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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control: Calcium Hydroxide | No Intervention | Non-setting Calcium Hydroxide | |
| Test: Triple Antibiotic Paste and Anti-Inflammatory Drug | Other | Mixture of ciprofloxacin, metronidazole and minocycline.and diclofenac potassium 50 mg (Catafast) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| triple antibiotic paste with an anti-inflammatory drug | Other | Mixture of ciprofloxacin, metronidazole and minocycline.and diclofenac potassium 50 mg (Catafast) |
|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41552268 | Derived | Omaia M, Negm M, Nashaat Y, Nabil N, Othman A. The effect of triple antibiotic paste as an intracanal medicament with an anti-inflammatory agent on post-operative pain of asymptomatic uniradicular necrotic teeth: a double blind randomized clinical trial. F1000Res. 2025 Dec 16;8:1687. doi: 10.12688/f1000research.19699.3. eCollection 2019. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control: Calcium Hydroxide | Non-setting Calcium Hydroxide |
| FG001 | Test: Triple Antibiotic Paste and Anti-Inflammatory Drug | Mixture of ciprofloxacin, metronidazole and minocycline.and diclofenac potassium 50 mg (Catafast) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control: Calcium Hydroxide | non setting calcium hydroxide |
| BG001 | Test: Triple Antibiotic Paste and Anti-Inflammatory Drug | Mixture of ciprofloxacin, metronidazole and minocycline.and diclofenac potassium 50 mg (Catafast) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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] ) | Posted | Mean | Standard Deviation | score on a scale | after 24, 48, and 72 hour from the end of the first visit. |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control: Calcium Hydroxide | non setting calcium hydroxide | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mohamed Omaia Ahmed | Cairo university | 00201224474609 | mohamed.omaia@dentistry.cu.edu.eg |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 24, 2018 | Aug 16, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
Mixture of ciprofloxacin, metronidazole and minocycline.and diclofenac potassium 50 mg (Catafast)
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | CFU/ml | before and after mechanical preparation (at day 0) and after 72 hour from placement of the intracanal medication. |
|
|
|
|
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Test: Triple Antibiotic Paste and Anti-Inflammatory Drug | Mixture of ciprofloxacin, metronidazole and minocycline.and diclofenac potassium 50 mg (Catafast) | 0 | 41 | 0 | 41 | 0 | 41 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| S3 |
|
0.467 for S2, Significant at P ≤ 0.05 |
| Superiority |
| Chi-squared | 0.01 | 0.01 for S3 Significant at P ≤ 0.05 | Superiority |