Clinical and Radiographic Success in 6 MonthsNCT07254143
Clinical And Radiographic Efficacy Of MTA Flow In Apicoectomy
An observational study of Clinical and Radiographic Success in 6 Months, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical and Radiographic Success in 6 Months
- What is being tested?
- MTA flow material
- How many people
- 16 participants
- Where
- 1 siteVietnam
- Study dates
- 21 Oct 2021to 31 Dec 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population are patients who came to Dental Department of 175 Military hospital for apical lesions.
Who may be able to join
- 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
Who cannot join
- a crown-to-root ratio ≥ 1.0
- inability to comply with the follow-up protocol
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- MTA flow material
- Keywords
- Apicoectomy; Retrograde filling; MTA Flow™; Mineral trioxide aggregate; Periapical healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTA flow materialDrug
This group is used MTA flow material for retrograde filling in apicoectomy.
| Study group | Role | What they receive |
|---|---|---|
| MTA flow | MTA flow group have this material for retrograde filling in apicoectomy. Receives: Drug: MTA flow material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success
Clinical success is defined as absence of 4 clinical signs. These clinical signs included pain, swelling, and fistula at the etiologic tooth.
Measured: 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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start21 Oct 2021
- Primary completion21 Oct 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clinical and Radiographic Success in 6 MonthsStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- 175 Military hospital
- Responsible party
- Principal investigator, Son Hoang Le, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Loan-Chi Thi Bui, Principal investigator, Military Hospital 175
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254143
- Sponsor's protocol ID
- 493/HĐĐĐ-ĐHYD
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be shared when other researchers ask for specific purpose.
Publications
Bui LT, Le SH, Huynh HTH, Nguyen BT. Clinical and radiographic evaluation of MTA Flow thick as a retrograde filling material in apicoectomy: a preliminary study. BMC Res Notes. 2026 Sep 29;19(1):365. doi: 10.1186/s13104-026-07911-6.
PubMed 42806398
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical And Radiographic Efficacy Of MTA Flow In Apicoectomy
- ClinicalTrials.gov ID
- NCT07254143
- Acronym / sponsor ID
- 493/HĐĐĐ-ĐHYD
- Keywords
- Apicoectomy; Retrograde filling; MTA Flow™; Mineral trioxide aggregate; Periapical healing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Collaborators
- 175 Military hospital
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 21 Oct 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MTA flow | – | Drug: MTA flow materialMTA flow group have this material for retrograde filling in apicoectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population are patients who came to Dental Department of 175 Military hospital for apical lesions.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- a crown-to-root ratio ≥ 1.0
- inability to comply with the follow-up protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MTA flow materialThis group is used MTA flow material for retrograde filling in apicoectomy. | Drug | MTA flow |
Primary outcome
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Derived from this study: PubMed 42806398Bui LT, Le SH, Huynh HTH, Nguyen BT. Clinical and radiographic evaluation of MTA Flow thick as a retrograde filling material in apicoectomy: a preliminary study. BMC Res Notes. 2026 Sep 29;19(1):365. doi: 10.1186/s13104-026-07911-6.
- Individual participant dataSharing planned: Undecided. IPD will be shared when other researchers ask for specific purpose.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loan-Chi Thi Bui principal investigator
Military Hospital 175
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinical and Radiographic Success in 6 Months, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07254143, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.