The Effect of Canal Dryness on the Quality of Obturation

August 2, 2023 updated by: shehabeldin saber, British University In Egypt

The Effect of Different Canal Dryness Protocols on the Quality of Matched Single Cone Obturation: A Randomized Clinical Trial

The goal of this clinical trial is to evaluate root canal obturation quality. The questions to answer are

  • what is the best protocol for canal dryness before obturation ?
  • Is compaction necessary ? Volunteer participants will perform root canal treatment in teeth planned for extraction due to orthodontic reasons

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • El-Sherouk
      • Cairo, El-Sherouk, Egypt, 11837
        • Faculty of Dentistry, The British University in Egypt

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • healthy males and females (Category: American Society of Anesthesiologists class 1)
  • aged 23-25 years
  • presenting with sound maxillary premolars (non-carious and not previously restored)
  • a radiographically visible root canal outline

Exclusion Criteria:

  • dental students of any level were not eligible to avoid including vulnerability factors.
  • pregnant volunteers
  • volunteers with complicating systemic disease (ASA 3-6)
  • poor oral hygiene
  • periodontal disease (probing depth >3 mm) related to the tooth

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: Total dryness
matching paper points are used till they come out completely dry
Procedure: Root canal obturation
Root canal dryness
Active Comparator: Partial dryness
a single matching cone is inserted in the canal for 3 seconds only.
Procedure: Root canal obturation
Root canal dryness

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
obturation quality
Time Frame: after 30 days
percentage of voids within the filling by micro CT analysis
after 30 days

Collaborators and Investigators

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

Sponsor

British University In Egypt

Investigators

  • Principal Investigator: Shehabeldin Saber, phD, Faculty of Dentistry, The British University in Egypt

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)

January 1, 2022

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

March 29, 2023

First Submitted That Met QC Criteria

March 29, 2023

First Posted (Actual)

April 11, 2023

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

August 2, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 21-038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

after study completion

IPD Sharing Access Criteria

PI email

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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