Periapical LesionsNCT07877168
Clinical and Radiographic Healing After Microscope-Assisted Endodontic Surgery
A study testing Microscope-Assisted Endodontic Surgery in people with Periapical Lesions, run by University of Medicine and Pharmacy at Ho Chi Minh City at 2 sites in Vietnam.
Trial summary
This study aimed to evaluate clinical and periapical radiographic healing following endodontic surgery using a surgical microscope. An uncontrolled longitudinal clinical intervention study was conducted in patients requiring endodontic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periapical Lesions
- What is being tested?
- Microscope-Assisted Endodontic Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesVietnam
- Study dates
- 28 Jul 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients classified as ASA I-II.
- Patients who agreed to participate and were willing to provide information and attend scheduled follow-up visits.
- Teeth indicated for endodontic surgery and considered preservable and restorable.
Who cannot join
- Patients with contraindications to oral surgery.
- Teeth with extensive destruction of dental and surrounding periodontal tissues, severe bone loss, or nonrestorable crowns.
- Periapical lesions with radiographic features suggestive of a tumor or malignancy.
Trial locations and contacts
2 sites in 1 country.
Vietnam2 sites
Center of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, 70000
Ho Chi Minh City Odonto-Stomatology Hospital
Ho Chi Minh City, 70000
About this study
Official title: Clinical And Periapical Radiographic Healing Following Endodontic Surgery Using A Surgical Microscope
This study aimed to evaluate clinical and periapical radiographic healing following endodontic surgery using a surgical microscope.
An uncontrolled longitudinal clinical intervention study was conducted in patients requiring endodontic surgery. All surgical procedures were performed using a surgical microscope, ultrasonic instruments, and mineral trioxide aggregate (MTA) root-end filling.
Postoperative healing was evaluated through clinical examinations and periapical radiographs at scheduled follow-up visits over a 3-month period. The study assessed clinical healing, radiographic healing, changes in periapical radiolucency, and overall treatment success.
- Conditions
- Periapical Lesions
- Being tested
- Microscope-Assisted Endodontic Surgery
- Keywords
- Endodontic Surgery, Surgical Microscope, Periapical Healing, Mineral Trioxide Aggregate (MTA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microscope-Assisted Endodontic SurgeryProcedure or surgery
Endodontic surgery was performed under a surgical microscope. The procedure included flap elevation, ultrasonic osteotomy, removal of periapical inflammatory tissue, resection of the apical 3 mm of the root, ultrasonic preparation of a 3-mm-deep root-end cavity, and root-end filling with MTA Repair HP. The surgical flap was repositioned and sutured.
| Study group | Role | What they receive |
|---|---|---|
| Microscope-Assisted Endodontic Surgery | Experimental | All participants underwent microscope-assisted endodontic surgery for teeth with periapical lesions and were followed for 3 months to assess clinical and radiographic healing. Receives: Procedure: Microscope-Assisted Endodontic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Healing
Clinical healing was assessed according to the criteria of Gutmann and Harrison (1994) and classified into three categories: complete, uncertain, and unsatisfactory healing.
Complete healing was defined as the absence of pain, infection, swelling, sinus tract, tenderness on palpation or percussion, tooth mobility, periodontal pocket communication with the root apex, and adverse effects on adjacent teeth.
Uncertain healing was defined by at least one of the following: vague intermittent symptoms, pressure or swelling sensation at the surgical site, mild pain on palpation, percussion, or chewing, or discomfort when applying pressure with the tongue.
Unsatisfactory healing was defined by at least one of the following: severe pain, infection, swelling, sinus tract, severe tenderness on palpation or percussion, tooth mobility, periodontal pocket communication with the root apex, or adverse effects on adjacent teeth.
Measured: 1 and 3 months after surgery
Radiographic Healing
Periapical radiographic healing was assessed using study-defined criteria based on Rud (1972) and Molven (1987). Three components were evaluated: the apical periodontal ligament space and lamina dura, periapical radiolucency, and bone regeneration.
Healing was classified as complete (restoration of a continuous lamina dura and complete bone regeneration), incomplete (reduced radiolucency with bone regeneration, irregular margins, and an asymmetric radiolucency separated from the periodontal ligament space), uncertain (reduced, round or semicircular radiolucency continuous with the periodontal ligament space), or unsatisfactory (unchanged or increased radiolucency).
Complete healing required all three components to be complete; incomplete healing required at least one incomplete component with all others complete; uncertain healing required at least one uncertain component and no unsatisfactory component; and unsatisfactory healing required at least one unsatisfactory component.
Measured: 1 and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start28 Jul 2024
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical LesionsStudies 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
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Le Huynh Thien An, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Huynh Thien An Le, PhD, Principal investigator, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877168
- Sponsor's protocol ID
- Endo-Microscope-2024
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical And Periapical Radiographic Healing Following Endodontic Surgery Using A Surgical Microscope
- ClinicalTrials.gov ID
- NCT07877168
- Acronym / sponsor ID
- Endo-Microscope-2024
- Conditions
- Periapical Lesions
- Keywords
- Endodontic Surgery, Surgical Microscope, Periapical Healing, Mineral Trioxide Aggregate (MTA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 28 Jul 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 16 Oct 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.
This study aimed to evaluate clinical and periapical radiographic healing following endodontic surgery using a surgical microscope.
An uncontrolled longitudinal clinical intervention study was conducted in patients requiring endodontic surgery. All surgical procedures were performed using a surgical microscope, ultrasonic instruments, and mineral trioxide aggregate (MTA) root-end filling.
Postoperative healing was evaluated through clinical examinations and periapical radiographs at scheduled follow-up visits over a 3-month period. The study assessed clinical healing, radiographic healing, changes in periapical radiolucency, and overall treatment success.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microscope-Assisted Endodontic Surgery | Experimental | Procedure: Microscope-Assisted Endodontic SurgeryAll participants underwent microscope-assisted endodontic surgery for teeth with periapical lesions and were followed for 3 months to assess clinical and radiographic healing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients classified as ASA I-II.
- Patients who agreed to participate and were willing to provide information and attend scheduled follow-up visits.
- Teeth indicated for endodontic surgery and considered preservable and restorable.
Key exclusion criteria (3 listed)
- Patients with contraindications to oral surgery.
- Teeth with extensive destruction of dental and surrounding periodontal tissues, severe bone loss, or nonrestorable crowns.
- Periapical lesions with radiographic features suggestive of a tumor or malignancy.
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 |
|---|---|---|
| Microscope-Assisted Endodontic SurgeryEndodontic surgery was performed under a surgical microscope. The procedure included flap elevation, ultrasonic osteotomy, removal of periapical inflammatory tissue, resection of the apical 3 mm of the root, ultrasonic preparation of a 3-mm-deep root-end cavity, and root-end filling with MTA Repair HP. The surgical flap was repositioned and sutured. | Procedure or surgery | Microscope-Assisted Endodontic Surgery |
Primary outcome
Clinical Healing
Time frame: 1 and 3 months after surgery
Clinical healing was assessed according to the criteria of Gutmann and Harrison (1994) and classified into three categories: complete, uncertain, and unsatisfactory healing. Complete healing was defined as the absence of pain, infection, swelling, sinus tract, tenderness on palpation or percussion, tooth mobility, periodontal pocket communication with the root apex, and adverse effects on adjacent teeth. Uncertain healing was defined by at least one of the following: vague intermittent symptoms, pressure or swelling sensation at the surgical site, mild pain on palpation, percussion, or chewing, or discomfort when applying pressure with the tongue. Unsatisfactory healing was defined by at least one of the following: severe pain, infection, swelling, sinus tract, severe tenderness on palpation or percussion, tooth mobility, periodontal pocket communication with the root apex, or adverse effects on adjacent teeth.
Radiographic Healing
Time frame: 1 and 3 months after surgery
Periapical radiographic healing was assessed using study-defined criteria based on Rud (1972) and Molven (1987). Three components were evaluated: the apical periodontal ligament space and lamina dura, periapical radiolucency, and bone regeneration. Healing was classified as complete (restoration of a continuous lamina dura and complete bone regeneration), incomplete (reduced radiolucency with bone regeneration, irregular margins, and an asymmetric radiolucency separated from the periodontal ligament space), uncertain (reduced, round or semicircular radiolucency continuous with the periodontal ligament space), or unsatisfactory (unchanged or increased radiolucency). Complete healing required all three components to be complete; incomplete healing required at least one incomplete component with all others complete; uncertain healing required at least one uncertain component and no unsatisfactory component; and unsatisfactory healing required at least one unsatisfactory component.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Periapical Lesions
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Diagnostic Performance of Ai vs Junior Dentists
Diagnosis
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A Retrospective Cohort Study on the Non-Surgical Treatment of Periapical Inflammatory Lesions With Vitapex Paste
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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. This study is not recruiting at the moment.
Huynh Thien An Le, PhD principal investigator
University of Medicine and Pharmacy at Ho Chi Minh City
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microscope-Assisted Endodontic Surgery in people with Periapical Lesions, run by University of Medicine and Pharmacy at Ho Chi Minh City at 2 sites 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Healing (time frame: 1 and 3 months after surgery). 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 27 Oct 2026.