Single Versus Multiple Visits Endodontic Treatment

July 10, 2019 updated by: Safeya AbdelRahaman Hassan, Cairo University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

44

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 55 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • no other names
No Intervention: single visit
single visit root canal treatment without any intra-canal medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain
Time Frame: 24 hours
using numerical rating scale from 0-10
24 hours
postoperative pain
Time Frame: 48 hours
using numerical rating scale from 0-10
48 hours
postoperative pain
Time Frame: 72 hours
using numerical rating scale from 0-10
72 hours
postoperative pain
Time Frame: 7 days
using numerical rating scale from 0-10
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic healing
Time Frame: 3 months
using digital radiography
3 months
Radiographic healing
Time Frame: 6 months
using digital radiography
6 months
Radiographic healing
Time Frame: 9 months
using digital radiography
9 months
Radiographic healing
Time Frame: 12 months
using digital radiography
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

October 26, 2016

First Submitted That Met QC Criteria

October 26, 2016

First Posted (Estimate)

October 28, 2016

Study Record Updates

Last Update Posted (Actual)

July 12, 2019

Last Update Submitted That Met QC Criteria

July 10, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBD-CU-2016-10-231

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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