Single Versus Multiple Visits Endodontic Treatment

Study Overview
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Brief Summary
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Healing rate after single visit or multiple visit endodontic treatment using triple paste intracanal medicament will be assessed both clinically and radio-graphically for follow-up period up to one year

Detailed Description
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Patients with necrotic teeth with apical periodontitis will be selected according to the eligibility criteria and patients are then randomized to either single visit or multiple visit using triple paste intracanal medicament. Postoperative pain will then assessed using numerical rating scale after 1, 2, 3 and 7 days post-instrumentation. Radiographic healing will be assessed every 3 months up to one year.

Official Title
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Healing Rates After Single Versus Multiple Visits Endodontic Treatment of Necrotic Teeth With Apical Periodontitis: A Randomized Clinical Trial

Conditions
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Periapical Periodontitis

Intervention / Treatment
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* Drug: mixture of metronidazole, ciprofloxacin, and minocycline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients; age between 16-55 years old. Males or Females. Maxillary or mandibular single-root tooth or a multi-rooted tooth with: Non-vital response of pulp tissue. Radiographic evidence of periapical lesions (minimum size 2.0 mm × 2.0 mm) related to one root in case of multi-rooted teeth. Asymptomatic patients. Positive patients' acceptance for participation in the study. Exclusion Criteria: Primary teeth, and permanent teeth with immature apex. Teeth previously accessed or endodontically treated. Patients with diabetes and immune-compromising disease. Patients allergic to metronidazole, ciprofloxacin, or minocycline. Vital cases or necrotic without periapical lesion. Pregnant women. Teeth with unfavorable conditions for rubber-dam application. Tooth associated with vertical root fracture, coronal perforation, calcification and external or internal root resorption.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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 |
| --- | --- |
| Active Comparator: multiple visit<br>multiple visit root canal treatment with triple antibiotic paste intracanal medication (a mixture of metronidazole, ciprofloxacin, and minocycline) | Drug: mixture of metronidazole, ciprofloxacin, and minocycline<br>* placement of intracanal medication<br>* Other names: no other names;|
| No Intervention: single visit<br>single visit root canal treatment without any intra-canal medication | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain | using numerical rating scale from 0-10 | 24 hours | 
| postoperative pain | using numerical rating scale from 0-10 | 48 hours | 
| postoperative pain | using numerical rating scale from 0-10 | 72 hours | 
| postoperative pain | using numerical rating scale from 0-10 | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic healing | using digital radiography | 3 months | 
| Radiographic healing | using digital radiography | 6 months | 
| Radiographic healing | using digital radiography | 9 months | 
| Radiographic healing | using digital radiography | 12 months |