About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• 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.
Disqualifiers
• 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.
Trial design
Parallel
Treatments tested in this trial
bioceramic based intracanal medication
DrugBioceramic intracanal medicament (Bio-C Temp®, Angelus): A bioceramic-based intracanal medicament used between treatment sessions.
Calcium Hydroxide Intracanal medication
DrugCalcium Hydroxide: A conventional intracanal medicament used between treatment sessions.
Treatment groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
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).
Sponsors and contacts
Click on the lead sponsor to view all of their trials.