3D-Printed dental guide aims to boost precision in Root-End surgery
NCT ID NCT07734987
First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time
Summary
This trial tests whether a custom 3D-printed surgical guide can improve the accuracy of apicoectomy—a procedure to remove the tip of a tooth root after a failed root canal. Participants will have the guided surgery and then report pain and swelling at 1, 3, and 7 days. At 6 months, scans will check how well the bone has healed and how precise the surgery was compared to the original plan.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a 3D-printed static surgical guide and trephine bur
- What this could lead to
- If successful, this approach could make apicoectomy more precise, reducing pain and improving healing after failed root canal treatment.
- What could go wrong
- This is a small, early-stage trial with only 11 participants, so results may not apply widely. The procedure still involves surgery and carries risks like infection or nerve damage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 11 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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16 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patient is aged 16 years or older. 2. Patient possesses a healthy or stable systemic physical status classification (ASA I or II). 3. Presence of at least one permanent tooth displaying a distinct clinical indication for apical endodontic surgery. 4. The estimated post-resection crown-to-root ratio of the target tooth remains \<= 1. 5. The periapical radiolucency features a well-defined maximum radiographic dimension of \>= 5 mm on CBCT. 6. The target tooth has no history of previous surgical root-end resection procedures. 7. The lesion does not directly involve or impinge upon hazardous adjacent anatomical structures (e.g., the inferior alveolar nerve canal, the maxillary sinus floor, or the mental foramen). 8. The presence of at least three stable, non-mobile permanent teeth within the same dental arch to serve as reliable anchor units to support the surgical template. 9. Patient is fully capable and willing to provide signed written informed consent. Exclusion Criteria: 1. Women who are currently pregnant or breastfeeding. 2. History of known allergy or systemic hypersensitivity to amide local anesthetics, epinephrine co-agents, or any structural resins and bioceramic materials utilized in this protocol. 3. Extensive metal restorations, crowns, or massive fixed partial dentures adjacent to the target site that generate severe radiographic scattering artifacts, compromising CBCT measurement quality. 4. Target tooth displays clinical evidence of a vertical root fracture, non-restorable structural crown destruction, or advanced localized periodontitis. 5. Massive periapical pathology requiring a root-end resection length exceeding 3 mm, or necessitating excessive mechanical field widening beyond the template boundaries to achieve surgical curettage. 6. Inadequate stability, rocking, or poor fit of the printed surgical guide during the intraoral verification phase. 7. Patient demonstrates non-compliance or is unable to return for scheduled longitudinal follow-ups and imaging appointments.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Specialized Dental Clinic, Faculty of Odonto-Stomatology, University of Medicine and Pharmacy at Ho Chi Minh City.
RECRUITINGHo Chi Minh City, Vietnam
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