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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.

This study is not yet open for participant recruitment.
Verified October 2016 by mohamed omaia ahmed salah, Cairo University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02907489
First Posted: September 20, 2016
Last Update Posted: October 19, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
mohamed omaia ahmed salah, Cairo University
  Purpose
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 Intervention
Asymptomatic Necrotic Teeth Other: triple antibiotic paste with an anti-inflammatory drug

Study Type: Interventional
Study Design: 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).

Resource links provided by NLM:


Further study details as provided by mohamed omaia ahmed salah, Cairo University:

Primary Outcome Measures:
  • Change of post operative pain [ Time Frame: after 24, 48, and 72 hour from the end of the first visit. ]
    Visual Analogue Scale (VAS)


Secondary Outcome Measures:
  • Intracanal bacterial reduction [ 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


Estimated Enrollment: 84
Study Start Date: October 2016
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group 1
non setting calcium hydroxide intracanal medication.
Other: triple antibiotic paste with an anti-inflammatory drug
Mixture of ciprofloxacin, metronidazole and minocycline.and diclofenac potassium 50 mg (Catafast)
Group 2
triple antibiotic paste with an anti-inflammatory drug
Other: triple antibiotic paste with an anti-inflammatory drug
Mixture of ciprofloxacin, metronidazole and minocycline.and diclofenac potassium 50 mg (Catafast)

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.
  Eligibility

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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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

Responsible Party: mohamed omaia ahmed salah, Assistant lecturer in Endodontic departement October 6 University, Cairo University
ClinicalTrials.gov Identifier: NCT02907489     History of Changes
Other Study ID Numbers: CEBD-CU-2016-09-194
First Submitted: September 8, 2016
First Posted: September 20, 2016
Last Update Posted: October 19, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by mohamed omaia ahmed salah, Cairo University:
post operative pain
triple antibiotic paste
intracanal medication

Additional relevant MeSH terms:
Pain, Postoperative
Necrosis
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Anti-Bacterial Agents
Bacitracin
Neomycin
Polymyxin B
Bacitracin zinc, neomycin sulfate, polymyxin B, drug combination
Antibiotics, Antitubercular
Anti-Inflammatory Agents
Anti-Infective Agents
Antitubercular Agents
Anti-Infective Agents, Local
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action