Postoperative Pain and Substance P Levels After Bioceramic vs Calcium Hydroxide Intracanal Medicaments in Symptomatic Apical Periodontitis ((BCvsCaOH))

May 10, 2026 updated by: salma tarek abdullah, Future University in Egypt

Clinical Evaluation of the Postoperative Pain and Substance P Levels Following the Use of Bioceramic Verses Calcium Hydroxide Intracanal Medicaments in Permanent Mandibular Molars With Symptomatic Apical Periodontitis

Clinical Evaluation of the Postoperative Pain and Substance P levels Following the use of Bioceramic verses Calcium Hydroxide Intracanal Medicaments in Permanent Mandibular molars with Symptomatic Apical Periodontitis

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study aims to evaluate postoperative pain levels and Substance P expression following the use of two different intracanal medicaments: bioceramic materials and calcium hydroxide in permanent mandibular molars diagnosed with symptomatic apical periodontitis.

A total of 28 patients will be included in this study and randomly allocated into two equal groups (n=14 each). Group I will receive calcium hydroxide (Ca(OH)₂) as an intracanal medicament, while Group II will receive a bioceramic intracanal medicament.

Standardized endodontic procedures will be performed for all participants. Postoperative pain will be assessed using a visual analog scale (VAS) at different time intervals following treatment.

In addition, samples will be collected to evaluate Substance P levels as a biochemical marker associated with pain and inflammation.

The comparison between the two groups will help determine the effectiveness of each intracanal medicament in reducing postoperative pain and inflammatory response. The results of this study may contribute to improving clinical decision-making in endodontic therapy.

Study Type

Interventional

Enrollment (Estimated)

28

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 Contact

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • - Patients aged 18-45 years with no sex predilection
  • Medically free Patients with no systemic conditions that can affect post operative pain response.
  • Patients should not be taking any pain medications 24 hours before intervention
  • Positive patients' acceptance for participating in the study
  • Patient able to sign informed consent
  • Permanent mandibular molars diagnosis with Symptomatic Apical Periodontitis
  • Permanent molars without any anatomical variations or severe curvatures

Exclusion Criteria:

  • - Medically compromised patients
  • Patients who have received antibiotic therapy within the last 2 weeks.
  • Pregnant or lactating women.
  • Patients with known allergy to any of the irrigants used.
  • Patients with swelling or acute peri-apical abscess or fistulous tract.
  • Teeth that have:
  • Wide or open apex .
  • Vital pulp tissue .
  • Periodontally affected with grade 2or 3 mobility.
  • Non restorable teeth .
  • Abnormal anatomy and calcified canals .
  • Pervious root canal treatment.
  • severe curved canal
  • Buccolingual and mesiodistal radiographs were taken to evaluate the root canal anatomy

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Calcium Hydroxide Group
Meta Paste (Meta Biomed)
Drug: Calcium Hydroxide (Ca(OH)2)
Calcium hydroxide will be used as an intracanal medicament during root canal treatment in Permanent Mandibular molars with Symptomatic Apical Periodontitis
Other Names:
  • Meta paste - Meta Biomed
Experimental: Bioceramic Group
Bio-C Temp Angelus
Drug: Bioceramic Intracanal Medicament
Bioceramic material will be used as an intracanal medicament during root canal treatment in Permanent Mandibular molars with Symptomatic Apical Periodontitis
Other Names:
  • Bio- C temp - Angelus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of postoperative pain levels
Time Frame: one week
Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores will be recorded at 6 hours, 24 hours, 48 hours, 72 hours, and 7 days after treatment to compare postoperative pain levels between the two medicament groups and evaluate the correlation between Substance P reduction and pain perception.
one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neurogenic biomarker Substance P Level
Time Frame: one week after the pulp Extirpation
To compare the effectiveness of bio ceramic intracanal medicament (Bio-C Temp) and calcium hydroxide in reducing the neurogenic biomarker Substance P in periapical samples of molars diagnosed with symptomatic apical periodontitis
one week after the pulp Extirpation

Collaborators and Investigators

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

Sponsor

Future University in Egypt

Investigators

  • Principal Investigator: Adel Abdelwahed, Prof. Ass. of endodontic, Prof. Ass. of endodontic, faculty of Oral and Dental Medicine Future University in Egypt
  • Principal Investigator: Marwa Moataz abo shadi, Lecturer of Endodontics, Lecturer of Endodontics, Faculty of Oral and Dental Medicine, Future university in Egypt

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)

June 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

April 27, 2026

First Submitted That Met QC Criteria

May 10, 2026

First Posted (Actual)

May 14, 2026

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 10, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUE.REC(24)/2-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual participant data will be shared.

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.

Subscribe