Clinical trial NCT05582421: Effect of Diclofenac Sodium Versus Calcium Hydroxide as Intracanal Medication on the Intensity of Postoperative Pain, Bacterial Load Reduction and MMP-9 Levels in Patients With Necrotic Pulp.
Official title: Effect of Diclofenac Sodium Versus Calcium Hydroxide as Intracanal Medication on the Intensity of Postoperative Pain, Bacterial Load Reduction and MMP-9 Levels in Patients With Necrotic Pulp: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Necrotic Pulp
Apical Periodontitis
Keywords: necrosis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-10-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Trial Design: Randomized Clinical Trial (Parallel Group) Two Arms Allocation Ratio: 1:1 Framework: Superiority
Primary purpose: TREATMENT

Brief summary: the aim of this study is to compare the effect of using Diclofenac Sodium Versus Calcium Hydroxide as Intracanal medication on intensity of postoperative pain, bacterial load reduction after root canal preparation and periapical matrix metalloproteinase 9 level (MMP-9) post-instrumentation and pre-obturation in teeth with necrotic pulp

Detailed description: To compare the effect of diclofenac sodium versus calcium hydroxide as intra canal medication on:

- Primary Outcome Intensity of postoperative pain will be measured using numerical rating scale (NRS) at 6, 12, 24 and 48- hours post-instrumentation and at 6, 12, 24 and 48 hours post-obturation.

Secondary Outcome 1 Bacterial load reduction will be determined by bacterial counting using agar culture technique after root canal preparation (CFU/ml).

Secondary Outcome 2 Periapical MMP-9 level will be determined post-instrumentation and pre-obturation by ELISA.

Eligibility criteria: Inclusion Criteria:

-

Inclusion criteria:

* Patients who are free from any physical or mental handicapping condition with no underlying systemic disease.
* Age between 18-50 years.
* Males \& Females.
* Mandibular single rooted permanent premolar teeth:

  * Diagnosed clinically with pulp necrosis.
  * Absence of spontaneous pain.
  * Positive pain on percussion denoting apical periodontitis.
  * Slight widening in the periodontal membrane space or with periapical radiolucency not exceeding 2\*2 mm radiographically.
* Patients' acceptance to participate in the trial.
* Patients who can understand pain scale and can sign the informed consent

Exclusion Criteria:

* Medically compromised patients
* Pregnant women.
* If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively.
* Patients reporting bruxism or clenching.
* Teeth that show association with acute periapical abscess and swelling.
* Greater than grade I mobility or pocket depth greater than 5mm.
* Non-restorable teeth
* Teeth with vital pulp.
* Immature teeth.
* Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.

Primary outcomes:
measure: change in Intensity of postoperative pain
timeFrame: 6,12.24.48 hours
Secondary outcomes:
measure: Bacterial load reduction
timeFrame: 7 days
Other outcomes:
measure: Periapical MMP-9 level
timeFrame: 7 days
Locations:
Study officials:
References: