One and Two-visit Root Canal Retreatment

Root Canal Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05137613
• Other study ID #: Root canal retreatment
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: August 1, 2021

Study information

• Verified date: November 2021
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 1, 2021
• Est. primary completion date: May 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,
• 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

Related Conditions & MeSH terms

• Root Canal Infection

Intervention

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
• 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.

Locations

Country	Name	City	State
Turkey	Ege University	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Eyuboglu TF, Olcay K, Özcan 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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