Effect of Bio-C Temp Versus Calcium Ydroxide as Intracanal Dressings on Postoperative Pain Intensity and Periapical MMP-9 Level in Patients With Necrotic Pulp

Not Applicable

Not yet recruiting

• Conditions: Intracanal Dressing; Inflammatory Mediators; Apical Periodontitis; Calcium Hydroxide; Biomarkers
• Interventions: Drug: Bio-C Temp Intracanal Medication; Drug: Calcium Hydroxide Intracanal medication

• Registration Number: NCT07101029
• Lead Sponsor: Cairo University

Brief Summary

To compare the effect of Bio-C Temp Bioceramic intracanal dressing versus calcium hydroxide as intracanal medicaments on:

* Intensity of postoperative pain

* levels of MMP -9 in Periapical Fluids.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-25
• Study First Submitted QC: 2025-07-28
• Last Update Submitted: 2025-07-28
• Study Start: 2025-08-01
• Study First Posted: 2025-08-03
• Last Update Posted: 2025-08-03
• Primary Completion: 2026-07
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Age between 18-50 years old.

2. Males and females.

3. Healthy patients categorized as I or II according to The American Society of Anesthesiologists.

   (ASA I or II), with no underlying allergies.

4. Single-rooted mandibular premolar teeth, having single root canal:

   • Diagnosed clinically with pulp necrosis.
   • Absence of spontaneous pulpal pain.
   • Slight widening in the periodontal membrane space or with periapical radiolucency not exceeding 2*2 mm radiographically.

5. Patients accepting to participate in the trial.

6. Patients who can understand pain scale and can sign the informed consent

Exclusion Criteria

1. Medically compromised patients having significant systemic disorders (ASA III or IV).
2. Pregnant females.
3. If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively as it might alter their pain perception.
4. Teeth with multiple canals. 9
5. Teeth that show association with acute periapical abscess, swelling or fistulous tract.
6. Teeth with vital pulp.
7. Non-restorable teeth or teeth that could not be adequately isolated with a rubber dam.
8. Immature teeth.
9. Teeth with greater than grade I mobility or pocket depth greater than 4 mm.
10. Teeth showing radiographic evidence of external or internal root resorption, vertical root fracture, perforation or calcification.
11. Patients with two or more adjacent teeth requiring endodontic treatment.
12. Patients reporting bruxism, clenching or TMJ problems.
13. Inability to perceive the given instructions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bio-C Temp	Bio-C Temp Intracanal Medication	This group will Receive Bio-C Temp Bioceramic paste as intracanal dressing
Calcium Hydroxide	Calcium Hydroxide Intracanal medication	This group will Receive Calcium Hydroxide paste as intracanal dressing

Primary Outcome Measures

Name	Time	Method
Intensity of post-operative pain	48 hours post-obturation	Intensity of post-operative pain as measured by Numerical Rating Scale (NRS)

Secondary Outcome Measures

Name	Time	Method
Periapical MMP-9 level	at the first visit post- instrumentation	Level Of MMP-9 Enzyme in the periapical tissue fluid, quantified by ELISA
Periapical MMP-9 Level	After 1 week at the second visit (pre-obturation)	Level of MMP-9 enzyme in the periapical tissue fluid, Quantified by ELISA