One and Two-visit Root Canal Retreatment

NCT05137613 | Completed

• 1 other identifier: Root canal retreatment
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

A hundred previously root canal treated asymptomatic single-rooted teeth with periapical lesions were treated in single versus multiple visit root canal retreatment. Half of the teeth were randomly assigned to the one-visit (OV) group. The other teeth were treated in two visits (TV). All patients were recalled and investigated clinically and radiographically for 24 months.

Conditions

Root Canal Infection

Outcome Measures

Primary Outcomes (2)

• The presence or absence of clinical symptoms in clinical examination

  All patients were called for follow up visits. The evaluation was performed by clinical examination. Clinical symptoms including presence of pain, tenderness to percussion and palpation, presence of sinus tract or swelling was detected and recorded as present or absent. If one of these symptoms recorded as present, it is considered as failure. If there is no symptom, it is considered as success.

  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. PAI 1 and 2 considered as healed, reduction in the PAI score was considered as healing and persistence or increased in the PAI score (PAI 4 or 5) was considered as failure.

  24 months

Secondary Outcomes (1)

• The level of postoperative pain

  12hours-24hours and 48 hours

Study Arms (2)

One visit root canal retreatment

ACTIVE COMPARATOR

The teeth were treated in one-visit (OV) root canal retreatment. 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 retreatment

Two visit root canal retreatment

ACTIVE COMPARATOR

The teeth were treated in two visit (TV) root canal retreatment. 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 retreatment

Interventions

One visit root canal retreatment OTHER

The teeth were treated in one-visit (OV) root canal retreatment. 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

One visit root canal retreatment

Two visit root canal retreatment OTHER

The teeth were treated in two visit (TV) root canal retreatment. 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.

Two visit root canal retreatment

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,
• single-rooted teeth with periapical lesions,
• previously root canal treated but no reduction in the lesion after the treatment
• diagnosed as asymptomatic apical periodontitis

You may not qualify if:

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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University

Izmir, Turkey (Türkiye)

Location

Related Publications (3)

• Eyuboglu TF, Olcay K, Ozcan M. A clinical study on single-visit root canal retreatments on consecutive 173 patients: frequency of periapical complications and clinical success rate. Clin Oral Investig. 2017 Jun;21(5):1761-1768. doi: 10.1007/s00784-016-1957-2. Epub 2016 Sep 22.

  PMID: 27660159 BACKGROUND

• He J, White RK, White CA, Schweitzer JL, Woodmansey KF. Clinical and Patient-centered Outcomes of Nonsurgical Root Canal Retreatment in First Molars Using Contemporary Techniques. J Endod. 2017 Feb;43(2):231-237. doi: 10.1016/j.joen.2016.10.029.

  PMID: 28132709 BACKGROUND

• Zhang MM, Fang GF, Chen XT, Liang YH. Four-year Outcome of Nonsurgical Root Canal Retreatment Using Cone-beam Computed Tomography: A Prospective Cohort Study. J Endod. 2021 Mar;47(3):382-390. doi: 10.1016/j.joen.2020.10.020. Epub 2020 Oct 29.

  PMID: 33130061 BACKGROUND

Study Officials

• Fulya Karaoglan

  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: Asst. Assoc. Dr

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: November 30, 2021
• Study Start: July 1, 2018
• Primary Completion: May 1, 2021
• Study Completion: August 1, 2021
• Last Updated: November 30, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)