NCT07005492

Brief Summary

The aim of this study is to evaluate the effects of pre-treatment and procedural factors on survival and success rates in teeth that underwent non-surgical root canal retreatment at Trakya University, Faculty of Dentistry between 2015-2017. Pre-treatment factors examined:

  • Age
  • Gender
  • Presence and size of periapical lesion
  • Quality of root canal obturation Factors examined during treatment:
  • Type of restoration
  • Status of restoration at recall The null hypothesis was that these factors have no effect on survival and success rate.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
408

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 5, 2025

Completed
Last Updated

June 5, 2025

Status Verified

January 1, 2025

Enrollment Period

Same day

First QC Date

January 13, 2025

Last Update Submit

June 4, 2025

Conditions

Keywords

root canal retreatmentnon-surgical root canal treatmentsurvivalsuccess

Outcome Measures

Primary Outcomes (2)

  • Survival rate

    Survival Rate: Survival was assessed whether the tooth was in the mouth or not. Survival was scored positive if the tooth was in the mouth, regardless of the health status of the tooth in the clinical and radiological examination at the follow-up appointment.

    78.47 ± 10.48 months after treatment

  • Success rate

    Success Rate: Scored as successful or unsuccessful according to the following effects according to the clinical and radiological examinations; restoration status, health of the periapical tissues, presence of swelling and/or the sinus tract. Success: The tooth had no clinical signs or symptoms, and the radiographs revealed complete resolution of periapical lesion Failure: The size of the periapical lesion was unchanged or increased or not completely healed, with or without clinical signs or symptoms

    78.47 +10.48 months

Study Arms (1)

Radiological and clinical examination

OTHER

The patients were examined radiologically and clinically.

Diagnostic Test: radiological and clinical examination

Interventions

Standard radiological (periapical radiography) and clinical (inspection, percussion, palpation tests etc.) examinations were performed.

Radiological and clinical examination

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years old at the time of treatment
  • Systemically healthy (ASA 1-2)
  • Acceptable obturation quality after treatment

You may not qualify if:

  • Precense of seperated instrument before or after treatment
  • Precense of perforation before or after treatment
  • Apical surgery before of before or after treatment
  • Immature root development
  • Two adjacent teeth which required root canal treatment or treatment
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trakya University, Faculty of Dentistry

Edirne, Merkez, 22061, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Physical Examination

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Burhan Can Çanakçş, Associate professor

    Trakya University, Faculty of Dentistry, Department of Endodontics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 13, 2025

First Posted

June 5, 2025

Study Start

June 1, 2023

Primary Completion

June 1, 2023

Study Completion

March 1, 2024

Last Updated

June 5, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations