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OpenTrials
Completed

NCT Number: NCT03336970

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EDTA

Other

NaOCl

Other

CHX

Other

Calcium hydroxide

Other

Primary outcomes

  1. The rate of radiographic healing of the periapical lesion

    Time frame: 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 outcomes

  1. The level of postoperative pain

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Mehmet Kemal Çalışkan

Other

Registry information

Official study title

Efficacy of Chlorhexidine as a Final Irrigant in Single-visit Root Canal Treatment: A Prospective Comparative Study

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 8, 2017
Registry last updated
Nov 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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