An interventional study of Bioceramic Intracanal Medicament and Calcium Hydroxide Intracanal Medication in Apical Periodontitis, Root Canal Treatment and Intracanal Medicaments, sponsored by Hasanuddin University. Active, not recruiting at 1 site in Indonesia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Hasanuddin University · Not applicable, Interventional, and Treatment
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.
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.
280 studies on the registry are indexed under Periapical Periodontitis; 79 are open to participants now.
This study's planned enrollment of 24 is below the median of 60 across 245 interventional studies indexed under Periapical Periodontitis.
Browse Periapical Periodontitis studies →Hasanuddin University is the lead sponsor of 69 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
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.
Drug: Bioceramic Intracanal Medicament
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.
Drug: Calcium Hydroxide Intracanal Medication
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.
Also known as: BioCtemp
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.
Also known as: Ultracal XS
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 3 months after treatment
Plan to share: 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.
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Dec 2026, 6 months after the start.
Of 171 non-industry interventional studies with no phase under Periapical Periodontitis, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 19. This study's planned 6 months is below that.
Counting every sponsor, half of 172 studies reached it within 12 months; a quarter within 6 and three quarters within 19.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Hasanuddin University