One and Two-visit Root Canal Retreatment

One and Two-visit Root Canal Retreatment in Teeth With Periapical Lesion

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.

Study Overview

• Status: Completed
• Conditions: Root Canal Infection
• Intervention / Treatment: Other: One visit root canal retreatment; Other: Two visit root canal retreatment

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Izmir, Turkey
    • Ege University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: 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
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The presence or absence of clinical symptoms in clinical examination	All patients were called for follow up visits. The evaluation was performed by clinical examination. Clinical symptoms including presence of pain, tenderness to percussion and palpation, presence of sinus tract or swelling was detected and recorded as present or absent. If one of these symptoms recorded as present, it is considered as failure. If there is no symptom, it is considered as success.	24 months
The rate of radiographic healing of the periapical lesion.	Follow-up visits were performed for all patients in order to evaluate radiographic status. Changes in apical bone density indicating radiographic healing was assessed using Periapical Index (PAI) (Orstavik 1986) as the scoring system. PAI 1 and 2 considered as healed, reduction in the PAI score was considered as healing and persistence or increased in the PAI score (PAI 4 or 5) was considered as failure.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The level of postoperative pain	Postoperative pain after 12, 24 and 48 hours, was measured using a modified 4-grade visual analogue scale (VAS) ranging from 1 (no pain), 2 (mild pain), 3 (moderate pain/pain relieved by analgesics), to 4 (severe pain).	12hours-24hours and 48 hours

Collaborators and Investigators

• Sponsor: Ege University
• Investigators: Principal Investigator: Fulya Karaoglan, Ege University Faculty of Dentistry

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: November 17, 2021
• First Submitted That Met QC Criteria: November 27, 2021
• First Posted (Actual): November 30, 2021

Study Record Updates

• Last Update Posted (Actual): November 30, 2021
• Last Update Submitted That Met QC Criteria: November 27, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Root canal retreatment

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