Skip to main content
OpenTrials
Completed

NCT Number: NCT07724964

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Periapical Cyst Bone Cysts Cysts Jaw Cysts Jaw Diseases Mouth Diseases Musculoskeletal Diseases Neoplasms Odontogenic Cysts Periapical Diseases Periodontal Cyst Periodontal Diseases Radicular Cyst Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthodontics, Ho Chi Minh City Dental Hospital

Ho Chi Minh City, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Guided Apicoectomy With Retrograde Mineral Trioxide Aggregate Filling

Procedure

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Can Tho University of Medicine and Pharmacy

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.