NCT07396688

Comparative Evaluation of the Effects of Calcium Hydroxide and BIO-C Temp Medicaments on Postoperative Pain in Patients Undergoing Endodontic Treatment: a Clinical Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Ankara University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Postoperative Pain
• Medicaments Substances in Therapeutic Use
• Calcium Hydroxide
• Root Canal Retreatment

Interventions

Type	Name	Description
DRUG	bioceramic based intracanal medication	Bioceramic intracanal medicament (Bio-C Temp®, Angelus): A bioceramic-based intracanal medicament used between treatment sessions.
DRUG	Calcium Hydroxide Intracanal medication	Calcium Hydroxide: A conventional intracanal medicament used between treatment sessions.

Timeline

• Start date: 2026-03-25
• Primary completion: 2026-04-15
• Completion: 2026-04-15
• First posted: 2026-02-09
• Last updated: 2026-03-27

Locations

2 sites across 1 country: Turkey (Türkiye)