Clinical trial NCT05006209: One-visit Root Canal Treatment Using Chlorhexidine as a Final Irrigant
Official title: Comparison of One-visit Root Canal Treatment Using Chlorhexidine as a Final Irrigant and Conventional Two-visit Root Canal Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Root Canal Infection
Keywords: chlorhexidine
one visit root canal treatment
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2021-08-16
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 asymptomatic molar teeth with periapical lesions were treated in single versus multiple visit root canal treatment. Half of the teeth were randomly assigned to the one-visit (OV) group and received an additional final rinse with 2% CHX before obturation. The other teeth were treated in two visits (TV) with calcium hydroxide dressing. All patients were recalled and investigated clinically and radiographically for 48 months

Detailed description: The aim of the study was to evaluate the radiographic evidence of periapical healing in teeth with apical periodontitis treated in a single visit with an additional final irrigation using 2% chlorhexidine and to compare the results with conventional multiple-visit root canal treatment (RCT) with an intracanal calcium hydroxide dressing as a control group. 100 asymptomatic molar teeth with periapical lesions were treated using engine-driven nickel-titanium (NiTi) instrumentation 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 and received an additional final rinse with 2% chlorhexidine (CHX) before obturation. 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 48 months. Changes in apical bone density indicating radiographic healing were evaluated.

Eligibility criteria: Inclusion Criteria:

* with a non-contributory medical history,
* mature molar teeth with periapical lesions,
* diagnosed as asymptomatic apical periodontitis

Exclusion Criteria:

* clinical symptoms, drainage,
* more than 5 mm loss of periodontal attachment,
* previous endodontic treatment,
* non-restorable tooth

Primary outcomes:
measure: Clinical healing according to presence of clinical symptoms
timeFrame: 12 months
measure: Clinical healing according to presence of clinical symptoms
timeFrame: 24 months
measure: Clinical healing according to presence of clinical symptoms
timeFrame: 48 months
measure: Changes in the size and the PAI score of the periapical lesion
timeFrame: 12 months
measure: Changes in the size and the PAI score of the periapical lesion
timeFrame: 24 months
measure: Changes in the size and the PAI score of the periapical lesion
timeFrame: 48 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ege University Faculty of Dentistry
name: Seniha Miçooğulları Kurt
role: PRINCIPAL_INVESTIGATOR
References:
citation: Micoogullari Kurt S, Caliskan MK. Efficacy of chlorhexidine as a final irrigant in one-visit root canal treatment: a prospective comparative study. Int Endod J. 2018 Oct;51(10):1069-1076. doi: 10.1111/iej.12931. Epub 2018 Apr 23.
citation: Paredes-Vieyra J, Enriquez FJ. Success rate of single- versus two-visit root canal treatment of teeth with apical periodontitis: a randomized controlled trial. J Endod. 2012 Sep;38(9):1164-9. doi: 10.1016/j.joen.2012.05.021. Epub 2012 Jul 26.
citation: Siqueira JF Jr, Rocas IN. Optimising single-visit disinfection with supplementary approaches: a quest for predictability. Aust Endod J. 2011 Dec;37(3):92-8. doi: 10.1111/j.1747-4477.2011.00334.x.