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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05006209
Other study ID # one-visit root canal treatment
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2016
Est. completion date April 1, 2021

Study information

Verified date August 2021
Source Ege University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date April 1, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
One visit root canal treatment

Two visit root canal treatment


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ege University

References & Publications (3)

Miçoogullari Kurt S, Çaliskan 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. — View 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. — View Citation

Siqueira JF Jr, Rôças 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical healing according to presence of clinical symptoms All patients were called for follow up visits. The clinical healing was determined by examining clinical symptoms including presence of pain, tenderness to percussion and palpation, presence of sinus tract or swelling, and mobility. If one of these symptoms occurs, it is considered as failure.. 12 months
Primary Clinical healing according to presence of clinical symptoms All patients were called for follow up visits. The clinical healing was determined by examining clinical symptoms including presence of pain, tenderness to percussion and palpation, presence of sinus tract or swelling, and mobility.If one of these symptoms occurs, it is considered as failure.. 24 months
Primary Clinical healing according to presence of clinical symptoms All patients were called for follow up visits. The clinical healing was determined by examining clinical symptoms including presence of pain, tenderness to percussion and palpation, presence of sinus tract or swelling, and mobility.If one of these symptoms occurs, it is considered as failure.. 48 months
Primary Changes in the size and the PAI score of the periapical lesion 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. 12 months
Primary Changes in the size and the PAI score of the periapical lesion 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. 24 months
Primary Changes in the size and the PAI score of the periapical lesion 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. 48 months
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