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OpenTrials
Completed

NCT Number: NCT02947763

Single Versus Multiple Visits Endodontic Treatment

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

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Key information

Age range

16 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mixture of metronidazole, ciprofloxacin, and minocycline

Drug

placement of intracanal medication

Other names: no other names

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 28, 2016
Registry last updated
Jul 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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