Clinical trial NCT05137613: One and Two-visit Root Canal Retreatment
Official title: One and Two-visit Root Canal Retreatment in Teeth With Periapical Lesion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Root Canal Infection
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2021-11-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The presence or absence of clinical symptoms in clinical examination
timeFrame: 24 months
measure: The rate of radiographic healing of the periapical lesion.
timeFrame: 24 months
Secondary outcomes:
measure: The level of postoperative pain
timeFrame: 12hours-24hours and 48 hours
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege University
Study officials:
affiliation: Ege University Faculty of Dentistry
name: Fulya Karaoglan
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.