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
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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
Sampling Method
Study Population
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?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
MTA flow
MTA flow group have this material for retrograde filling in apicoectomy.
|
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
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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
Collaborators
Investigators
- Principal Investigator: Loan-Chi Thi Bui, Military Hospital 175
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 493/HĐĐĐ-ĐHYD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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