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Not yet recruiting 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

Early Phase I Interventional Intracanal Dressing Apical Periodontitis Calcium Hydroxide Biomarkers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bio-C Temp Intracanal Medication, Calcium Hydroxide Intracanal medication.
Who it may be relevant to
Registry conditions: Intracanal Dressing, Apical Periodontitis, Calcium Hydroxide, Biomarkers. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

  • Drug Bio-C Temp Intracanal Medication
    Bio-C Temp Bioceramic intracanal dressing in the form of injectable premixed paste
  • Drug Calcium Hydroxide Intracanal medication
    Calcium Hydroxide intracanal dressing in the form of injectable premixed paste

Primary outcome measures

  • Intensity of post-operative pain [Time frame: 6 hours post-instrumentation]
  • Intensity of post-operative pain [Time frame: 12 hours post-instrumentation]
  • Intensity of post-operative pain [Time frame: 24 hours post-instrumentation]
  • Intensity of post-operative pain [Time frame: 48 hours post-instrumentation]
  • Intensity of post-operative pain [Time frame: 6 hours post-obturation]
  • Intensity of post-operative pain [Time frame: 12 hours post-obturation]
  • Intensity of post-operative pain [Time frame: 24 hours post-obturation]
  • Intensity of post-operative pain [Time frame: 48 hours post-obturation]
Secondary outcome measures (2)
  • Periapical MMP-9 level [Time frame: at the first visit post- instrumentation]
  • Periapical MMP-9 Level [Time frame: After 1 week at the second visit (pre-obturation)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07101029 · MennaalaaCU25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗