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NCT Number: NCT07101029

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

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Bio-C Temp Intracanal Medication

Drug

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

Other names: Bioceramic intracanal dressing

Calcium Hydroxide Intracanal medication

Drug

Calcium Hydroxide intracanal dressing in the form of injectable premixed paste

Primary outcomes

  1. Intensity of post-operative pain

    Time frame: 6 hours post-instrumentation

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

  2. Intensity of post-operative pain

    Time frame: 12 hours post-instrumentation

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

  3. Intensity of post-operative pain

    Time frame: 24 hours post-instrumentation

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

  4. Intensity of post-operative pain

    Time frame: 48 hours post-instrumentation

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

  5. Intensity of post-operative pain

    Time frame: 6 hours post-obturation

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

  6. Intensity of post-operative pain

    Time frame: 12 hours post-obturation

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

  7. Intensity of post-operative pain

    Time frame: 24 hours post-obturation

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

  8. Intensity of post-operative pain

    Time frame: 48 hours post-obturation

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

Secondary outcomes

  1. Periapical MMP-9 level

    Time frame: at the first visit post- instrumentation

    Level Of MMP-9 Enzyme in the periapical tissue fluid, quantified by ELISA

  2. Periapical MMP-9 Level

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

    Level of MMP-9 enzyme in the periapical tissue fluid, Quantified by ELISA

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 3, 2025
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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