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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02907489
Recruitment Status : Completed
First Posted : September 20, 2016
Results First Posted : September 24, 2019
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
mohamed omaia ahmed salah, 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.

Condition or disease Intervention/treatment Phase
Asymptomatic Necrotic Teeth Other: triple antibiotic paste with an anti-inflammatory drug Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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).
Study Start Date : October 2016
Actual Primary Completion Date : April 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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




Primary Outcome Measures :
  1. Post Operative Pain [ Time Frame: 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 :
  1. Intracanal Bacterial Count [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 Documents (Full-Text)

Documents provided by mohamed omaia ahmed salah, Cairo University:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

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Responsible Party: mohamed omaia ahmed salah, Assistant lecturer in Endodontic departement October 6 University, Cairo University
ClinicalTrials.gov Identifier: NCT02907489    
Other Study ID Numbers: CEBD-CU-2016-09-194
First Posted: September 20, 2016    Key Record Dates
Results First Posted: September 24, 2019
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by mohamed omaia ahmed salah, Cairo University:
post operative pain
triple antibiotic paste
intracanal medication
Additional relevant MeSH terms:
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Pain, Postoperative
Necrosis
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Anti-Bacterial Agents
Anti-Inflammatory Agents
Anti-Infective Agents