alternative material in endodontic treatment. Comparing these medicaments may provide information regarding their effectiveness in promoting early radiographic healing of apical periodontitis.
This randomized controlled clinical study will evaluate and compare early radiographic healing of apical periodontitis following root canal treatment using bioceramic and calcium hydroxide intracanal medicaments. The study will be conducted at the Dental and Oral Hospital of Hasanuddin University, Makassar, Indonesia. A total of 24 participants who meet the predefined eligibility criteria are planned for inclusion, with 12 participants in the bioceramic group and 12 participants in the calcium hydroxide group.
Eligible participants will undergo root canal treatment and receive the intracanal medicament assigned to their treatment group. The bioceramic group will receive Bio-C Temp (Angelus), while the calcium hydroxide group will receive Ultracal (Ultradent). The assigned medicament will be placed inside the root canal for two weeks as part of the treatment protocol.
Periapical dental radiographs will be obtained at baseline and at the three-month follow-up using the paralleling technique. The radiographic images will be assessed to evaluate changes in periapical lesions over the follow-up period. The three-month follow-up assessments are planned to be completed by December 2026.
Radiographic evaluation will include the Periapical Index (PAI) and quantitative image analysis using ImageJ software. The PAI will be used to assess the radiographic status of the periapical tissues. ImageJ will be used to measure periapical lesion area, lesion density, and fractal dimension on the periapical radiographs. These measurements will be compared between baseline and the three-month follow-up to characterize radiographic changes associated with early periapical healing.
The primary outcome will be the change in radiographic indicators of periapical healing from baseline to the three-month follow-up. Secondary outcomes will include changes in PAI scores, periapical lesion area, lesion density, and fractal dimension, as well as comparisons of these changes between the bioceramic and calcium hydroxide groups.
This study is expected to provide comparative clinical information regarding early radiographic healing following the use of bioceramic and calcium hydroxide intracanal medicaments. The findings may also contribute to the evaluation of PAI and quantitative ImageJ analysis as methods for monitoring radiographic changes in periapical lesions after root canal treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be allocated to one of two parallel intervention groups: a bioceramic intracanal medicament group (Bio-C Temp) or a calcium hydroxide intracanal medicament group (Ultracal). Radiographic outcomes will be assessed at baseline and at the three-month follow-up and compared between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Bioceramic Intracanal Medicament | Experimental | Drug: Bioceramic Intracanal MedicamentParticipants in this group will receive a bioceramic intracanal medicament (Bio-C Temp, Angelus) as part of root canal treatment. The medicament will be placed inside the root canal for two weeks. Periapical radiographs will be obtained at baseline and at the three-month follow-up using the paralleling technique to evaluate periapical healing. |
| Calcium Hydroxide Intracanal Medicament | Active comparator | Drug: Calcium Hydroxide Intracanal MedicationParticipants in this group will receive a calcium hydroxide intracanal medicament (Ultracal, Ultradent) as part of root canal treatment. The medicament will be placed inside the root canal for two weeks. Periapical radiographs will be obtained at baseline and at the three-month follow-up using the paralleling technique to evaluate periapical healing. |
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 who are physically and mentally healthy and aged 18 years or older.
- Cooperative patients who are willing to attend the three-month follow-up after root canal treatment.
- Permanent mature anterior maxillary teeth diagnosed with apical periodontitis, based on patient history, intraoral clinical examination, negative pulp vitality test, negative palpation test, percussion testing, and a Periapical Index (PAI) score of 3 or higher on radiographic examination.
- Teeth with hermetic root canal obturation.
Key exclusion criteria (10 listed)
- Teeth with advanced mobility.
- Teeth with periodontal pockets greater than 4 mm.
- Teeth that have previously undergone root canal treatment.
- Teeth with root fractures or fractures occurring during root canal treatment.
- Teeth with internal or external resorption.
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 Intracanal MedicamentAlso: BioCtempBio-C Temp (Angelus) will be placed inside the root canal for two weeks as part of root canal treatment. Periapical dental radiographs will be obtained at baseline and at the three-month follow-up using the paralleling technique. Periapical healing will be evaluated using the Periapical Index (PAI) and ImageJ analysis to measure lesion area, lesion density, and fractal dimension. | Drug | Bioceramic Intracanal Medicament |
| Calcium Hydroxide Intracanal MedicationAlso: Ultracal XSUltracal XS (Ultradent) will be placed inside the root canal for two weeks as part of root canal treatment. Periapical dental radiographs will be obtained at baseline and at the three-month follow-up using the paralleling technique. Periapical healing will be evaluated using the Periapical Index (PAI) and ImageJ analysis to measure lesion area, lesion density, and fractal dimension. | Drug | Calcium Hydroxide Intracanal Medicament |
Primary outcome
Change in Periapical Index (PAI) Score From Baseline to 3-Month Follow-up
Time frame: Baseline to 3 months after treatment
Changes in Periapical Index (PAI) scores will be assessed by comparing periapical dental radiographs obtained at baseline and at the three-month follow-up. Radiographs will be evaluated by a blinded outcomes assessor. Changes in PAI scores will be compared between the bioceramic and calcium hydroxide groups.
Change in Periapical Lesion Area From Baseline to 3-Month Follow-up
Time frame: Baseline to 3 months after treatment
Changes in periapical lesion area will be measured using ImageJ software on periapical dental radiographs obtained at baseline and at the three-month follow-up. Radiographs will be obtained using the paralleling technique and evaluated by a blinded outcomes assessor. Changes in lesion area will be compared between the bioceramic and calcium hydroxide groups.
Change in Periapical Lesion Density From Baseline to 3-Month Follow-up
Time frame: Baseline to 3 months after treatment
Changes in periapical lesion density will be assessed quantitatively using ImageJ software on periapical dental radiographs obtained at baseline and at the three-month follow-up. Radiographs will be evaluated by a blinded outcomes assessor, and changes will be compared between the bioceramic and calcium hydroxide groups.
Change in Periapical Lesion Fractal Dimension From Baseline to 3-Month Follow-up
Time frame: Baseline to 3 months after treatment
Changes in the fractal dimension of periapical lesions will be measured using ImageJ-based image analysis on periapical dental radiographs obtained at baseline and at the three-month follow-up. Radiographs will be evaluated by a blinded outcomes assessor, and changes will be compared between the bioceramic and calcium hydroxide groups.
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 3 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers. The data contain confidential clinical and radiographic information, and sharing is not planned under the current study protocol. Only aggregate results will be reported in publications.
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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.
Shinta Lucia Takahindangen, drg principal investigator
Hasanuddin 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 Bioceramic Intracanal Medicament and Calcium Hydroxide Intracanal Medication in people with Apical Periodontitis and Root Canal Treatment, run by Hasanuddin University at 1 site in Indonesia.
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 10 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 3 Nov 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 Indonesia. 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?
Change in Periapical Index (PAI) Score From Baseline to 3-Month Follow-up (time frame: Baseline to 3 months after treatment). The study lists 4 primary outcomes in all. 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 3 Nov 2026.