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CompletedNCT05006209Updated Aug 16, 2021

One-visit Root Canal Treatment Using Chlorhexidine as a Final Irrigant

An interventional study of One visit root canal treatment and Two visit root canal treatment in Root Canal Infection, sponsored by Ege University. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-16.

Sponsored by Ege University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years 1 month after the study started (first participant enrolled Jun 2016, registered Jul 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Root Canal Infection

Keywords

  • chlorhexidine
  • one visit root canal treatment
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In context

Lead sponsor

Ege University is the lead sponsor of 365 studies on the registry; 46 are open to participants now.

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

Inclusion criteria

  • with a non-contributory medical history,
  • mature molar teeth with periapical lesions,
  • 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
100 participants (actual)

Study arms

  • Active comparator
    One visit root canal treatment with CHX

    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.

    Other: One visit root canal treatment

  • Active comparator
    Two visit root canal treatment with CH

    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.

    Other: Two visit root canal treatment

Interventions

  • OtherOne visit root canal treatment

    Also known as: CHX

  • OtherTwo visit root canal treatment

    Also known as: Calcium hydroxide

06

What researchers measure

Primary outcomes

  1. Clinical healing according to presence of clinical symptoms

    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..

    Time frame: 12 months

  2. Clinical healing according to presence of clinical symptoms

    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..

    Time frame: 24 months

  3. Clinical healing according to presence of clinical symptoms

    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..

    Time frame: 48 months

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

    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.

    Time frame: 12 months

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

    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.

    Time frame: 24 months

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

    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.

    Time frame: 48 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Micoogullari Kurt S, Caliskan MK. Efficacy of chlorhexidine as a final irrigant in one-visit root canal treatment: a prospective comparative study. Int Endod J. 2018 Oct;51(10):1069-1076. doi: 10.1111/iej.12931. Epub 2018 Apr 23. PubMed 29603299 ↗
  • 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 ↗
  • Siqueira JF Jr, Rocas IN. Optimising single-visit disinfection with supplementary approaches: a quest for predictability. Aust Endod J. 2011 Dec;37(3):92-8. doi: 10.1111/j.1747-4477.2011.00334.x. PubMed 22117714 ↗

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 Aug 16, 2021, 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
NCT05006209
Lead sponsor
Ege University
Responsible party
Seniha Miçooğulları Kurt (Principle investigator, Asst. Assoc. Dr, Ege University) — Principal investigator
First posted
Aug 16, 2021
Start date
Jun 1, 2016
Primary completion
Jan 1, 2021
Completion
Apr 1, 2021
Last update
Aug 16, 2021

Study contacts

Seniha Miçooğulları Kurt
principal investigator · 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 Aug 2021. You cannot join it, but the record below documents what was studied.

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