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

NCT07585721 | Not Yet Recruiting DMC

• 1 other identifier: FUE.REC(24)/2-2026
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Symptomatic Apical Periodontitis

Keywords

Postoperative Pain; Substance P; Calcium Hydroxide; Bioceramic intra-canal medication; BIO-C TEMP; Mandibular Molars; Intra canal medication; Endodontics; Root Canal Treatment; inflammatory mediators; Symptomatic Apical Periodontitis

Outcome Measures

Primary Outcomes (1)

• Assessment of postoperative pain levels

  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 Outcomes (1)

• neurogenic biomarker Substance P Level

  one week after the pulp Extirpation

Study Arms (2)

Calcium Hydroxide Group

EXPERIMENTAL

Meta Paste (Meta Biomed)

Drug: Calcium Hydroxide (Ca(OH)2)

Bioceramic Group

EXPERIMENTAL

Bio-C Temp Angelus

Drug: Bioceramic Intracanal Medicament

Interventions

Calcium Hydroxide (Ca(OH)2) DRUG

Calcium hydroxide will be used as an intracanal medicament during root canal treatment in Permanent Mandibular molars with Symptomatic Apical Periodontitis

Also known as: Meta paste - Meta Biomed

Calcium Hydroxide Group

Bioceramic Intracanal Medicament DRUG

Bioceramic material will be used as an intracanal medicament during root canal treatment in Permanent Mandibular molars with Symptomatic Apical Periodontitis

Also known as: Bio- C temp - Angelus

Bioceramic Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Future University in Egypt: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Calcium Hydroxide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Salma Tarek Abdullah, Bachelors degree

CONTACT

+201060044225; salma1319142066@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical student , future university

Model Details: Participants will be randomly assigned into two parallel groups to receive either calcium hydroxide or bioceramic intracanal medicament.

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 14, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share