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Assessment of the clinical outcome of the use of 3D printed guides for endodontic treatment

Controlled clinical trial on the clinical outcome of guided endodontics vs freehand drilling for the treatment of pulp canal obliteration

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN75277265
Enrollment
60
Registered
2023-02-17
Start date
2018-05-24
Completion date
Unknown
Last updated
2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apical periodontitis in teeth presenting with pulp canal obliteration Oral Health Chronic apical periodontitis

Interventions

Endodontic treatment will be performed in every patient with the aid of a 3D printed guide that will fit snugly on the patient’s teeth and will help to guide the bur through a metallic sleeve for the

Sponsors

St Raphael Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Male or female patients attending the Endodontic Department at the University Hospitals of Leuven, Campus Sint-Rafaël with the need for complex endodontic treatment. To classify as complex, the tooth may present one or more of the following: 1. Pulp canal obliteration (PCO) or canal not seen on a periapical radiograph 2. Anatomical deviations (dens in dente or other) where localizing the root canal may be challenging or compromise the tooth by free-handed treatment 3. Present an obstruction in the canal 4. Resorption, either internal or external 5. Root perforation 6. Presenting symptoms and/or radiographic signs of apical periodontitis (AP)

Exclusion criteria

Exclusion criteria: 1. Patient unwilling or unable to comply with the endodontic treatment and follow-up periods 2. Tooth in need of extraction or with an unfavorable prognosis

Design outcomes

Primary

MeasureTime frame
The clinical outcome of the use of a guiding system (root canal found, not found or perforation of the root), assessed during treatment

Secondary

MeasureTime frame
1. Precision measurements (i.e. deviation of the access cavity) will be recorded by acquiring a digital intraoral impression during treatment. This second impression is then registered with the planning and the exact deviation of the drilling path can be calculated using 3D software. The deviation at the entry point and end of cavity will be measured and recorded in millimeters. The drilling angulation in comparison to the planned trajectory will be measured and recorded in degrees. 2. Outcome of root canal treatment assessed at 6 months, 1 year and yearly as required with a thorough clinical examination and acquisition of intraoral radiographs. The following findings indicate a favorable outcome: absence of pain, swelling and other symptoms, no sinus tract, no loss of function and radiological evidence of a normal periodontal ligament space around the root. 3. Tooth survival, defined as the continuous function of the tooth in the mouth with an absence of clinical symptoms, but regardless of their radiographic periapical status, measured together with the planned follow-up at 6 months, 1 year and yearly until healing of the case

Countries

Belgium

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 5, 2026