Retrospective Assessment of Root Canal Retreatment Performed in Single Visit

February 11, 2021 updated by: Hend Mahmoud Abou El Nasr, Dubai Health Authority

Outcome of Root Canal Retreatment Performed in Single Visits. A Retrospective Study

In cases refractory to initial root canal therapy in which a decision is made to perform nonsurgical retreatment, the patient has the right to know the prognosis of the proposed treatment and clinicians must be able to provide this information based on the best available data. The literature answered this question when the treatment was performed in multiple visits; however, little information exists when single visit root canal retreatment was performed. Therefore, the aim of the present study is to assess the clinical and radiographic outcome of root canal retreatment performed in single visits in endodontic clinics of Dubai Health Authority (DHA).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The present study is designed to assess the clinical and radiographic outcome of root canal retreatment performed in single visits in endodontic clinics of Dubai Health Authority (DHA). This is a retrospective study where patients' treatment data will be collected and outcome criteria will be applied blindly.

The sample in this retrospective study will be selected from those patients who have undergone single visit endodontic retreatment at the DHA Endodontics clinics from January 2018, through December 2019. The teeth under investigation will be tracked in the database starting from completion of retreatment for at least 6 months, and the percentages of teeth that were retained or underwent additional procedures such as apical surgery or extraction will be recorded.

The clinical and radiographic assessment at baseline and at recall documented in clinical notes, and all data will be collected using a standardized proforma.

The quality of the existing root canal fillings and the status of the periapical tissues will be determined according to the PAI by 2 calibrated independent observers using the periapical radiographs.

A. Periapical index (PAI) The index is a radiographic method of interpretation that consists of 5 categories, numbered 1-5.

B. Quality of root canal filling

Three criteria were used to assess the quality of the existing root canal fillings as follows:

Length of root canal filling: root filling ending ≤2 mm from the radiographic apex, root filling ending >2 mm from the radiographic apex, or root filling at the radiographic apex (flush).

Density of root canal filling: the presence or absence of voids in the root filling or between the root filling and root canal walls.

Taper of the root canal filling: consistent taper from the orifice to the apex or no consistent taper from the orifice to the apex

The preoperative diagnosis is determined based on clinical and radiographic findings using the American Association of Endodontists Consensus Conference-recommended diagnostic terminology.

Retreatment Procedures

Endodontic retreatment of all cases was conducted in a single visit by endodontic specialists according to the contemporary standards of endodontic therapy.

Only those patients with at least 6 months of clinical and radiographic follow-up were included. When patients returned for recalls, one or multiple (in mutirooted teeth) periapical radiographs were taken.

Follow up

Recall appointments included a radiographic and clinical examination of the treated tooth. The examination was documented and included any signs or symptoms, the presence of a sinus tract, sensitivity to percussion and palpation, swelling, periodontal pockets, or a history of pain.

Periapical radiographs will be evaluated by 2 examiners.

The treatment outcomes will be classified into 3 categories according to the following definitions:

Healed: Functional, asymptomatic teeth with no or minimal radiographic periradicular pathosis (radiolucency) Nonhealed: Nonfunctional, symptomatic teeth with or without radiographic periradicular pathosis or asymptomatic teeth with unchanged, new, or enlarged radiographic periradicular pathosis (radiolucency) Healing: Teeth that are asymptomatic and functional with a decreased size of radiographic periradicular pathosis (radiolucency) .

Collecting data into a recording sheet:

The patients' treatment data will be collected continuously for at least 6 months in the database, and outcome criteria will applied blindly. The teeth will be tracked in the database during the entire period.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

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

Study Contact

Study Locations

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients who underwent root canal retreatment in single visit in endodontic clinics of Dubai Health Authority (DHA).

Description

Inclusion Criteria:

  • Root canal retreatment cases performed in single visits
  • Age ranging from 18 - 70 years
  • Follow up period of at least 6 months

Exclusion Criteria:

A case will be excluded from the study if the case was under 18 years of age or followed up period for less than 6 months.

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
exposure group
subjects in this group are single visit
Procedure: single visit root canal retreatment
cases that were subject to root canal retreatment performed in single visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain or swelling
Time Frame: 6 months to 2 years
dichotomized into yes or no
6 months to 2 years
radiographic
Time Frame: 6 months to 2 years
Periapical Index scoring scoring the health of the periapical area using a 5-scale scoring system (from 1 to 5); where1 represents normal periapical tissue while score 5 denotes established apical periodontitis
6 months to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tooth survival
Time Frame: 6 months to 2 years
Number of teeth retained or underwent additional procedures such as apical surgery and extraction
6 months to 2 years

Collaborators and Investigators

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

Sponsor

Dubai Health Authority

Investigators

  • Principal Investigator: Hend Abou El Nasr, PhD, Cairo University and Dubai Health Authority

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 27, 2021

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

January 31, 2021

First Submitted That Met QC Criteria

February 6, 2021

First Posted (Actual)

February 9, 2021

Study Record Updates

Last Update Posted (Actual)

February 15, 2021

Last Update Submitted That Met QC Criteria

February 11, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DSREC-01/2021_11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

Clinical Trials on Root Canal Retreatment

Clinical Trials on single visit root canal retreatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe