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

NCT03336970 | Completed DMC

• 1 other identifier: Single visit study
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Root Canal Infection

Keywords

single visit root canal treatment, chlorhexidine

Outcome Measures

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).

  6,12 and 24 months

Secondary Outcomes (1)

• The level of postoperative pain

  24 hours and 48 hours

Study Arms (2)

Single visit root canal treatment

ACTIVE COMPARATOR

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

Multiple visit root canal treatment

ACTIVE COMPARATOR

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

EDTA OTHER

Multiple visit root canal treatment; Single visit root canal treatment

NaOCl OTHER

Multiple visit root canal treatment; Single visit root canal treatment

CHX OTHER

Single visit root canal treatment

Calcium hydroxide OTHER

Multiple visit root canal treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with a non-contributory medical history,
• mature maxillary anterior teeth with periapical lesions (\< 5 mm),
• diagnosed as asymptomatic apical periodontitis.

You may not qualify if:

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

Sponsors & Collaborators

• Mehmet Kemal Çalışkan: lead

Related Publications (6)

• 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.

  PMID: 22892729 BACKGROUND

• 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.

  PMID: 18291270 BACKGROUND

• 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.

  PMID: 20003932 BACKGROUND

• 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.

  PMID: 14600693 BACKGROUND

• 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.

  PMID: 12196219 BACKGROUND

• 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.

  PMID: 27142579 BACKGROUND

MeSH Terms

Interventions

Edetic Acid; Calcium Hydroxide

Intervention Hierarchy (Ancestors)

Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes

Study Officials

• Seniha Miçooğulları Kurt

  Ege University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

• Mehmet Kemal Çalışkan

  Ege University Faculty of Dentistry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.Dr.

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: November 8, 2017
• Study Start: January 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: June 1, 2014
• Last Updated: November 8, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share