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

NCT07396688 | Recruiting

• 1 other identifier: 25-AKD-303
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Keywords

Visual Analog Scale; Postoperative Pain; Bioceramic Intracanal Medicament; Endodontic Retreatment; Calcium Hydroxide

Outcome Measures

Primary Outcomes (1)

• 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).

  12 hours, 24 hours, 3 days, 5 days, 7 days

Secondary Outcomes (1)

• Analgesic Consumption

  Up to 24 hours post-treatment; up to 3 days post-treatment; up to 5 days post-treatment; up to 7 days post-treatment.

Study Arms (2)

Bio-C Temp Group

EXPERIMENTAL

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

Calcium Hydroxide Group

ACTIVE COMPARATOR

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

Interventions

bioceramic based intracanal medication DRUG

Bioceramic intracanal medicament (Bio-C Temp®, Angelus): A bioceramic-based intracanal medicament used between treatment sessions.

Bio-C Temp Group

Calcium Hydroxide Intracanal medication DRUG

Calcium Hydroxide: A conventional intracanal medicament used between treatment sessions.

Calcium Hydroxide Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara University: lead

Study Sites (2)

Ankara University Faculty of Dentistry

Ankara, Ankara, 06100, Turkey (Türkiye)

RECRUITING

Ankara University Faculty of Dentistry

Ankara, Ankara, 06500, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• Wagh KS, Warhadpande MM, Dakshindas DM. Prevalence of endodontic flare-up following intracanal medicament placement in permanent teeth undergoing endodontic treatment - A systematic review. J Conserv Dent. 2022 Jan-Feb;25(1):3-8. doi: 10.4103/jcd.jcd_332_21. Epub 2022 May 2.

  PMID: 35722066 BACKGROUND

• Karaoglan F, Kiziltas Gul A, Caliskan MK. Postoperative Pain Following Single-Visit Versus Two-Visit Endodontic Retreatment - A Comparison of Inter-Appointment and Post-Obturation Periods: Randomised Clinical Trial. Aust Endod J. 2025 Dec;51(3):706-714. doi: 10.1111/aej.70004. Epub 2025 Aug 13.

  PMID: 40801476 BACKGROUND

• Angin AE, Ozkan HD, Saral IP, Aydin B. The incidence and intensity of postoperative pain and Flare-up following the use of three different intracanal medicaments in teeth with posttreatment apical periodontitis: a randomized clinical trial. Clin Oral Investig. 2024 Jun 8;28(7):362. doi: 10.1007/s00784-024-05760-w.

  PMID: 38849655 BACKGROUND

• Omaia M, Negm M, Nashaat Y, Nabil N, Othman A. The effect of triple antibiotic paste as an intracanal medicament with an anti-inflammatory agent on post-operative pain of asymptomatic uniradicular necrotic teeth: a double blind randomized clinical trial. F1000Res. 2025 Dec 16;8:1687. doi: 10.12688/f1000research.19699.3. eCollection 2019.

  PMID: 41552268 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors are blinded to the intracanal medicament used. The intracanal medicaments are applied by a separate investigator who is aware of the treatment assignment but is not involved in outcome assessment or data analysis. Outcome assessments are performed using coded patient records to maintain blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants are randomly assigned to one of two parallel groups according to the intracanal medicament used during the interappointment period. One group receives calcium hydroxide, while the other group receives Bio-C Temp. Each participant is assigned to only one treatment group, and outcomes are evaluated and compared between the two groups over the same follow-up period.

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 9, 2026
• Study Start: March 25, 2026
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)