Surgery Site FistulaNCT04499144
A Modified Approach for the Closure of Oral Sinus Communications
A study testing modified buccal flap and subepithelial connective palatal flap in people with Surgery Site Fistula, run by University of Siena at 1 site in Italy.
Trial summary
The aim of this study is to describe a modified surgical approach for the closure of oral sinus communications, using a buccal trapezoidal flap combined with a connective pedicle flap rotated from the palate Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgery Site Fistula
- What is being tested?
- modified buccal flap and subepithelial connective palatal flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteItaly
- Study dates
- 26 Jun 2020to 27 Jul 2020
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient with diagnosis of Oro-antral communication
- Patients with adequate radiographic status
- Patients who read and signed the informed consent
- Patients without periodontal disease
- Patients≥18
Who cannot join
- Pregnancy or breastfeeding patients
- Patients compliance and patients with mental disorders
- Patients with diabetes
- Patients with osteonecrosis
- Patients with head and neck cancer
Trial locations and contacts
1 site in 1 country.
Italy1 site
University of Siena- Department of medical biotechnologies
Siena, 53100
About this study
The aim of this study is to describe a modified surgical approach for the closure of oral sinus communications, using a buccal trapezoidal flap combined with a connective pedicle flap rotated from the palate
- Conditions
- Surgery Site Fistula
- Being tested
- modified buccal flap and subepithelial connective palatal flap
- Keywords
- Extraction, Oro-antral communication, Oro-antral 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.
modified buccal flap and subepithelial connective palatal flapProcedure or surgery
The connective flap was harvested from the deeper area of the palatal mucosa. Pedicle flap dimensions were reported using the periodontal probe. The flap was then rotated to cover the oro antral communication (OAC) area. The rotation could be in mesial or distal direction, related to OAC position and for the convenience of the donor site. The connective palatal flap was sutured to the buccal periostium using mattress sutures.
| Study group | Role | What they receive |
|---|---|---|
| modified buccal flap and subepithelial connective palatal flap | Experimental | Not described Receives: Procedure: modified buccal flap and subepithelial connective palatal flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Closure of the communication
Clinical observation
Measured: Day 30
Secondary outcomes (1)
Pain and discomfort
These parameters are described using VAS technique
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start26 Jun 2020
- Primary completion29 Jun 2020
- Study completion27 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery Site 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- case series of a new surgical design
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Siena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ralph Habib, University of Siena
- Investigators
- Ralph Habib, Dr., Principal investigator, University of Siena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499144
- Sponsor's protocol ID
- ODO002
- Status last verified
- Aug 2020
- First submitted
- 30 Jul 2020
- Last updated
- 10 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Modified Approach for the Closure of Oral Sinus Communications
- ClinicalTrials.gov ID
- NCT04499144
- Acronym / sponsor ID
- ODO002
- Conditions
- Surgery Site Fistula
- Keywords
- Extraction, Oro-antral communication, Oro-antral fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Study start
- 26 Jun 2020 (actual)
- Primary completion
- 29 Jun 2020 (actual)
- Study completion
- 27 Jul 2020 (actual)
- First posted
- 5 Aug 2020 (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 describe a modified surgical approach for the closure of oral sinus communications, using a buccal trapezoidal flap combined with a connective pedicle flap rotated from the palate
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- case series of a new surgical design
| Arm | Type | Receives |
|---|---|---|
| modified buccal flap and subepithelial connective palatal flap | Experimental | Procedure: modified buccal flap and subepithelial connective palatal flap |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with diagnosis of Oro-antral communication
- Patients with adequate radiographic status
- Patients who read and signed the informed consent
- Patients without periodontal disease
- Patients≥18
Key exclusion criteria (5 listed)
- Pregnancy or breastfeeding patients
- Patients compliance and patients with mental disorders
- Patients with diabetes
- Patients with osteonecrosis
- Patients with head and neck cancer
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 |
|---|---|---|
| modified buccal flap and subepithelial connective palatal flapThe connective flap was harvested from the deeper area of the palatal mucosa. Pedicle flap dimensions were reported using the periodontal probe. The flap was then rotated to cover the oro antral communication (OAC) area. The rotation could be in mesial or distal direction, related to OAC position and for the convenience of the donor site. The connective palatal flap was sutured to the buccal periostium using mattress sutures. | Procedure or surgery | modified buccal flap and subepithelial connective palatal flap |
Primary outcome
Closure of the communication
Time frame: Day 30
Clinical observation
1 secondary outcome
Pain and discomfort
Time frame: Day 30
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 10 Aug 2020.
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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.
Ralph Habib, Dr. principal investigator
University of Siena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modified buccal flap and subepithelial connective palatal flap in people with Surgery Site 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 5 inclusion and 5 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 10 Aug 2020. 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?
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?
Closure of the communication (time frame: Day 30). 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 10 Aug 2020.