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Clinical Trials/NCT05137613
NCT05137613
Completed
Not Applicable

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

Ege University1 site in 1 country100 target enrollmentJuly 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Root Canal Infection
Sponsor
Ege University
Enrollment
100
Locations
1
Primary Endpoint
The presence or absence of clinical symptoms in clinical examination
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2018
End Date
August 1, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Seniha Miçooğulları Kurt

Asst. Assoc. Dr

Ege University

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

Outcomes

Primary Outcomes

The presence or absence of clinical symptoms in clinical examination

Time Frame: 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.

Time Frame: 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 Outcomes

  • The level of postoperative pain(12hours-24hours and 48 hours)

Study Sites (1)

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