Oroantral FistulaNCT05407493
Comparison of a Double-layered Technique With the Buccal Sliding Flap for Closure of Oroantral Communication
An observational study of Oroantral Fistula, run by University of Siena at 1 site in Italy.
Trial summary
The aim of this study is to compare the clinical results of combining a pedicle connective palatal flap with a trapezoid buccal flap with the standard buccal flap alone in the closure of oro-antral fistula (OAF), and the buccal flap combined with leukocyte and platelet rich fibrin. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Oroantral Fistula
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2018to Dec 2023
- 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 to 80 years
- All sexes
- Adult, Older adult
Study population: Eligible patients with a clinical diagnosis of oroantral fistula among those referring to the Dental department of Siena University Hospital
Who may be able to join
- Eligible population among those older than 18 y.o, systemically healthy, with a diagnosis of OAC (OroAntral Communication), or with a strong pre-extractive radiographic suspicion of potential OAC, and associated symptoms (varying among cheek pain with nasal obstruction, purulent rhinorrhea, foul odor, foul taste, headaches, anterior maxillary tenderness, and postnasal drip) .
Who cannot join
- received antibiotic therapy in the last 3 months ii) requiring anticoagulation therapy iii) had systemic diseases that could interfere with oral tissue healing process/bleeding iv) were using bisphosfonates v) were pregnant vi) had mental/physical disabilities vii) underwent radiation treatment to the head or neck region.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Dipartimento di Odontostomatologia
Siena, 53100
Nicola Baldini, 3382809460, baldini.nicola@gmail.com
About this study
The aim of this study is to compare the clinical results of combining a pedicle connective palatal flap with a trapezoid buccal flap with the standard buccal flap alone in the closure of oro-antral fistula (OAF), and the buccal flap combined with leukocyte and platelet rich fibrin.
- Conditions
- Oroantral Fistula
- Medical subject headings
- Oroantral Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Buccal flap | The buccal flap is slid over the fistula and sutured to the undermined palatal mucosa using horizontal mattress sutures. | |
| Double-layer | A combination between a buccal trapezoidal flap and a palatal connective pedicle flap. | |
| Buccal flap with L-PRF | A L-PRF plug is interposed between the fistula and the buccal sliding flap. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Closure success
Measured with probing and Valsalva test
Measured: One month after surgery
Secondary outcomes (1)
Patient reported Pain
Pain on a VAS scale
Measured: Each week for one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start1 Jan 2018
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oroantral FistulaStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Siena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Discepoli, University of Siena
- Investigators
- Nicola Discepoli, Study director, University of Siena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407493
- Sponsor's protocol ID
- ODO002, 26/06/2020
- Status last verified
- Jun 2022
- First submitted
- 1 Jun 2022
- Last updated
- 7 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Double-layered Technique With the Buccal Sliding Flap for Closure of Oroantral Communication
- ClinicalTrials.gov ID
- NCT05407493
- Acronym / sponsor ID
- ODO002, 26/06/2020
- Conditions
- Oroantral Fistula
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 7 Jun 2022 (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 aim of this study is to compare the clinical results of combining a pedicle connective palatal flap with a trapezoid buccal flap with the standard buccal flap alone in the closure of oro-antral fistula (OAF), and the buccal flap combined with leukocyte and platelet rich fibrin.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Buccal flap | – | –The buccal flap is slid over the fistula and sutured to the undermined palatal mucosa using horizontal mattress sutures. |
| Double-layer | – | –A combination between a buccal trapezoidal flap and a palatal connective pedicle flap. |
| Buccal flap with L-PRF | – | –A L-PRF plug is interposed between the fistula and the buccal sliding flap. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Eligible patients with a clinical diagnosis of oroantral fistula among those referring to the Dental department of Siena University Hospital
Key inclusion criteria (1 listed)
- Eligible population among those older than 18 y.o, systemically healthy, with a diagnosis of OAC (OroAntral Communication), or with a strong pre-extractive radiographic suspicion of potential OAC, and associated symptoms (varying among cheek pain with nasal obstruction, purulent rhinorrhea, foul odor, foul taste, headaches, anterior maxillary tenderness, and postnasal drip) .
Key exclusion criteria (1 listed)
- received antibiotic therapy in the last 3 months ii) requiring anticoagulation therapy iii) had systemic diseases that could interfere with oral tissue healing process/bleeding iv) were using bisphosfonates v) were pregnant vi) had mental/physical disabilities vii) underwent radiation treatment to the head or neck region.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Closure success
Time frame: One month after surgery
Measured with probing and Valsalva test
1 secondary outcome
Patient reported Pain
Time frame: Each week for one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
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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.
Nicola Discepoli study director
University of Siena
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 Oroantral Fistula, run by University of Siena at 1 site in Italy.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Jun 2022. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicola Baldini (00393382809460, baldini.nicola@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Closure success (time frame: One month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jun 2022.