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

Phase 1

Completed

• Conditions: Asymptomatic Necrotic Teeth
• Interventions: Other: triple antibiotic paste with an anti-inflammatory drug

• Registration Number: NCT02907489
• Lead Sponsor: Cairo University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-09-08
• Study First Submitted QC: 2016-09-15
• Study First Posted: 2016-09-20
• Study Start: 2016-10
• Primary Completion: 2018-04
• Study Completion: 2018-07
• Results First Submitted: 2019-07-11
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-21
• Last Update Submitted: 2019-09-21
• Results First Posted: 2019-09-24
• Last Update Posted: 2019-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

1. Subject's age between 18-50 years.
2. Both male and female subjects.
3. Medically free and healthy subjects.
4. Mandibular and maxillary single rooted teeth.
5. Asymptomatic non vital teeth.

Exclusion Criteria

1. Teeth with acute dentoalveolar abscess.
2. Subjects having more than one tooth that require root canal treatment.
3. Subjects that have taken analgesic, anti-inflammatory or antibiotic drugs during the 10 days prior to the start of treatment.
4. Pregnant females.
5. Subjects with systemic diseases who have endocrine diseases, Infectious diseases or Psychological disturbance.
6. Teeth with periodontal disease or pulp calcification.
7. Subjects taking chronic pain medications.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test: Triple Antibiotic Paste and Anti-Inflammatory Drug	triple antibiotic paste with an anti-inflammatory drug	Mixture of ciprofloxacin, metronidazole and minocycline.and diclofenac potassium 50 mg (Catafast)

Primary Outcome Measures

Name	Time	Method
Post Operative Pain	after 24, 48, and 72 hour from the end of the first visit.	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 \[8-10\] )

Secondary Outcome Measures

Name	Time	Method
Intracanal Bacterial Count	before and after mechanical preparation (at day 0) and after 72 hour from placement of the intracanal medication.	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)