Periapical PeriodontitisNCT07734987
Accuracy and Healing Outcomes of Endodontic Surgery Using a Static Surgical Guide.
A study testing 3D-Printed Static Surgical Guide and Trephine Bur and Ultrasonic Retrograde Preparation and Bioceramic Retrograde Obturation in people with Periapical Periodontitis and Periradicular Lesion, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
The goal of this clinical trial is to evaluate the surgical accuracy and healing outcomes of endodontic surgery performed with the assistance of a 3D-printed static surgical guide in patients requiring apicoectomy. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Periapical Periodontitis, Periradicular Lesion, Endodontic Treatment Failure
- What is being tested?
- 3D-Printed Static Surgical Guide and Trephine Bur and Ultrasonic Retrograde Preparation and Bioceramic Retrograde Obturation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jul 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient is aged 16 years or older.
- Patient possesses a healthy or stable systemic physical status classification (ASA I or II).
- Presence of at least one permanent tooth displaying a distinct clinical indication for apical endodontic surgery.
- The estimated post-resection crown-to-root ratio of the target tooth remains <= 1.
- The periapical radiolucency features a well-defined maximum radiographic dimension of >= 5 mm on CBCT.
- The target tooth has no history of previous surgical root-end resection procedures.
Show all 9Show fewer
- 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).
- 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.
- Patient is fully capable and willing to provide signed written informed consent.
Who cannot join
- Women who are currently pregnant or breastfeeding.
- 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.
- Extensive metal restorations, crowns, or massive fixed partial dentures adjacent to the target site that generate severe radiographic scattering artifacts, compromising CBCT measurement quality.
- Target tooth displays clinical evidence of a vertical root fracture, non-restorable structural crown destruction, or advanced localized periodontitis.
- 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.
- Inadequate stability, rocking, or poor fit of the printed surgical guide during the intraoral verification phase.
- Patient demonstrates non-compliance or is unable to return for scheduled longitudinal follow-ups and imaging appointments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Specialized Dental Clinic, Faculty of Odonto-Stomatology, University of Medicine and Pharmacy at Ho Chi Minh City.
Ho Chi Minh City
About this study
Official title: Evaluation of the Accuracy and Healing Outcomes of Endodontic Surgery Using a Static Surgical Guide: A Prospective Longitudinal Cohort Clinical Trial.
The goal of this clinical trial is to evaluate the surgical accuracy and healing outcomes of endodontic surgery performed with the assistance of a 3D-printed static surgical guide in patients requiring apicoectomy.
The main questions it aims to answer are:
Read more
- What is the level of positional and angular accuracy of the actual root-end resection compared to the virtual planning when utilizing a static surgical guide?
- What are the postoperative pain and swelling levels reported by patients at 1, 3, and 7 days after undergoing guided endodontic surgery?
- What are the clinical success rates and CBCT-based radiographic healing outcomes at 6 months postoperatively?
Participants will:
- Undergo a preoperative digital workflow combining CBCT data and intraoral surface scans to design a customized static surgical guide.
- Undergo targeted endodontic surgery where a 4.5-mm trephine bur is guided through the static template to perform the osteotomy and a 3-mm root-end resection in a single step.
- Receive retrograde root-end cavity preparation via ultrasonic tips and root-end filling using calcium aluminosilicate bioceramic paste (Well-Root PT).
- Complete self-evaluation forms regarding pain and swelling on postoperative days 1, 3, and 7.
- Return for follow-up examinations at 1 week (for suture removal) and at 6 months for definitive clinical evaluations, as well as follow-up multi-planar CBCT imaging to evaluate both periapical bone healing and surgical accuracy via superimposition with the baseline preoperative plan.
Read the detailed description
This prospective, single-arm, longitudinal clinical trial evaluates the accuracy and healing results of targeted endodontic surgery guided by 3D-printed static templates. The study aims to determine whether a fully digital workflow can standardize root-end resection, minimize bone removal, and provide favorable clinical outcomes.
Each eligible participant undergoes a standardized preoperative digital preparation. High-definition CBCT imaging data (DICOM format) and intraoral surface scan data (STL format) are acquired and imported into the Realguide software (version 5.0). After precise registration using three anatomical landmarks, the surgical path is planned. A virtual cylinder representing a 4.5-mm diameter trephine bur is positioned perpendicular to the root axis, calculated to achieve an exact 3-mm apicoectomy length. A teeth-supported static surgical guide with a 4.6-mm internal diameter sleeve and verification windows is then designed and fabricated using Stereolithography (SLA) 3D printing technology with biocompatible resin.
On the day of surgery, after administering local anesthesia (2% lidocaine with 1:100,000 epinephrine) and reflecting a full-thickness mucoperiosteal flap, the static surgical guide is securely positioned on the dental arch. Cortical plate osteotomy and root-end resection are executed in a single step through the guide sleeve using a 4.5-mm trephine bur at a speed of 800 rpm under continuous sterile saline irrigation. Following guide removal and periapical lesion debridement, a 3-mm deep retrograde cavity is prepared along the root canal axis using dedicated ultrasonic tips. The root end is then sealed with Well-Root PT bioceramic material, and the flap is secured using 5-0 nylon sutures. Postoperative medications including amoxicillin, ibuprofen, and paracetamol are prescribed uniformly.
Patient-centered outcomes (pain and swelling intensity) are self-recorded using a 6-point modified Visual Analog Scale (VAS) on days 1, 3, and 7 post-surgery. Sutures are removed at day 7. At the 6-month follow-up milestone, patients undergo comprehensive clinical evaluations based on the Gutmann \& Harrison (1994) criteria. Concurrently, a postoperative CBCT scan is performed using identical exposure parameters to quantify periapical lesion volume reduction and grade structural bone healing (cortical plate, resection plane, and peri-radicular space regeneration) according to the Azim (2021) criteria. The cumulative digital data sets are superimposed to calculate the linear distance (mm) and angular deviations (degrees) between the planned and actual surgical paths, thereby establishing the structural accuracy of the static guided technique.
- Conditions
- Periapical Periodontitis, Periradicular Lesion, Endodontic Treatment Failure, Postoperative Wound Healing
- Being tested
- 3D-Printed Static Surgical Guide and Trephine Bur, Ultrasonic Retrograde Preparation and Bioceramic Retrograde Obturation
- Keywords
- Static surgical guide, Endodontic surgery, Apicoectomy, Cone Beam Computed Tomography, Trephine bur, Well-Root PT, Structural accuracy, Bone healing outcomes
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-Printed Static Surgical Guide and Trephine BurDevice
A personalized dental template constructed from surgical guide clear resin via SLA technology, incorporating a guide sleeve to orient a 4.5-mm trephine bur for single-step cortical plate perforation and 3-mm root-end resection.
Ultrasonic Retrograde Preparation and Bioceramic Retrograde ObturationDevice
Preparation of a 3-mm deep root-end cavity using specialized ultrasonic tips driven by a piezo-ultrasonic surgical unit, followed by retrograde obturation with Well-Root PT calcium aluminosilicate bioceramic paste
| Study group | Role | What they receive |
|---|---|---|
| Static Guided Endodontic Surgery Group | Experimental | A single cohort of patients undergoing targeted endodontic surgery assisted by a custom-designed, 3D-printed teeth-supported static surgical guide. Receives: Device: 3D-Printed Static Surgical Guide and Trephine Bur; Device: Ultrasonic Retrograde Preparation and Bioceramic Retrograde Obturation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear Positional Deviation of Apicoectomy
The absolute vertical distance deviation (measured in millimeters) between the virtually planned root-end resection path and the actual resection plane achieved clinically. This measurement is quantified by superimposing the 6-month postoperative CBCT data onto the baseline preoperative planning model.
Measured: 6 months postoperatively
Angular Deviation of Apicoectomy
The angular difference (measured in degrees) between the long axis of the planned virtual surgical trajectory and the actual surgical track created by the trephine bur, measured across the structural plane containing the root axis
Measured: : 6 months postoperatively
Secondary outcomes (5)
Postoperative Pain Scores
Patient-reported pain intensity measured via a 6-point modified Visual Analog Scale (VAS) where 0 indicates no pain and 5 indicates severe, incapacitating pain requiring complete bed rest.
Measured: Postoperative days 1, 3, and 7
Postoperative Swelling Scores
Patient-reported tissue swelling measured via a 6-point modified VAS where 0 indicates no swelling and 5 indicates severe facial swelling accompanied by limited mouth opening (trismus).
Measured: Postoperative days 1, 3, and 7
Volumetric Change of Periapical Lesion
The quantitative volumetric reduction of the periapical radiolucency (calculated in cubic millimeters, mm³) determined by comparative three-dimensional rendering software on CBCT scans acquired at baseline and follow-up.
[Time Frame: Baseline and 6 months postoperatively]
Measured: Baseline and 6 months postoperatively
Clinical Healing Success Status
The proportion of cases achieving 'Complete Clinical Healing' defined according to the Gutmann \& Harrison (1994) criteria, requiring the total absence of pain, clinical tenderness to percussion or palpation, sinus tract formation, pathologic tooth mobility, or deep localized periodontal pockets.
Measured: 6 months postoperatively
Radiographic Healing Score (CBCT Evaluation)
The composite score (ranging from 0 to 6 points) derived by evaluating three distinct anatomical layers on multi-planar CBCT reconstructions: Cortical Plate remodeling (C), Resection Plane periodontal ligament space regeneration (R), and Peri-radicular lesion size and bone density (P), with each layer scored from 0 (no healing) to 2 (complete healing) according to the Azim (2021) criteria
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm, prospective clinical trial in which a single cohort of eligible participants consecutively receives targeted endodontic surgery assisted by a 3D-printed static guide, with each patient serving as their own baseline for healing evaluations, and actual surgical paths compared against virtual plans for accuracy assessments.
- Masking
- None (open label)
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nguyen Le Nguyen, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Son Hoang Le, DDS, PhD, Study director, Department of Oral Surgery, Faculty of Odonto-Stomatology, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734987
- Sponsor's protocol ID
- 2800/ĐHYD-HĐĐĐ
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Accuracy and Healing Outcomes of Endodontic Surgery Using a Static Surgical Guide: A Prospective Longitudinal Cohort Clinical Trial.
- ClinicalTrials.gov ID
- NCT07734987
- Acronym / sponsor ID
- 2800/ĐHYD-HĐĐĐ
- Conditions
- Periapical Periodontitis, Periradicular Lesion, Endodontic Treatment Failure, Postoperative Wound Healing
- Keywords
- Static surgical guide, Endodontic surgery, Apicoectomy, Cone Beam Computed Tomography, Trephine bur, Well-Root PT, Structural accuracy, Bone healing outcomes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the surgical accuracy and healing outcomes of endodontic surgery performed with the assistance of a 3D-printed static surgical guide in patients requiring apicoectomy.
The main questions it aims to answer are:
- What is the level of positional and angular accuracy of the actual root-end resection compared to the virtual planning when utilizing a static surgical guide?
- What are the postoperative pain and swelling levels reported by patients at 1, 3, and 7 days after undergoing guided endodontic surgery?
- What are the clinical success rates and CBCT-based radiographic healing outcomes at 6 months postoperatively?
Participants will:
- Undergo a preoperative digital workflow combining CBCT data and intraoral surface scans to design a customized static surgical guide.
- Undergo targeted endodontic surgery where a 4.5-mm trephine bur is guided through the static template to perform the osteotomy and a 3-mm root-end resection in a single step.
- Receive retrograde root-end cavity preparation via ultrasonic tips and root-end filling using calcium aluminosilicate bioceramic paste (Well-Root PT).
- Complete self-evaluation forms regarding pain and swelling on postoperative days 1, 3, and 7.
- Return for follow-up examinations at 1 week (for suture removal) and at 6 months for definitive clinical evaluations, as well as follow-up multi-planar CBCT imaging to evaluate both periapical bone healing and surgical accuracy via superimposition with the baseline preoperative plan.
Detailed description
This prospective, single-arm, longitudinal clinical trial evaluates the accuracy and healing results of targeted endodontic surgery guided by 3D-printed static templates. The study aims to determine whether a fully digital workflow can standardize root-end resection, minimize bone removal, and provide favorable clinical outcomes.
Each eligible participant undergoes a standardized preoperative digital preparation. High-definition CBCT imaging data (DICOM format) and intraoral surface scan data (STL format) are acquired and imported into the Realguide software (version 5.0). After precise registration using three anatomical landmarks, the surgical path is planned. A virtual cylinder representing a 4.5-mm diameter trephine bur is positioned perpendicular to the root axis, calculated to achieve an exact 3-mm apicoectomy length. A teeth-supported static surgical guide with a 4.6-mm internal diameter sleeve and verification windows is then designed and fabricated using Stereolithography (SLA) 3D printing technology with biocompatible resin.
On the day of surgery, after administering local anesthesia (2% lidocaine with 1:100,000 epinephrine) and reflecting a full-thickness mucoperiosteal flap, the static surgical guide is securely positioned on the dental arch. Cortical plate osteotomy and root-end resection are executed in a single step through the guide sleeve using a 4.5-mm trephine bur at a speed of 800 rpm under continuous sterile saline irrigation. Following guide removal and periapical lesion debridement, a 3-mm deep retrograde cavity is prepared along the root canal axis using dedicated ultrasonic tips. The root end is then sealed with Well-Root PT bioceramic material, and the flap is secured using 5-0 nylon sutures. Postoperative medications including amoxicillin, ibuprofen, and paracetamol are prescribed uniformly.
Patient-centered outcomes (pain and swelling intensity) are self-recorded using a 6-point modified Visual Analog Scale (VAS) on days 1, 3, and 7 post-surgery. Sutures are removed at day 7. At the 6-month follow-up milestone, patients undergo comprehensive clinical evaluations based on the Gutmann \& Harrison (1994) criteria. Concurrently, a postoperative CBCT scan is performed using identical exposure parameters to quantify periapical lesion volume reduction and grade structural bone healing (cortical plate, resection plane, and peri-radicular space regeneration) according to the Azim (2021) criteria. The cumulative digital data sets are superimposed to calculate the linear distance (mm) and angular deviations (degrees) between the planned and actual surgical paths, thereby establishing the structural accuracy of the static guided technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, prospective clinical trial in which a single cohort of eligible participants consecutively receives targeted endodontic surgery assisted by a 3D-printed static guide, with each patient serving as their own baseline for healing evaluations, and actual surgical paths compared against virtual plans for accuracy assessments.
| Arm | Type | Receives |
|---|---|---|
| Static Guided Endodontic Surgery Group | Experimental | Device: 3D-Printed Static Surgical Guide and Trephine Bur, Device: Ultrasonic Retrograde Preparation and Bioceramic Retrograde ObturationA single cohort of patients undergoing targeted endodontic surgery assisted by a custom-designed, 3D-printed teeth-supported static surgical guide. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Patient is aged 16 years or older.
- Patient possesses a healthy or stable systemic physical status classification (ASA I or II).
- Presence of at least one permanent tooth displaying a distinct clinical indication for apical endodontic surgery.
- The estimated post-resection crown-to-root ratio of the target tooth remains <= 1.
- The periapical radiolucency features a well-defined maximum radiographic dimension of >= 5 mm on CBCT.
Key exclusion criteria (7 listed)
- Women who are currently pregnant or breastfeeding.
- 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.
- Extensive metal restorations, crowns, or massive fixed partial dentures adjacent to the target site that generate severe radiographic scattering artifacts, compromising CBCT measurement quality.
- Target tooth displays clinical evidence of a vertical root fracture, non-restorable structural crown destruction, or advanced localized periodontitis.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D-Printed Static Surgical Guide and Trephine BurA personalized dental template constructed from surgical guide clear resin via SLA technology, incorporating a guide sleeve to orient a 4.5-mm trephine bur for single-step cortical plate perforation and 3-mm root-end resection. | Device | Static Guided Endodontic Surgery Group |
| Ultrasonic Retrograde Preparation and Bioceramic Retrograde ObturationPreparation of a 3-mm deep root-end cavity using specialized ultrasonic tips driven by a piezo-ultrasonic surgical unit, followed by retrograde obturation with Well-Root PT calcium aluminosilicate bioceramic paste | Device | Static Guided Endodontic Surgery Group |
Primary outcome
Linear Positional Deviation of Apicoectomy
Time frame: 6 months postoperatively
The absolute vertical distance deviation (measured in millimeters) between the virtually planned root-end resection path and the actual resection plane achieved clinically. This measurement is quantified by superimposing the 6-month postoperative CBCT data onto the baseline preoperative planning model.
Angular Deviation of Apicoectomy
Time frame: : 6 months postoperatively
The angular difference (measured in degrees) between the long axis of the planned virtual surgical trajectory and the actual surgical track created by the trephine bur, measured across the structural plane containing the root axis
5 secondary outcomes
Postoperative Pain Scores
Time frame: Postoperative days 1, 3, and 7
Postoperative Swelling Scores
Time frame: Postoperative days 1, 3, and 7
Volumetric Change of Periapical Lesion
Time frame: Baseline and 6 months postoperatively
Clinical Healing Success Status
Time frame: 6 months postoperatively
Radiographic Healing Score (CBCT Evaluation)
Time frame: 6 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Son Hoang Le, DDS, PhD study director
Department of Oral Surgery, Faculty of Odonto-Stomatology, University of Medicine and Pharmacy at Ho Chi Minh City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D-Printed Static Surgical Guide and Trephine Bur and Ultrasonic Retrograde Preparation and Bioceramic Retrograde Obturation in people with Periapical Periodontitis and Periradicular Lesion, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nguyen Le Nguyen, DDS (+84935998100, lenguyenyd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linear Positional Deviation of Apicoectomy (time frame: 6 months postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.