Clinical and Radiographic Characteristics and Outcomes of Guided Apicoectomy With Retrograde Mineral Trioxide Aggregate Filling for Periapical Cysts

July 20, 2026 updated by: Can Tho University of Medicine and Pharmacy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Ho Chi Minh City, Vietnam
        • Department of Orthodontics, Ho Chi Minh City Dental Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Uncontrolled systemic diseases.
  • Coagulation disorders.
  • Uncontrolled diabetes mellitus.
  • Active malignancy receiving radiotherapy.
  • Severe cardiovascular disease contraindicating surgery.
  • Vertical root fracture.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Guided Apicoectomy With Retrograde Mineral Trioxide Aggregate Filling
Procedure: Guided Apicoectomy With Retrograde Mineral Trioxide Aggregate Filling
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Good Clinical Healing at 1 Week
Time Frame: 1 week after surgery
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.
1 week after surgery
Number of Participants With Good Clinical Healing at 3 Months
Time Frame: 3 months after surgery
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.
3 months after surgery
CBCT Bone Healing Score at 6 Months
Time Frame: 6 months after surgery
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.
6 months after surgery
Number of Participants With Postoperative Complications
Time Frame: 1 week, 3 months, and 6 months after surgery
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.
1 week, 3 months, and 6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Can Tho University of Medicine and Pharmacy

Investigators

  • Principal Investigator: Lam N Le, Faculty of Odonto-Stomatology, Can Tho University of Medicine and Pharmacy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2025

Primary Completion (Actual)

June 10, 2026

Study Completion (Actual)

June 10, 2026

Study Registration Dates

First Submitted

July 8, 2026

First Submitted That Met QC Criteria

July 20, 2026

First Posted (Actual)

July 24, 2026

Study Record Updates

Last Update Posted (Actual)

July 24, 2026

Last Update Submitted That Met QC Criteria

July 20, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LeNguyenLam_CTUMP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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