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Clinical Trials/NCT05006209
NCT05006209CompletedNot Applicable

Comparison of One-visit Root Canal Treatment Using Chlorhexidine as a Final Irrigant and Conventional Two-visit Root Canal Treatment

Ege University0 sites100 target enrollmentStarted: June 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Primary Endpoint
Changes in the size and the PAI score of the periapical lesion

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

One visit root canal treatment with CHX

Active Comparator

The teeth were treated in one-visit (OV) root canal treatment. 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.

Intervention: One visit root canal treatment (Other)

Two visit root canal treatment with CH

Active Comparator

The teeth were treated in two visit (TV) root canal treatment. 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.

Intervention: Two visit root canal treatment (Other)

Outcomes

Primary Outcomes

Changes in the size and the PAI score of the periapical lesion

Time Frame: 48 months

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.

Clinical healing according to presence of clinical symptoms

Time Frame: 48 months

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..

Clinical healing according to presence of clinical symptoms

Time Frame: 12 months

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..

Clinical healing according to presence of clinical symptoms

Time Frame: 24 months

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..

Changes in the size and the PAI score of the periapical lesion

Time Frame: 12 months

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.

Changes in the size and the PAI score of the periapical lesion

Time Frame: 24 months

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Seniha Miçooğulları Kurt

Principle investigator, Asst. Assoc. Dr

Ege University

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