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

NCT ID: NCT03336970

Last Updated: 2017-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-01

Study Completion Date

2014-06-01

Brief Summary

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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

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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).

Conditions

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Root Canal Infection

Keywords

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single visit root canal treatment, chlorhexidine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

EDTA

Intervention Type OTHER

NaOCl

Intervention Type OTHER

CHX

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

EDTA

Intervention Type OTHER

NaOCl

Intervention Type OTHER

Calcium hydroxide

Intervention Type OTHER

Interventions

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EDTA

Intervention Type OTHER

NaOCl

Intervention Type OTHER

CHX

Intervention Type OTHER

Calcium hydroxide

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mehmet Kemal Çalışkan

OTHER

Sponsor Role lead

Responsible Party

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Mehmet Kemal Çalışkan

Prof.Dr.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Seniha Miçooğulları Kurt

Role: PRINCIPAL_INVESTIGATOR

Ege University Faculty of Dentistry

Mehmet Kemal Çalışkan

Role: STUDY_DIRECTOR

Ege University Faculty of Dentistry

References

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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.

Reference Type BACKGROUND
PMID: 22892729 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18291270 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20003932 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14600693 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12196219 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27142579 (View on PubMed)

Other Identifiers

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Single visit study

Identifier Type: -

Identifier Source: org_study_id