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

March 25, 2026 updated by: Assist.Prof.Emine ODABAŞI TEZER, Ankara University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Ankara
      • Ankara, Ankara, Turkey (Türkiye), 06100
        • Recruiting
        • Ankara University Faculty of Dentistry
        • Contact:
      • Ankara, Ankara, Turkey (Türkiye), 06500
        • Recruiting
        • Ankara University Faculty of Dentistry
        • Contact:
        • Contact:
        • Principal Investigator:
          • Emine ODABAŞI TEZER, DDS
        • Sub-Investigator:
          • İrem Dilara KILIÇ, DDS
        • Sub-Investigator:
          • Ahmet BÖLÜK, DDS
        • Sub-Investigator:
          • Beyza ÖZTÜRK, DDS
        • Principal Investigator:
          • Meltem ÖZTAN, DDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • • 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.

Exclusion Criteria:

  • • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bio-C Temp Group
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.
Drug: bioceramic based intracanal medication

Bioceramic intracanal medicament (Bio-C Temp®, Angelus):

A bioceramic-based intracanal medicament used between treatment sessions.
Active Comparator: Calcium Hydroxide Group
Patients receive calcium hydroxide as an intracanal medicament placed in the root canal system during the interappointment period of multi-visit endodontic retreatment.
Drug: Calcium Hydroxide Intracanal medication

Calcium Hydroxide:

A conventional intracanal medicament used between treatment sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 hours, 24 hours, 3 days, 5 days, 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
  • 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).
Up to 24 hours post-treatment; up to 3 days post-treatment; up to 5 days post-treatment; up to 7 days post-treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 25, 2026

Primary Completion (Estimated)

April 15, 2026

Study Completion (Estimated)

April 15, 2026

Study Registration Dates

First Submitted

January 27, 2026

First Submitted That Met QC Criteria

February 4, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-AKD-303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to ethical and confidentiality considerations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Pain

Clinical Trials on bioceramic based intracanal medication

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe