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NCT Number: NCT07585721

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Meta paste - Meta Biomed

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

Other names: Bio- C temp - Angelus

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Salma Tarek Abdullah, Bachelors degree

CONTACT

[email protected]

+201060044225 ext. +201007510555

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Registry information

Official study title

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

Acronym: (BCvsCaOH)

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 14, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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