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Completed

NCT Number: NCT05006209

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

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

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Key information

Conditions

Root Canal Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

One visit root canal treatment

Other

Other names: CHX

Two visit root canal treatment

Other

Other names: Calcium hydroxide

Primary outcomes

  1. 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..

  2. 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..

  3. 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..

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Aug 16, 2021
Registry last updated
Aug 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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