Oroantral FistulaNCT06054204
Retrieval of Displaced Root in the Maxillary Sinus Via Lateral Bony Window Using the Piezoelectric Device
A study testing lateral bony window in people with Oroantral Fistula and Displaced Tooth, run by Tanta University at 1 site in Egypt.
Trial summary
Ten patients with displaced root in maxillary sinus will be included in this study. the root will be recieved via lateral bony window in maxillary sinus wall using peizoelectric device then the bony window will be repositioned in its place.The patients will be received, clinically and radiologically examined, managed… Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Oroantral Fistula, Displaced Tooth
- What is being tested?
- lateral bony window
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Sep 2022to 30 Sep 2023
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- root displaced in maxillary sinus absence of infection
Who cannot join
- • patients taking medications that affect bone healing
- patients underwent head and neck radiotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lecturer of Oral &Maxillofacial Surgery
Ten patients with displaced root in maxillary sinus will be included in this study. the root will be recieved via lateral bony window in maxillary sinus wall using peizoelectric device then the bony window will be repositioned in its place.The patients will be received, clinically and radiologically examined, managed and followed up at the Oral and Maxillofacial surgery Department, Faculty of Dentistry, Tanta University
Read the detailed description
Purpose: This study is designed to allow removal of displaced root from maxillary sinus with minimal surgical injury and simultaneous preservation of the integrity of the lateral wall of maxillary sinus by repositioning of osteotomized lateral bony window.
Materials \& Methods: Ten patients with displaced root in maxillary sinus will be included in this study.
surgical procedure: A full thickness flap will be elevated to expose the lateral wall of the sinus and a rectangular bony window will be done, then the sinus lining will be incised, the displaced root will be delivered, the bony window will be repositioned, and the flap will be sutured.
Preoperative evaluation: The patients will be evaluated clinically for presence of inflammation, infection or oroantral communication and radiographically using computed tomography (CT) scan to identify the position of the displaced root.
Postoperative evaluation: The patients will be evaluated clinically each week for one month regarding to healing, presence of infection, inflammation. Radiographically, immediate panoramic view to evaluate the position of bony window and four months later to evaluate bone healing CT scan.
- Conditions
- Oroantral Fistula, Displaced Tooth
- Being tested
- lateral bony window
- Keywords
- displaced root, maxillary sinus, lateral bony window, piezoelectric device
- Medical subject headings
- Oroantral Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lateral bony windowDevice
bony window will be made on lateral maxillary sinus wall using piezo-electric device after elevation of full thickness mucoperiosteal membrane
| Study group | Role | What they receive |
|---|---|---|
| lateral bony window in maxillary sinus | Experimental | a displaced root in maxillary sinus which will be removed through a rectangular bony window will be done on the lateral wall of sinus using piezo-electric device after elevation of a full thickness mucoperiosteal flap, then the bony window will be repositioned, and the flap will be sutured. Receives: Device: lateral bony window |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. degree of pain evaluated clinically
using visual analogue scale:0 represent no pain and 10 represents the highest level of pain
Measured: one-two weeks
soft tissue healing evaluated clinically
presence of dehiscence and exposure of bone or not
Measured: one- two week
the position of bony window evaluated radiographically
using panoramic view to evaluate the precise position of bony window
Measured: one week
bony window osteointegration and density evaluated radiographically
CT scan will be used using hounsfield units to evaluate density >1250 D1 850-1250 D2 350-850 D3 150-350 D4
Measured: four months
Secondary outcomes (1)
inflammation clinically
0 no inflammation 1-3 mild inflammation 4-7 moderate inflammation 8-10 sever inflammation 0 no inflammation 1-3 mild inflammation 4-7 moderate inflammation 8-10 sever inflammation 0 no inflammation 1-3 mild inflammation 4-7 moderate inflammation 8-10 sever inflammation
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start28 Sep 2022
- Primary completion21 Jul 2023
- Study completion30 Sep 2023
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.
- More trials run by Tanta UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single group assignment patients
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mona samy sheta, Tanta University
- Investigators
- mona s sheta, lecturer, Principal investigator, Tanta Universitymarwa t Ibrahim, lecturer, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054204
- Sponsor's protocol ID
- 2014
- Status last verified
- Nov 2023
- First submitted
- 19 Sep 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lecturer of Oral &Maxillofacial Surgery
- ClinicalTrials.gov ID
- NCT06054204
- Acronym / sponsor ID
- 2014
- Conditions
- Oroantral Fistula, Displaced Tooth
- Keywords
- displaced root, maxillary sinus, lateral bony window, piezoelectric device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 21 Jul 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 26 Sep 2023 (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.
Ten patients with displaced root in maxillary sinus will be included in this study. the root will be recieved via lateral bony window in maxillary sinus wall using peizoelectric device then the bony window will be repositioned in its place.The patients will be received, clinically and radiologically examined, managed and followed up at the Oral and Maxillofacial surgery Department, Faculty of Dentistry, Tanta University
Detailed description
Purpose: This study is designed to allow removal of displaced root from maxillary sinus with minimal surgical injury and simultaneous preservation of the integrity of the lateral wall of maxillary sinus by repositioning of osteotomized lateral bony window.
Materials \& Methods: Ten patients with displaced root in maxillary sinus will be included in this study.
surgical procedure: A full thickness flap will be elevated to expose the lateral wall of the sinus and a rectangular bony window will be done, then the sinus lining will be incised, the displaced root will be delivered, the bony window will be repositioned, and the flap will be sutured.
Preoperative evaluation: The patients will be evaluated clinically for presence of inflammation, infection or oroantral communication and radiographically using computed tomography (CT) scan to identify the position of the displaced root.
Postoperative evaluation: The patients will be evaluated clinically each week for one month regarding to healing, presence of infection, inflammation. Radiographically, immediate panoramic view to evaluate the position of bony window and four months later to evaluate bone healing CT scan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single group assignment patients
| Arm | Type | Receives |
|---|---|---|
| lateral bony window in maxillary sinus | Experimental | Device: lateral bony windowa displaced root in maxillary sinus which will be removed through a rectangular bony window will be done on the lateral wall of sinus using piezo-electric device after elevation of a full thickness mucoperiosteal flap, then the bony window will be repositioned, and the flap will be sutured. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- root displaced in maxillary sinus absence of infection
Key exclusion criteria (2 listed)
- • patients taking medications that affect bone healing
- patients underwent head and neck radiotherapy
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 |
|---|---|---|
| lateral bony windowbony window will be made on lateral maxillary sinus wall using piezo-electric device after elevation of full thickness mucoperiosteal membrane | Device | lateral bony window in maxillary sinus |
Primary outcome
1. degree of pain evaluated clinically
Time frame: one-two weeks
using visual analogue scale:0 represent no pain and 10 represents the highest level of pain
soft tissue healing evaluated clinically
Time frame: one- two week
presence of dehiscence and exposure of bone or not
the position of bony window evaluated radiographically
Time frame: one week
using panoramic view to evaluate the precise position of bony window
bony window osteointegration and density evaluated radiographically
Time frame: four months
CT scan will be used using hounsfield units to evaluate density >1250 D1 850-1250 D2 350-850 D3 150-350 D4
1 secondary outcome
inflammation clinically
Time frame: one week
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 2023.
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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.
mona s sheta, lecturer principal investigator
Tanta University
marwa t Ibrahim, lecturer principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lateral bony window in people with Oroantral Fistula and Displaced Tooth, run by Tanta University at 1 site in Egypt.
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 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 2023. 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 Egypt. 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?
1. degree of pain evaluated clinically (time frame: one-two weeks). The study lists 4 primary outcomes in all. 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 28 Nov 2023.