Effect of Triple Antibiotic Paste as an Intracanal Medication With an Anti-Inflammatory Drug on Post-operative Pain.

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the use of triple antibiotic paste as intracanal medication with an anti-inflammatory drug, compared to a calcium hydroxide will reduce postoperative pain and intracanal bacteria or not in patients with asymptomatic necrotic teeth.

Detailed Description
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This trial is aiming to answer a clinical question whether in patients with asymptomatic necrotic teeth, the use of triple antibiotic paste as intracanal medication with an anti-inflammatory drug, compared to a calcium hydroxide, reduce postoperative pain and intracanal bacteria or not? trial design will be Randomized, controlled, double blinded, unicenter, parallel, two-arm, superiority trial with 1:1 allocation ratio.

Official Title
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The Effect of Triple Antibiotic Paste as an Intracanal Medication With an Anti-Inflammatory Drug on Post-Operative Pain of Asymptomatic Uniradicular Necrotic Teeth (A Double Blind Randomized Clinical Trial).

Conditions
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Asymptomatic Necrotic Teeth

Intervention / Treatment
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* Other: triple antibiotic paste with an anti-inflammatory drug


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject's age between 18-50 years. Both male and female subjects. Medically free and healthy subjects. Mandibular and maxillary single rooted teeth. Asymptomatic non vital teeth. Exclusion Criteria: Teeth with acute dentoalveolar abscess. Subjects having more than one tooth that require root canal treatment. Subjects that have taken analgesic, anti-inflammatory or antibiotic drugs during the 10 days prior to the start of treatment. Pregnant females. Subjects with systemic diseases who have endocrine diseases, Infectious diseases or Psychological disturbance. Teeth with periodontal disease or pulp calcification. Subjects taking chronic pain medications.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control: Calcium Hydroxide<br>Non-setting Calcium Hydroxide | |
| Other: Test: Triple Antibiotic Paste and Anti-Inflammatory Drug<br>Mixture of ciprofloxacin, metronidazole and minocycline.and diclofenac potassium 50 mg (Catafast) | Other: triple antibiotic paste with an anti-inflammatory drug<br>* Mixture of ciprofloxacin, metronidazole and minocycline.and diclofenac potassium 50 mg (Catafast)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Operative Pain | Visual Analogue Scale (VAS) of post operative pain (The VAS consisted of a 100 mm horizontal ruler without numbers except a 0 at its first part and a 10 in the last part. With 0 indicating the best outcome while 10 the worst outcome. The subjects were asked to mark the point that was equivalent to their pain intensity. The pain levels were classified as no pain [0], mild pain [1-3], moderate pain [4-7] or severe pain [8-10] ) | after 24, 48, and 72 hour from the end of the first visit. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intracanal Bacterial Count | Colony forming units per milliliter of blood agar medium before root canal preparation (S1), after root canal preparation (S2) and after intracanal medication application for 72 hours (S3) | before and after mechanical preparation (at day 0) and after 72 hour from placement of the intracanal medication. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post operative pain, triple antibiotic paste, intracanal medication