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

August 7, 2021 updated by: Seniha Miçooğulları Kurt, Ege University

Comparison of One-visit Root Canal Treatment Using Chlorhexidine as a Final Irrigant and Conventional Two-visit Root Canal Treatment

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • with a non-contributory medical history,
  • mature molar teeth with periapical lesions,
  • diagnosed as asymptomatic apical periodontitis

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Other Names:
  • CHX
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
Other Names:
  • Calcium hydroxide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical healing according to presence of clinical symptoms
Time Frame: 12 months
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..
12 months
Clinical healing according to presence of clinical symptoms
Time Frame: 24 months
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..
24 months
Clinical healing according to presence of clinical symptoms
Time Frame: 48 months
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..
48 months
Changes in the size and the PAI score of the periapical lesion
Time Frame: 12 months
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.
12 months
Changes in the size and the PAI score of the periapical lesion
Time Frame: 24 months
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.
24 months
Changes in the size and the PAI score of the periapical lesion
Time Frame: 48 months
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.
48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ege University

Investigators

  • Principal Investigator: Seniha Miçooğulları Kurt, Ege University Faculty of Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

April 1, 2021

Study Registration Dates

First Submitted

July 24, 2021

First Submitted That Met QC Criteria

August 7, 2021

First Posted (Actual)

August 16, 2021

Study Record Updates

Last Update Posted (Actual)

August 16, 2021

Last Update Submitted That Met QC Criteria

August 7, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • one-visit root canal treatment

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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