Clinical And Radiographic Efficacy Of MTA Flow In Apicoectomy

The goal of this observational study is to learn about the short-term effects of MTA flow thick material in apicoectomy treatment. Participants are patients who take MTA flow to treat their apical lesion. The main question it aims to answer is:

Is MTA flow thick material effective for retrograde filling in patients who require apicoectomy for treating apical lesion? Participants already taking MTA flow as part of their regular dental care for apicoectomy will be followed-up treatment results in 6 months.

Study Overview

• Status: Completed
• Conditions: Clinical and Radiographic Success in 6 Months
• Intervention / Treatment: Drug: MTA flow material

Detailed Description

Quality assurance plan: all patients satisfy the inclusion criteria are invinted to participate the study. Radiography was performed using an standard kit. All surgical procedures were conducted by an experienced oral surgeon. Clinical signs, radiographic signs are independently evaluated by an endodontist and oral surgeon.

Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.

Source data verification: medical records adn paper report form. Data dictionary: clinical signs, swelling, pain, fistula, radiographic signs, success rate, rarefaction, periodontal space.

Standard Operating Procedures: none. Sample size assessment: none available. Plan for missing data: exclude from the participants, missing case will be reported in the results.

Statistical analysis plan: Data were collected and analysed using JASP software, version 0.19.3 (University of Amsterdam, Amsterdam, The Netherlands). Categorical variables are presented as absolute counts and percentages, whereas numerical variables are expressed as mean values with standard errors.

The Friedman test was used to compare differences in clinical symptoms and apical lesion sizes at baseline, 3 months, and 6 months. The Bonferroni post hoc test was used for pairwise comparisons between assessment points. The chi-square test was used to compare the differences in radiographic findings and overall success between 3-month and 6-month evaluations.

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• Vietnam
  • Ho Chi Minh City
    • Hanh Thong Ward, Ho Chi Minh City, Vietnam, 700000
      • Military Hospital 175

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Study population are patients who came to Dental Department of 175 Military hospital for apical lesions.

Description

Inclusion Criteria:

• age 18 years or older
• systemic health classified as I or II according to the American Society of Anesthesiologists (ASA) classification
• willingness to participate in the study
• failure of conventional or repeat endodontic treatment
• a periapical lesion with a diameter ≥ 5 mm

Exclusion Criteria:

• a crown-to-root ratio ≥ 1.0
• inability to comply with the follow-up protocol

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MTA flow; MTA flow group have this material for retrograde filling in apicoectomy.	Drug: MTA flow material; This group is used MTA flow material for retrograde filling in apicoectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical success	Clinical success is defined as absence of 4 clinical signs. These clinical signs included pain, swelling, and fistula at the etiologic tooth.	6 months
Radiographic success	To evaluate healing progression on periapical radiographs, images obtained at 3 and 6 months were compared with those taken at 7 days post-surgery. Radiographic success was evaluated according to the criteria proposed by Rud et al. (1972) and Molven et al. (1987).	6 months

Collaborators and Investigators

• Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
• Collaborators: 175 Military hospital
• Investigators: Principal Investigator: Loan-Chi Thi Bui, Military Hospital 175

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2021
• Primary Completion (Actual): October 21, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 28, 2025

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Apicoectomy; Retrograde filling; MTA Flow™; Mineral trioxide aggregate; Periapical healing
• Other Study ID Numbers: 493/HĐĐĐ-ĐHYD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD will be shared when other researchers ask for specific purpose.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes