One and Two-visit Root Canal Retreatment

Not Applicable

Completed

• Conditions: Root Canal Infection
• Interventions: Other: One visit root canal retreatment; Other: Two visit root canal retreatment

• Registration Number: NCT05137613
• Lead Sponsor: Ege University

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.

Study Timeline

• Study Start: 2018-07-01
• Primary Completion: 2021-05-01
• Study Completion: 2021-08-01
• Status Verified: 2021-11
• Study First Submitted: 2021-11-17
• Study First Submitted QC: 2021-11-27
• Last Update Submitted: 2021-11-27
• Study First Posted: 2021-11-30
• Last Update Posted: 2021-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
One visit root canal retreatment	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	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.

Primary Outcome Measures

Name	Time	Method
The presence or absence of clinical symptoms in clinical examination	24 months	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.
The rate of radiographic healing of the periapical lesion.	24 months	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.

Secondary Outcome Measures

Name	Time	Method
The level of postoperative pain	12hours-24hours and 48 hours	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).

Trial Locations

Locations (1)

Ege University; 🇹🇷 Izmir, Turkey