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One and Two-visit Root Canal Retreatment

NCT ID: NCT05137613

Last Updated: 2021-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2021-08-01

Brief Summary

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A hundred previously root canal treated asymptomatic single-rooted teeth with periapical lesions were treated in single versus multiple visit root canal retreatment. Half of the teeth were randomly assigned to the one-visit (OV) group. The other teeth were treated in two visits (TV). All patients were recalled and investigated clinically and radiographically for 24 months.

Detailed Description

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The aim of the study was to evaluate the radiographic evidence of periapical healing in previously root canal treated teeth with apical periodontitis treated in a single visit and to compare the results with conventional two-visit root canal treatment .100 asymptomatic single rooted teeth with periapical lesions were included. The root canal filling material was removed and reinstrumentation was performed using hand files with 2.5% sodium hypochlorite (NaOCl) and 5% ethylenediaminetetraacetic acid (EDTA) as irrigants. Half of the teeth were randomly assigned to the one-visit (OV) group. The other teeth were treated in two visits (TV), after completion of root canal instrumentation calcium hydroxide paste was placed into the root canal and root canal obturation was performed in second visit. All patients were recalled and investigated clinically and radiographically for 24 months. Changes in apical bone density indicating radiographic healing were evaluated.

Conditions

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Root Canal Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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One visit root canal retreatment

The teeth were treated in one-visit (OV) root canal retreatment. Final root canal irrigation was performed with 5% EDTA, followed by 2.5% NaOCl and received an additional final rinse with 2% CHX before obturation.

Group Type ACTIVE_COMPARATOR

One visit root canal retreatment

Intervention Type OTHER

The teeth were treated in one-visit (OV) root canal retreatment. Final root canal irrigation was performed with 5% EDTA, followed by 2.5% NaOCl and received an additional final rinse with 2% CHX before obturation

Two visit root canal retreatment

The teeth were treated in two visit (TV) root canal retreatment. After completion of root canal instrumentation, calcium hydroxide (CH) paste was placed into the root canal. In second visit, all root canals were irrigated with 5% EDTA followed by 2.5% NaOCl before obturation.

Group Type ACTIVE_COMPARATOR

Two visit root canal retreatment

Intervention Type OTHER

The teeth were treated in two visit (TV) root canal retreatment. After completion of root canal instrumentation, calcium hydroxide (CH) paste was placed into the root canal. In second visit, all root canals were irrigated with 5% EDTA followed by 2.5% NaOCl before obturation.

Interventions

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One visit root canal retreatment

The teeth were treated in one-visit (OV) root canal retreatment. Final root canal irrigation was performed with 5% EDTA, followed by 2.5% NaOCl and received an additional final rinse with 2% CHX before obturation

Intervention Type OTHER

Two visit root canal retreatment

The teeth were treated in two visit (TV) root canal retreatment. After completion of root canal instrumentation, calcium hydroxide (CH) paste was placed into the root canal. In second visit, all root canals were irrigated with 5% EDTA followed by 2.5% NaOCl before obturation.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* with a non-contributory medical history,
* single-rooted teeth with periapical lesions,
* previously root canal treated but no reduction in the lesion after the treatment
* diagnosed as asymptomatic apical periodontitis

Exclusion Criteria

* clinical symptoms, drainage,
* more than 5 mm loss of periodontal attachment,
* non-restorable tooth
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ege University

OTHER

Sponsor Role lead

Responsible Party

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Seniha Miçooğulları Kurt

Asst. Assoc. Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fulya Karaoglan

Role: PRINCIPAL_INVESTIGATOR

Ege University Faculty of Dentistry

Locations

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Ege University

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Eyuboglu TF, Olcay K, Ozcan M. A clinical study on single-visit root canal retreatments on consecutive 173 patients: frequency of periapical complications and clinical success rate. Clin Oral Investig. 2017 Jun;21(5):1761-1768. doi: 10.1007/s00784-016-1957-2. Epub 2016 Sep 22.

Reference Type BACKGROUND
PMID: 27660159 (View on PubMed)

He J, White RK, White CA, Schweitzer JL, Woodmansey KF. Clinical and Patient-centered Outcomes of Nonsurgical Root Canal Retreatment in First Molars Using Contemporary Techniques. J Endod. 2017 Feb;43(2):231-237. doi: 10.1016/j.joen.2016.10.029.

Reference Type BACKGROUND
PMID: 28132709 (View on PubMed)

Zhang MM, Fang GF, Chen XT, Liang YH. Four-year Outcome of Nonsurgical Root Canal Retreatment Using Cone-beam Computed Tomography: A Prospective Cohort Study. J Endod. 2021 Mar;47(3):382-390. doi: 10.1016/j.joen.2020.10.020. Epub 2020 Oct 29.

Reference Type BACKGROUND
PMID: 33130061 (View on PubMed)

Other Identifiers

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Root canal retreatment

Identifier Type: -

Identifier Source: org_study_id