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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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07585721
Acronym
(BCvsCaOH)
Enrollment
28
Registered
2026-05-14
Start date
2026-06-01
Completion date
2027-02-01
Last updated
2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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

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.

Interventions

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

DRUGBioceramic Intracanal Medicament

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

Sponsors

Future University in Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Assessment of postoperative pain levelsone weekPostoperative 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

MeasureTime frameDescription
neurogenic biomarker Substance P Levelone week after the pulp ExtirpationTo 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

Contacts

CONTACTSalma Tarek Abdullah, Bachelors degree
salma1319142066@gmail.com+201060044225
PRINCIPAL_INVESTIGATORAdel Abdelwahed, Prof. Ass. of endodontic

Prof. Ass. of endodontic, faculty of Oral and Dental Medicine Future University in Egypt

PRINCIPAL_INVESTIGATORMarwa Moataz abo shadi, Lecturer of Endodontics

Lecturer of Endodontics, Faculty of Oral and Dental Medicine, Future university in Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026