NCT07254143

Clinical And Radiographic Efficacy Of MTA Flow In Apicoectomy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 16 (actual)
• Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Clinical and Radiographic Success in 6 Months

Interventions

Type	Name	Description
DRUG	MTA flow material	This group is used MTA flow material for retrograde filling in apicoectomy.

Timeline

• Start date: 2021-10-21
• Primary completion: 2022-10-21
• Completion: 2022-12-31
• First posted: 2025-11-28
• Last updated: 2025-11-28

Locations

1 site across 1 country: Vietnam

Regulatory

• FDA-regulated drug study