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

Cairo University (CU)

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Apical Periodontitis; Biomarkers; Intracanal Dressing; Inflammatory Mediators; Calcium Hydroxide

Treatments: Drug: Bio-C Temp Intracanal Medication; Drug: Calcium Hydroxide Intracanal medication

Study type: Interventional

Funder types: Other

Identifiers

NCT07101029

MennaalaaCU25

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Bio-C Temp

Experimental group

Description:

This group will Receive Bio-C Temp Bioceramic paste as intracanal dressing

Treatment:

Drug: Bio-C Temp Intracanal Medication

Calcium Hydroxide

Active Comparator group

Description:

This group will Receive Calcium Hydroxide paste as intracanal dressing

Treatment:

Drug: Calcium Hydroxide Intracanal medication