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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2026-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Intracanal Dressing Apical Periodontitis Calcium Hydroxide Biomarkers Inflammatory Mediators

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Bio-C Temp

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

Group Type EXPERIMENTAL

Bio-C Temp Intracanal Medication

Intervention Type DRUG

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

Calcium Hydroxide

This group will Receive Calcium Hydroxide paste as intracanal dressing

Group Type ACTIVE_COMPARATOR

Calcium Hydroxide Intracanal medication

Intervention Type DRUG

Calcium Hydroxide intracanal dressing in the form of injectable premixed paste

Interventions

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Bio-C Temp Intracanal Medication

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

Intervention Type DRUG

Calcium Hydroxide Intracanal medication

Calcium Hydroxide intracanal dressing in the form of injectable premixed paste

Intervention Type DRUG

Other Intervention Names

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Bioceramic intracanal dressing

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No