NCT07724964

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2026

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 24, 2026

Completed
Last Updated

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

1.1 years

First QC Date

July 8, 2026

Last Update Submit

July 20, 2026

Conditions

Periapical Cyst

Keywords

ApicoectomyMineral Trioxide AggregateSurgical GuideCone Beam Computed Tomography

Outcome Measures

Primary Outcomes (1)

  • 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).

    6 months after surgery

Secondary Outcomes (4)

  • Number of Participants With Good Clinical Healing at 1 Week

    1 week after surgery

  • Number of Participants With Good Clinical Healing at 3 Months

    3 months after surgery

  • CBCT Bone Healing Score at 6 Months

    6 months after surgery

  • Number of Participants With Postoperative Complications

    1 week, 3 months, and 6 months after surgery

Study Arms (1)

Guided Apicoectomy With Retrograde Mineral Trioxide Aggregate Filling

EXPERIMENTAL
Procedure: Guided Apicoectomy With Retrograde Mineral Trioxide Aggregate Filling

Interventions

Guided Apicoectomy With Retrograde Mineral Trioxide Aggregate FillingPROCEDURE

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.

Guided Apicoectomy With Retrograde Mineral Trioxide Aggregate Filling

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthodontics, Ho Chi Minh City Dental Hospital

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

Radicular Cyst

Condition Hierarchy (Ancestors)

Periodontal CystOdontogenic CystsJaw CystsBone CystsCystsNeoplasmsJaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesPeriapical DiseasesPeriodontal DiseasesMouth Diseases

Study Officials

  • Lam N Le

    Faculty of Odonto-Stomatology, Can Tho University of Medicine and Pharmacy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2026

First Posted

July 24, 2026

Study Start

May 3, 2025

Primary Completion

June 10, 2026

Study Completion

June 10, 2026

Last Updated

July 24, 2026

Record last verified: 2026-07

Locations

VN(1)