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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

Effect of Bio-C Temp Versus Calcium Hydroxide as an Intracanal Dressing on Postoperative Pain Intensity and Periapical MMP-9 Level in Patients With Necrotic Pulp: A Randomized Clinical Trial

Status
Not yet recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07101029
Enrollment
30
Registered
2025-08-03
Start date
2025-08-31
Completion date
2026-07-31
Last updated
2025-08-03

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

Conditions

Intracanal Dressing, Apical Periodontitis, Calcium Hydroxide, Biomarkers, Inflammatory Mediators

Keywords

Bio-C Temp, Calcium Hydroxide, Intracanal medicament, Matrix Metalloproteinase 9, Biomarkers, Post operative pain

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.

Interventions

Bio-C Temp Bioceramic intracanal dressing in the form of injectable premixed paste

Calcium Hydroxide intracanal dressing in the form of injectable premixed paste

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Intensity of post-operative pain6 hours post-instrumentationIntensity of post-operative pain as measured by Numerical Rating Scale (NRS)

Secondary

MeasureTime frameDescription
Periapical MMP-9 levelat the first visit post- instrumentationLevel Of MMP-9 Enzyme in the periapical tissue fluid, quantified by ELISA
Periapical MMP-9 LevelAfter 1 week at the second visit (pre-obturation)Level of MMP-9 enzyme in the periapical tissue fluid, Quantified by ELISA

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026