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

NCT05006209 | Completed DMC

• 1 other identifier: one-visit root canal treatment
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Root Canal Infection

Keywords

chlorhexidine; one visit root canal treatment

Outcome Measures

Primary Outcomes (6)

• Clinical healing according to presence of clinical symptoms

  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

  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

  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

  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

  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

  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

Study Arms (2)

One visit root canal treatment with CHX

ACTIVE COMPARATOR

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

Two visit root canal treatment with CH

ACTIVE COMPARATOR

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

Interventions

One visit root canal treatment OTHER

Also known as: CHX

One visit root canal treatment with CHX

Two visit root canal treatment OTHER

Also known as: Calcium hydroxide

Two visit root canal treatment with CH

Eligibility Criteria

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

You may qualify if:

• with a non-contributory medical history,
• mature molar teeth with periapical lesions,
• 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

• Ege University: lead

Related Publications (3)

• Micoogullari Kurt S, Caliskan MK. Efficacy of chlorhexidine as a final irrigant in one-visit root canal treatment: a prospective comparative study. Int Endod J. 2018 Oct;51(10):1069-1076. doi: 10.1111/iej.12931. Epub 2018 Apr 23.

  PMID: 29603299 BACKGROUND

• 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

• Siqueira JF Jr, Rocas IN. Optimising single-visit disinfection with supplementary approaches: a quest for predictability. Aust Endod J. 2011 Dec;37(3):92-8. doi: 10.1111/j.1747-4477.2011.00334.x.

  PMID: 22117714 BACKGROUND

MeSH Terms

Interventions

Calcium Hydroxide

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes

Study Officials

• Seniha Miçooğulları Kurt

  Ege University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

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: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator, Asst. Assoc. Dr

Study Record Dates

• First Submitted: July 24, 2021
• First Posted: August 16, 2021
• Study Start: June 1, 2016
• Primary Completion: January 1, 2021
• Study Completion: April 1, 2021
• Last Updated: August 16, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share