Periapical CystNCT07724964
Clinical and Radiographic Characteristics and Outcomes of Guided Apicoectomy With Retrograde Mineral Trioxide Aggregate Filling for Periapical Cysts
A study testing Guided Apicoectomy With Retrograde Mineral Trioxide Aggregate Filling in people with Periapical Cyst, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
Trial summary
Patients with periapical cysts associated with premolar teeth often require apical surgery when conventional endodontic treatment cannot resolve the lesion. Guided apicoectomy using a three-dimensional surgical guide may improve surgical accuracy while minimizing bone removal and reducing the risk of damage to… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periapical Cyst
- What is being tested?
- Guided Apicoectomy With Retrograde Mineral Trioxide Aggregate Filling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteVietnam
- Study dates
- 3 May 2025to 10 Jun 2026
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults diagnosed with a periapical cyst involving a premolar tooth.
- Diagnosis confirmed by clinical examination and CBCT.
- Histopathological confirmation of periapical cyst after surgery.
- Root canal treatment completed with acceptable obturation quality.
- Tooth considered restorable.
- No previous apicoectomy on the study tooth.
- Able to provide written informed consent.
Who cannot join
- Uncontrolled systemic diseases.
- Coagulation disorders.
- Uncontrolled diabetes mellitus.
- Active malignancy receiving radiotherapy.
- Severe cardiovascular disease contraindicating surgery.
- Vertical root fracture.
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- Grade IV tooth mobility.
- Allergy to local anesthetics or study materials.
- Previous surgery for recurrent periapical cyst at the study site.
- Inability to comply with follow-up schedule.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Department of Orthodontics, Ho Chi Minh City Dental Hospital
Ho Chi Minh City
About this study
Official title: Clinical and Radiographic Characteristics and Treatment Outcomes of Guided Apicoectomy With Retrograde Mineral Trioxide Aggregate Filling for Periapical Cysts in Premolar Teeth at Ho Chi Minh City Odonto-Stomatology Hospital
Patients with periapical cysts associated with premolar teeth often require apical surgery when conventional endodontic treatment cannot resolve the lesion. Guided apicoectomy using a three-dimensional surgical guide may improve surgical accuracy while minimizing bone removal and reducing the risk of damage to adjacent anatomical structures.
This prospective single-arm interventional study aims to evaluate the clinical and radiographic characteristics of premolar teeth with periapical cysts and assess the treatment outcomes of guided apicoectomy with retrograde Mineral Trioxide Aggregate (MTA) filling. Forty-two participants will be treated and followed for six months. Clinical healing and radiographic bone healing will be evaluated one week, three months, and six months after surgery.
Read the detailed description
Periapical cysts are common inflammatory lesions caused by pulpal infection and necrosis. Although conventional root canal treatment is effective in most cases, surgical intervention becomes necessary when persistent periapical lesions remain or true cysts develop.
Apicoectomy combined with retrograde filling using Mineral Trioxide Aggregate (MTA) has demonstrated high clinical success because of excellent sealing ability, biocompatibility, and stimulation of periapical tissue regeneration. Recently, computer-guided surgery integrating cone-beam computed tomography (CBCT), intraoral scanning, digital planning, and three-dimensional printing has improved surgical precision while minimizing unnecessary bone removal.
This prospective, single-center, single-arm interventional study will enroll 42 patients diagnosed with periapical cysts involving premolar teeth. Eligible participants will undergo guided apicoectomy, cyst enucleation, root-end cavity preparation, and retrograde filling with Mineral Trioxide Aggregate (MTA).
Clinical outcomes will be assessed one week, three months, and six months after surgery. Radiographic healing will be evaluated using cone-beam computed tomography (CBCT) at six months. The study aims to determine the effectiveness and safety of guided apicoectomy with MTA in treating premolar periapical cysts.
- Conditions
- Periapical Cyst
- Being tested
- Guided Apicoectomy With Retrograde Mineral Trioxide Aggregate Filling
- Keywords
- Apicoectomy, Mineral Trioxide Aggregate, Surgical Guide, Cone Beam Computed Tomography
- Medical subject headings
- Radicular Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Apicoectomy With Retrograde Mineral Trioxide Aggregate FillingProcedure or surgery
Patients undergo cone-beam computed tomography (CBCT) and intraoral scanning for digital treatment planning. A three-dimensional surgical guide is fabricated to accurately locate the root apex. Guided apicoectomy is performed with cyst enucleation, root-end resection, ultrasonic root-end cavity preparation, and retrograde filling using Mineral Trioxide Aggregate (MTA). Standard postoperative medications and follow-up examinations are provided.
| Study group | Role | What they receive |
|---|---|---|
| Guided Apicoectomy With Retrograde Mineral Trioxide Aggregate Filling | Experimental | Not described Receives: Procedure: Guided Apicoectomy With Retrograde Mineral Trioxide Aggregate Filling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Success Rate
The treatment success rate will be assessed 6 months after surgery based on predefined clinical and radiographic success criteria. Success is defined as the absence of clinical signs and symptoms together with evidence of bone healing on cone-beam computed tomography (CBCT).
Measured: 6 months after surgery
Secondary outcomes (4)
Number of Participants With Good Clinical Healing at 1 Week
Number of participants achieving good postoperative clinical healing according to the predefined postoperative evaluation criteria, including satisfactory wound healing without infection, wound dehiscence, excessive bleeding, or other clinically significant postoperative complications.
Measured: 1 week after surgery
Number of Participants With Good Clinical Healing at 3 Months
Number of participants achieving good clinical healing based on the predefined clinical evaluation criteria, including the absence of pain, swelling, sinus tract, tenderness to percussion or palpation, and other signs of persistent periapical disease.
Measured: 3 months after surgery
CBCT Bone Healing Score at 6 Months
Bone healing will be evaluated using cone-beam computed tomography (CBCT) according to the predefined CBCT healing criteria described in the study protocol. Bone healing will be summarized using the CBCT healing score.
Measured: 6 months after surgery
Number of Participants With Postoperative Complications
Number of participants experiencing postoperative complications, including surgical site infection, wound dehiscence, persistent swelling, persistent pain requiring additional treatment, prolonged bleeding, paresthesia, or any surgery-related adverse event.
Measured: 1 week, 3 months, and 6 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 posted24 Jul 2026
- Study start3 May 2025
- Primary completion10 Jun 2026
- Study completion10 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical CystStudies of the same condition, open and under way.
- 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Can Tho University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lam N Le, Principal investigator, Faculty of Odonto-Stomatology, Can Tho University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724964
- Sponsor's protocol ID
- LeNguyenLam_CTUMP
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Characteristics and Treatment Outcomes of Guided Apicoectomy With Retrograde Mineral Trioxide Aggregate Filling for Periapical Cysts in Premolar Teeth at Ho Chi Minh City Odonto-Stomatology Hospital
- ClinicalTrials.gov ID
- NCT07724964
- Acronym / sponsor ID
- LeNguyenLam_CTUMP
- Conditions
- Periapical Cyst
- Keywords
- Apicoectomy, Mineral Trioxide Aggregate, Surgical Guide, Cone Beam Computed Tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Can Tho University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 3 May 2025 (actual)
- Primary completion
- 10 Jun 2026 (actual)
- Study completion
- 10 Jun 2026 (actual)
- First posted
- 24 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.
Patients with periapical cysts associated with premolar teeth often require apical surgery when conventional endodontic treatment cannot resolve the lesion. Guided apicoectomy using a three-dimensional surgical guide may improve surgical accuracy while minimizing bone removal and reducing the risk of damage to adjacent anatomical structures.
This prospective single-arm interventional study aims to evaluate the clinical and radiographic characteristics of premolar teeth with periapical cysts and assess the treatment outcomes of guided apicoectomy with retrograde Mineral Trioxide Aggregate (MTA) filling. Forty-two participants will be treated and followed for six months. Clinical healing and radiographic bone healing will be evaluated one week, three months, and six months after surgery.
Detailed description
Periapical cysts are common inflammatory lesions caused by pulpal infection and necrosis. Although conventional root canal treatment is effective in most cases, surgical intervention becomes necessary when persistent periapical lesions remain or true cysts develop.
Apicoectomy combined with retrograde filling using Mineral Trioxide Aggregate (MTA) has demonstrated high clinical success because of excellent sealing ability, biocompatibility, and stimulation of periapical tissue regeneration. Recently, computer-guided surgery integrating cone-beam computed tomography (CBCT), intraoral scanning, digital planning, and three-dimensional printing has improved surgical precision while minimizing unnecessary bone removal.
This prospective, single-center, single-arm interventional study will enroll 42 patients diagnosed with periapical cysts involving premolar teeth. Eligible participants will undergo guided apicoectomy, cyst enucleation, root-end cavity preparation, and retrograde filling with Mineral Trioxide Aggregate (MTA).
Clinical outcomes will be assessed one week, three months, and six months after surgery. Radiographic healing will be evaluated using cone-beam computed tomography (CBCT) at six months. The study aims to determine the effectiveness and safety of guided apicoectomy with MTA in treating premolar periapical cysts.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Guided Apicoectomy With Retrograde Mineral Trioxide Aggregate Filling | Experimental | Procedure: Guided Apicoectomy With Retrograde Mineral Trioxide Aggregate Filling |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults diagnosed with a periapical cyst involving a premolar tooth.
- Diagnosis confirmed by clinical examination and CBCT.
- Histopathological confirmation of periapical cyst after surgery.
- Root canal treatment completed with acceptable obturation quality.
- Tooth considered restorable.
Key exclusion criteria (10 listed)
- Uncontrolled systemic diseases.
- Coagulation disorders.
- Uncontrolled diabetes mellitus.
- Active malignancy receiving radiotherapy.
- Severe cardiovascular disease contraindicating surgery.
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 |
|---|---|---|
| Guided Apicoectomy With Retrograde Mineral Trioxide Aggregate FillingPatients undergo cone-beam computed tomography (CBCT) and intraoral scanning for digital treatment planning. A three-dimensional surgical guide is fabricated to accurately locate the root apex. Guided apicoectomy is performed with cyst enucleation, root-end resection, ultrasonic root-end cavity preparation, and retrograde filling using Mineral Trioxide Aggregate (MTA). Standard postoperative medications and follow-up examinations are provided. | Procedure or surgery | Guided Apicoectomy With Retrograde Mineral Trioxide Aggregate Filling |
Primary outcome
Treatment Success Rate
Time frame: 6 months after surgery
The treatment success rate will be assessed 6 months after surgery based on predefined clinical and radiographic success criteria. Success is defined as the absence of clinical signs and symptoms together with evidence of bone healing on cone-beam computed tomography (CBCT).
4 secondary outcomes
Number of Participants With Good Clinical Healing at 1 Week
Time frame: 1 week after surgery
Number of Participants With Good Clinical Healing at 3 Months
Time frame: 3 months after surgery
CBCT Bone Healing Score at 6 Months
Time frame: 6 months after surgery
Number of Participants With Postoperative Complications
Time frame: 1 week, 3 months, and 6 months after surgery
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 24 Jul 2026.
Related trials for Periapical Cyst
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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.
Lam N Le principal investigator
Faculty of Odonto-Stomatology, Can Tho University of Medicine and Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Apicoectomy With Retrograde Mineral Trioxide Aggregate Filling in people with Periapical Cyst, run by Can Tho University of Medicine and Pharmacy 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 7 inclusion and 10 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 24 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?
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?
Treatment Success Rate (time frame: 6 months after surgery). 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 24 Jul 2026.