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

NCT07101029 | Not Yet Recruiting Early Phase 1

• 1 other identifier: MennaalaaCU25
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (8)

• Intensity of post-operative pain

  Intensity of post-operative pain as measured by Numerical Rating Scale (NRS)

  6 hours post-instrumentation

• Intensity of post-operative pain

  Intensity of post-operative pain as measured by Numerical Rating Scale (NRS)

  12 hours post-instrumentation

• Intensity of post-operative pain

  Intensity of post-operative pain as measured by Numerical Rating Scale (NRS)

  24 hours post-instrumentation

• Intensity of post-operative pain

  Intensity of post-operative pain as measured by Numerical Rating Scale (NRS)

  48 hours post-instrumentation

• Intensity of post-operative pain

  Intensity of post-operative pain as measured by Numerical Rating Scale (NRS)

  6 hours post-obturation

• Intensity of post-operative pain

  Intensity of post-operative pain as measured by Numerical Rating Scale (NRS)

  12 hours post-obturation

• Intensity of post-operative pain

  Intensity of post-operative pain as measured by Numerical Rating Scale (NRS)

  24 hours post-obturation

• Intensity of post-operative pain

  Intensity of post-operative pain as measured by Numerical Rating Scale (NRS)

  48 hours post-obturation

Secondary Outcomes (2)

• Periapical MMP-9 level

  at the first visit post- instrumentation

• Periapical MMP-9 Level

  After 1 week at the second visit (pre-obturation)

Study Arms (2)

Bio-C Temp

EXPERIMENTAL

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

Drug: Bio-C Temp Intracanal Medication

Calcium Hydroxide

ACTIVE COMPARATOR

This group will Receive Calcium Hydroxide paste as intracanal dressing

Drug: Calcium Hydroxide Intracanal medication

Interventions

Bio-C Temp Intracanal Medication DRUG

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

Also known as: Bioceramic intracanal dressing

Bio-C Temp

Calcium Hydroxide Intracanal medication DRUG

Calcium Hydroxide intracanal dressing in the form of injectable premixed paste

Calcium Hydroxide

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18-50 years old.
• Males and females.
• Healthy patients categorized as I or II according to The American Society of Anesthesiologists.
• (ASA I or II), with no underlying allergies.
• 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.
• Patients accepting to participate in the trial.
• Patients who can understand pain scale and can sign the informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Periapical Periodontitis; Pain, Postoperative

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Lecturer

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 3, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 3, 2025

Record last verified: 2025-07