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CompletedNCT03336970Updated Nov 8, 2017

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

An interventional study of EDTA and NaOCl in Root Canal Infection, sponsored by Mehmet Kemal Çalışkan. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-08.

Sponsored by Mehmet Kemal Çalışkan · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 years 10 months after the study started (first participant enrolled Jan 2011, registered Nov 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Root Canal Infection

Keywords

  • single visit root canal treatment, chlorhexidine
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In context

Lead sponsor

This is the only study on the registry with Mehmet Kemal Çalışkan as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • clinical symptoms, drainage,
  • more than 5 mm loss of periodontal attachment,
  • previous endodontic treatment,
  • non-restorable tooth.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
82 participants (actual)

Study arms

  • Active comparator
    Single visit root canal treatment

    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.

    Other: EDTA · Other: NaOCl · Other: CHX

  • Active comparator
    Multiple visit root canal treatment

    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.

    Other: EDTA · Other: NaOCl · Other: Calcium hydroxide

Interventions

  • OtherEDTA
  • OtherNaOCl
  • OtherCHX
  • OtherCalcium hydroxide
06

What researchers measure

Primary outcomes

  1. The rate of radiographic healing of the periapical lesion

    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).

    Time frame: 6,12 and 24 months

Secondary outcomes

  1. The level of postoperative pain

    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).

    Time frame: 24 hours and 48 hours

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Paredes-Vieyra J, Enriquez FJ. Success rate of single- versus two-visit root canal treatment of teeth with apical periodontitis: a randomized controlled trial. J Endod. 2012 Sep;38(9):1164-9. doi: 10.1016/j.joen.2012.05.021. Epub 2012 Jul 26. PubMed 22892729 ↗
  • Penesis VA, Fitzgerald PI, Fayad MI, Wenckus CS, BeGole EA, Johnson BR. Outcome of one-visit and two-visit endodontic treatment of necrotic teeth with apical periodontitis: a randomized controlled trial with one-year evaluation. J Endod. 2008 Mar;34(3):251-7. doi: 10.1016/j.joen.2007.12.015. PubMed 18291270 ↗
  • El Mubarak AH, Abu-bakr NH, Ibrahim YE. Postoperative pain in multiple-visit and single-visit root canal treatment. J Endod. 2010 Jan;36(1):36-9. doi: 10.1016/j.joen.2009.09.003. PubMed 20003932 ↗
  • Zamany A, Safavi K, Spangberg LS. The effect of chlorhexidine as an endodontic disinfectant. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2003 Nov;96(5):578-81. doi: 10.1016/s1079-2104(03)00168-9. PubMed 14600693 ↗
  • Peters LB, Wesselink PR. Periapical healing of endodontically treated teeth in one and two visits obturated in the presence or absence of detectable microorganisms. Int Endod J. 2002 Aug;35(8):660-7. doi: 10.1046/j.1365-2591.2002.00541.x. PubMed 12196219 ↗
  • Rocas IN, Provenzano JC, Neves MA, Siqueira JF Jr. Disinfecting Effects of Rotary Instrumentation with Either 2.5% Sodium Hypochlorite or 2% Chlorhexidine as the Main Irrigant: A Randomized Clinical Study. J Endod. 2016 Jun;42(6):943-7. doi: 10.1016/j.joen.2016.03.019. Epub 2016 Apr 30. PubMed 27142579 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03336970
Lead sponsor
Mehmet Kemal Çalışkan
Responsible party
Mehmet Kemal Çalışkan (Prof.Dr., Ege University) — Sponsor-investigator
First posted
Nov 8, 2017
Start date
Jan 1, 2011
Primary completion
Jan 1, 2014
Completion
Jun 1, 2014
Last update
Nov 8, 2017

Study contacts

Seniha Miçooğulları Kurt
principal investigator · Ege University Faculty of Dentistry
Mehmet Kemal Çalışkan
study director · Ege University Faculty of Dentistry

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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