Assessment of the clinical outcome of the use of 3D printed guides for endodontic treatment
| ISRCTN | ISRCTN75277265 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75277265 |
- Submission date
- 20/01/2023
- Registration date
- 17/02/2023
- Last edited
- 07/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
The use of 3D-printed guides in dentistry offers a highly predictable outcome and lowers the risk of damage to the tooth. Up to five times less tooth substance is lost when drilling is guided compared with conventional treatment, allowing for minimally invasive treatment and a shorter treatment time. The aim of this study is to treat patients with the aid of a guiding system and assess the clinical outcome of guided endodontic treatment compared with freehand drilling (from a historical control group) in the context of quality control. Endodontics is a dental procedure used to treat infection at the centre of a tooth.
Who can participate?
Patients who need complex endodontic treatment in otherwise hopeless teeth
What does the study involve?
Endodontic treatment will be performed 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 drilling of an access cavity up to the root canal entrance. The clinical outcome of the patients will be compared to the outcome of patients from a historical control group, in which endodontic treatment was performed freehanded (without the assistance of a guiding system). The clinical outcome will be evaluated during treatment and the patients will be followed up at 6 months, 1 year and yearly after treatment, until healed.
What are the possible benefits and risks of participating?
Known potential benefits of the use of a guiding system are: a reduced likelihood of damage to the tooth, minimally invasive treatment, a high accuracy or likelihood of finding the target, reduced treatment time and increased safety. Potential risks are: damage to the root due to poor fitting of the guide or poor design, the persistence of bacteria (inside or outside of the canal), inadequate filling of the root canal and overextensions of root filling materials.
Where is the study run from?
UZ Leuven (Belgium)
When is the study starting and how long is expected to run for?
January 2018 to November 2023
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Andres Torres, andres.torres@kuleuven.be
Contact information
Principal Investigator
OMFS-IMPATH Research Group
St Raphael Hospital.
Kapucijnenvoer 33
Leuven
3000
Belgium
 ORCID ID |
0000-0001-8233-3025 |
|---|---|
| Phone | +32 (0)16 34 55 77 |
| andres.torres@kuleuven.be |
Study information
| Study design | Prospective non-randomized single-center study with an external (historical) control group |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Controlled clinical trial on the clinical outcome of guided endodontics vs freehand drilling for the treatment of pulp canal obliteration |
| Study objectives | Guided endodontics has a greater success rate than freehand drilling for the treatment of pulp canal obliteration |
| Ethics approval(s) | Approved 29/04/2022, Ethics Committee Research UZ/KU Leuven (Herestraat 49B, 3000 Leuven, Belgium; +32 (0)16 34 86 00; ec@uzleuven.be), ref: S64630 |
| Health condition(s) or problem(s) studied | Apical periodontitis in teeth presenting with pulp canal obliteration |
| Intervention | 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 drilling of an access cavity up to the root canal entrance. Every treatment will be performed under a dental microscope and adhering to the quality guidelines for endodontic treatment from the European Society of Endodontics. Such treatment can have a total duration of between 1 and 2 hours. Root canal treatment will be assessed at 6 months, 1 year and yearly as required, with a thorough clinical examination and acquisition of intraoral radiographs. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | The clinical outcome of the use of a guiding system (root canal found, not found or perforation of the root), assessed during treatment |
| Secondary outcome measures | 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 |
| Overall study start date | 01/01/2018 |
| Completion date | 01/11/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 60 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 24/05/2018 |
| Date of final enrolment | 23/09/2022 |
Locations
Countries of recruitment
- Belgium
Study participating centre
Leuven
3000
Belgium
Sponsor information
Hospital/treatment centre
c/o Prof. Reinhilde Jacobs
OMFS-IMPATH Research Group
Kapucijnenvoer 33
Leuven
3000
Belgium
| Phone | +32 (0)16 332452 |
|---|---|
| reinhilde.jacobs@kuleuven.be |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/07/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. All additional files will be provided as supplementary material upon publication in a high-end peer-reviewed journal. |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 06/11/2024 | 07/11/2024 | Yes | No |
Editorial Notes
07/11/2024: Publication reference added.
20/01/2023: Trial's existence confirmed by the Ethics Committee Research UZ/KU Leuven.
