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RecruitingNCT07585721(BCvsCaOH)Updated Sep 25, 2026

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

An interventional study of Calcium Hydroxide (Ca(OH)2) and Bioceramic Intracanal Medicament in Symptomatic Apical Periodontitis, sponsored by Future University in Egypt. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Future University in Egypt · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2026; still recruiting 5 months later.
Updated Sep 25, 2026Now RecruitingFirst site in Egypt+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Symptomatic Apical Periodontitis

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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
03

In context

Pain, Postoperative

5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.

This study's planned enrollment of 28 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Future University in Egypt is the lead sponsor of 104 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • Permanent mandibular molars diagnosis with Symptomatic Apical Periodontitis
  • Permanent molars without any anatomical variations or severe curvatures

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
28 participants (estimated)

Study arms

  • Experimental
    Calcium Hydroxide Group

    Meta Paste (Meta Biomed)

    Drug: Calcium Hydroxide (Ca(OH)2)

  • Experimental
    Bioceramic Group

    Bio-C Temp Angelus

    Drug: Bioceramic Intracanal Medicament

Interventions

  • 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

  • DrugBioceramic Intracanal Medicament

    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

06

What researchers measure

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.

    Time frame: one week

Secondary outcomes

  1. neurogenic biomarker Substance P Level

    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

    Time frame: one week after the pulp Extirpation

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — No individual participant data will be shared.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Sep 25, 2026
Sites
1 site added — first site in Egypt
Show site
  • Future University in Egypt - Faculty of Oral and Dental Medicine · Cairo, Egypt
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Not yet recruiting→Recruiting
    1 site added — first site in Egypt
    Show site
    • Future University in Egypt - Faculty of Oral and Dental Medicine · Cairo, Egypt
    + 5 other changes: verification date, date precision, responsible party, oversight details and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07585721
Responsible party
salma tarek abdullah (Principal Investigator, Future University in Egypt) — Principal investigator
First posted
May 14, 2026
Start date
Jun 1, 2026
Primary completion
Feb 1, 2027 (estimated)
Completion
Feb 1, 2027 (estimated)
Last update
Sep 25, 2026

Study contacts

Salma Tarek Abdullah, Bachelors degree
Contact
salma1319142066@gmail.com
+201060044225 ext. +201007510555
Adel Abdelwahed, Prof. Ass. of endodontic
principal investigator · Prof. Ass. of endodontic, faculty of Oral and Dental Medicine Future University in Egypt
Ahmed Amer ibrahim elwakad, Lecturer of Endodontics
principal investigator · Lecturer of Endodontics, Faculty of Oral and Dental Medicine, Future university in Egypt

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Calcium Hydroxide

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