Efficacy of Chlorhexidine as a Final Irrigant in Single-visit Root Canal Treatment

Not Applicable

Completed

• Conditions: Root Canal Infection
• Interventions: Other: EDTA; Other: NaOCl; Other: CHX; Other: Calcium hydroxide

• Registration Number: NCT03336970
• Lead Sponsor: Mehmet Kemal Çalışkan

Brief Summary

Ninety asymptomatic maxillary anterior teeth with periapical lesions were treated in single versus multiple visit root canal treatment. Half of the teeth were randomly assigned to the single-visit (SV) group and received an additional final rinse with 2% CHX before obturation. The other teeth were treated in multiple visits (MV) with calcium hydroxide dressing. All patients were recalled and investigated clinically and radiographically for 24 months.

Detailed Description

The aim of the study was to evaluate postoperative pain and 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. Ninety asymptomatic maxillary anterior teeth with periapical lesions were treated by a single operator using the step-back technique with manual instrumentation with 2.5% sodium hypochlorite (NaOCl) and 5% ethylenediaminetetraacetic acid (EDTA) as irrigants. Half of the teeth were randomly assigned to the single-visit (SV) group and received an additional final rinse with 2% chlorhexidine (CHX) before obturation. The other teeth were treated in multiple visits (MV), 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. Postoperative pain at 24-48 hours and changes in apical bone density indicating radiographic healing were evaluated statistically using the Mann-Whitney U-test followed by the Friedman and the Wilcoxon tests (α=.05).

Study Timeline

• Study Start: 2011-01-01
• Primary Completion: 2014-01-01
• Study Completion: 2014-06-01
• Status Verified: 2017-11
• Study First Submitted: 2017-11-01
• Study First Submitted QC: 2017-11-06
• Last Update Submitted: 2017-11-06
• Study First Posted: 2017-11-08
• Last Update Posted: 2017-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• patients with a non-contributory medical history,
• mature maxillary anterior teeth with periapical lesions (< 5 mm),
• 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single visit root canal treatment	EDTA	The teeth were treated in single-visit (SV) 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.
Single visit root canal treatment	NaOCl	The teeth were treated in single-visit (SV) 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.
Single visit root canal treatment	CHX	The teeth were treated in single-visit (SV) 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.
Multiple visit root canal treatment	Calcium hydroxide	The teeth were treated in multiple visit (MV) root canal treatment. After completion of root canal instrumentation, calcium hydroxide 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.
Multiple visit root canal treatment	EDTA	The teeth were treated in multiple visit (MV) root canal treatment. After completion of root canal instrumentation, calcium hydroxide 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.
Multiple visit root canal treatment	NaOCl	The teeth were treated in multiple visit (MV) root canal treatment. After completion of root canal instrumentation, calcium hydroxide 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 rate of radiographic healing of the periapical lesion	6,12 and 24 months	Follow-up visits were performed after 6, 12 and 24 months for all patients in order to evaluate radiographic status. Changes in apical bone density indicating radiographic healing was assessed by the periapical index (PAI).

Secondary Outcome Measures

Name	Time	Method
The level of postoperative pain	24 hours and 48 hours	Postoperative pain after 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).