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

Root Canal Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03336970
• Other study ID #: Single visit study
• Status: Completed
• Phase: N/A
• First received: November 1, 2017
• Last updated: November 6, 2017
• Start date: January 1, 2011
• Est. completion date: June 1, 2014

Study information

• Verified date: November 2017
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: June 1, 2014
• Est. primary completion date: January 1, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Root Canal Infection

Intervention

Other:
• EDTA

• NaOCl

• CHX

• Calcium hydroxide

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mehmet Kemal Çaliskan

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Rôças 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. — View Citation

Zamany A, Safavi K, Spångberg LS. The effect of chlorhexidine as an endodontic disinfectant. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2003 Nov;96(5):578-81. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	24 hours and 48 hours