Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID07396688

Comparative Evaluation of Calcium Hydroxide and BIO-C Temp Medicaments on Postoperative Pain in Patients Undergoing Endodontic Retreatment

Led by Ankara University · Updated on 2026-03-27

60

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating postoperative pain in patients undergoing multi-visit endodontic retreatment, focusing on whether the type of intracanal medicament used between visits affects pain levels. This clinical study compares a conventional calcium hydroxide medicament with a newer bioceramic-based material called Bio-C Temp, aiming to understand their impact on patient comfort and pain management during treatment. Participants receive either calcium hydroxide or Bio-C Temp placed inside the root canal system between treatment sessions. The assigned medicament remains in place during the interappointment period until the next treatment visit. The study follows a randomized and double-blind design to fairly compare these two intracanal medicaments. During the interappointment period, patients record their pain intensity at 12 hours, 24 hours, 3 days, 5 days, and 7 days after treatment using standardized pain scales. Researchers also track the use of pain relief medication at these same time points. The main measure is postoperative pain intensity, while analgesic consumption is evaluated as a secondary outcome. The study aims to provide insights that may help improve pain management in endodontic practice.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Adults aged 18 to 65 years
Not Eligible

You will not qualify if you...

  • 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, or 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, especially those with treatment-resistant pain history

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for eligibility assessment and informed consent

Treatment

Duration - Interappointment period lasting up to 7 days

Participants undergo multi-visit endodontic retreatment where an intracanal medicament, either calcium hydroxide or Bio-C Temp, is placed between treatment sessions to manage postoperative pain.

Initial treatment visit and 1 follow-up visit for medicament placement and assessment

Follow-up

Duration - 7 days

Participants record their postoperative pain intensity and analgesic consumption at predefined time points during the interappointment period to monitor pain levels and medication use.

Pain and analgesic use assessments at 12 hours, 24 hours, 3 days, 5 days, and 7 days post-treatment

Trial Site Locations

Total: 2 locations

1

Ankara University Faculty of Dentistry

Ankara, Ankara, Turkey (Türkiye), 06100

Actively Recruiting

2

Ankara University Faculty of Dentistry

Ankara, Ankara, Turkey (Türkiye), 06500

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Prevalence of endodontic flare-up following intracanal medicament placement in permanent teeth undergoing endodontic treatment - A systematic review.

Kuntal Sureshrao Wagh, Manjusha M Warhadpande, Darshan M Dakshindas

https://pubmed.ncbi.nlm.nih.gov/35722066

Postoperative Pain Following Single-Visit Versus Two-Visit Endodontic Retreatment - A Comparison of Inter-Appointment and Post-Obturation Periods: Randomised Clinical Trial.

Fulya Karaoğlan, Ayşenur Kiziltaş Gül, Mehmet Kemal Çalışkan

https://pubmed.ncbi.nlm.nih.gov/40801476

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.

Adile Esen Angın, Hicran Dönmez Özkan, İlkim Pınar Saral...

https://pubmed.ncbi.nlm.nih.gov/38849655

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.

Mohamed Omaia, Maged Negm, Yousra Nashaat...

https://pubmed.ncbi.nlm.nih.gov/41552268