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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| calcium hydroxide | Sham Comparator | calcium hydroxide will be placed as intracanal medication between visits. |
|
| diclofenac sodium | Active Comparator | diclofenac sodium will be placed as intracanal medication between visits |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac Sodium | Drug | intracanal medication |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in Intensity of postoperative pain | 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. | 6,12.24.48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Bacterial load reduction | bacterial counting using agar culture technique after root canal preparation (CFU/ml). | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Periapical MMP-9 level | determined post-instrumentation and pre-obturation by ELISA. | 7 days |
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:
Patients' acceptance to participate in the trial.
Patients who can understand pain scale and can sign the informed consent
Exclusion Criteria:
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Trial Design: Randomized Clinical Trial (Parallel Group) Two Arms Allocation Ratio: 1:1 Framework: Superiority
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| ID | Term |
|---|---|
| D003790 | Dental Pulp Necrosis |
| D010485 | Periapical Periodontitis |
| D009336 | Necrosis |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010483 | Periapical Diseases |
| D007571 | Jaw Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D010518 | Periodontitis |
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| ID | Term |
|---|---|
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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