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Single Versus Multiple Visits Endodontic Treatment

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ClinicalTrials.gov Identifier: NCT02947763
Recruitment Status : Not yet recruiting
First Posted : October 28, 2016
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):
Safeya AbdelRahaman Hassan, Cairo University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Periapical Periodontitis Drug: mixture of metronidazole, ciprofloxacin, and minocycline Phase 1

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Healing Rates After Single Versus Multiple Visits Endodontic Treatment of Necrotic Teeth With Apical Periodontitis: A Randomized Clinical Trial
Study Start Date : November 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: multiple visit
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
placement of intracanal medication
Other Name: no other names

No Intervention: single visit
single visit root canal treatment without any intra-canal medication



Primary Outcome Measures :
  1. postoperative pain [ Time Frame: 24 hours ]
    using numerical rating scale from 0-10

  2. postoperative pain [ Time Frame: 48 hours ]
    using numerical rating scale from 0-10

  3. postoperative pain [ Time Frame: 72 hours ]
    using numerical rating scale from 0-10

  4. postoperative pain [ Time Frame: 7 days ]
    using numerical rating scale from 0-10


Secondary Outcome Measures :
  1. Radiographic healing [ Time Frame: 3 months ]
    using digital radiography

  2. Radiographic healing [ Time Frame: 6 months ]
    using digital radiography

  3. Radiographic healing [ Time Frame: 9 months ]
    using digital radiography

  4. Radiographic healing [ Time Frame: 12 months ]
    using digital radiography



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult patients; age between 16-55 years old.
  2. Males or Females.
  3. 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.
  4. Positive patients' acceptance for participation in the study.

Exclusion Criteria:

  1. Primary teeth, and permanent teeth with immature apex.
  2. Teeth previously accessed or endodontically treated.
  3. Patients with diabetes and immune-compromising disease.
  4. Patients allergic to metronidazole, ciprofloxacin, or minocycline.
  5. Vital cases or necrotic without periapical lesion.
  6. Pregnant women.
  7. Teeth with unfavorable conditions for rubber-dam application.
  8. Tooth associated with vertical root fracture, coronal perforation, calcification and external or internal root resorption.

Responsible Party: Safeya AbdelRahaman Hassan, Assistant lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT02947763     History of Changes
Other Study ID Numbers: CEBD-CU-2016-10-231
First Posted: October 28, 2016    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Jaw Diseases
Periodontitis
Periapical Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periapical Diseases
Metronidazole
Minocycline
Ciprofloxacin
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors