Oroantral FistulaCBSLNCT05910073
Efficacy Assessment of Lamina Curved Plate in Managing Oroantral Communication (OACs)
An observational study of Oroantral Fistula, run by Hôpital NOVO at 1 site in France.
Trial summary
The aim of this study is to assess the success rate, of using a Lamina Curved plate (Osteobiol® Laboratory) in the treatment of persistent OACs over 5mm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oroantral Fistula
- What is being tested?
- Lamina curved plate
- Type of treatment
- Medical device
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 16 May 2023to 29 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All major patients with persistent SBC greater than 5mm treated with an Osteobiol® Lamina curved plate.
Who may be able to join
- All patients with persistent OAC greater than 5mm treated with the use of an Osteobiol® Lamina curved plate
- Age ≥ 18 years
- Patients informed of the study and who did not object.
Who cannot join
- Follow-up less than 1 month after surgery
- Patient under guardianship
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Stomatology - Hôpital NOVO Pontoise site
Pontoise, 95300
About this study
The aim of this study is to assess the success rate, of using a Lamina Curved plate (Osteobiol® Laboratory) in the treatment of persistent OACs over 5mm.
Read the detailed description
Oroantral communication (OAC) is an abnormal opening that forms between the maxillary sinus and oral cavity. This communication can occur as a result of tooth extraction, maxillofacial surgery or dental infections. Microorganisms from the oral cavity can then colonise the maxillary sinuses, leading to infections. Prompt and effective management of a OAC is essential to prevent complications such as acute or chronic sinusitis, facial pain or inflammation. Closure is usually made surgically with a local flap such as Fat pad flap, palatal or vestibular flap or with natural or synthetic biomaterials.
However, OACs may persist even after attempted closure, and there is also a risk of facial nerve damage during the dissection of the Bichat's flap.
All these factors prompt the evaluation of surgical procedures employed in the treatment of OACs, including the use of the Lamina Curved biomaterial from Osteobiol®. This biomaterial comprises a decalcified flexible plate made of heterologous cortical bone. It serves to reconstruct the sinus floor and isolate the sinus from the oral cavity. The plate is secured using osteosynthesis screws and possesses the characteristic of being resorbable.
The objective of this study is to investigate the success rate, of utilizing the Lamina Curved plate (Osteobiol® Laboratory) and to provide surgeons with an additional reference technique for treating OACs larger than 5mm.
- Conditions
- Oroantral Fistula
- Being tested
- Lamina curved plate
- Keywords
- Oroantral Fistula, Lamina Curved plate, Oral Surgery, Chronic sinusitis
- Medical subject headings
- Oroantral Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lamina curved plateDevice
Use of a Lamina Curved plate (Osteobiol® Laboratory) in the treatment of OAC
| Study group | Role | What they receive |
|---|---|---|
| Lamina curved plate | Use of a Lamina Curved plate (Osteobiol® Laboratory) in the treatment of OAC Receives: Device: Lamina curved plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy assessment of Lamina Curved Plate in Managing Oroantral Communication
Number of patients with clinical closure of the OAC at D30 after the operation.
Measured: At the end of the study, an average of one month
Secondary outcomes (2)
Assessment of the complication rate
The complication rate of the technique will be evaluated by the number of patients having had at least one complication from D7 post-op to D30 post-op out of the number of patients included
Measured: At the end of the study, an average of one month
Assessment of the rate of suture disunion
The rate of suture disunion will be assessed by the number of patients with at least one suture disunion from postoperative day 7 to postoperative day 30 out of the number of patients included
Measured: At the end of the study, an average of one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start16 May 2023
- Primary completion29 Jun 2023
- Study completion29 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Nicolas Jaballah Magdeleine, Principal investigator, Hôpital NOVO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910073
- Sponsor's protocol ID
- CHRD0623
- Acronym
- CBSL
- Status last verified
- Jul 2023
- First submitted
- 9 Jun 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shahrour R, Shah P, Withana T, Jung J, Syed AZ. Oroantral communication, its causes, complications, treatments and radiographic features: A pictorial review. Imaging Sci Dent. 2021 Sep;51(3):307-311. doi: 10.5624/isd.20210035. Epub 2021 Jul 13.
PubMed 34621658Scott P, Fabbroni G, Mitchell DA. The buccal fat pad in the closure of oro-antral communications: an illustrated guide. Dent Update. 2004 Jul-Aug;31(6):363-4, 366. doi: 10.12968/denu.2004.31.6.363.
PubMed 15376721Lee JJ, Kok SH, Chang HH, Yang PJ, Hahn LJ, Kuo YS. Repair of oroantral communications in the third molar region by random palatal flap. Int J Oral Maxillofac Surg. 2002 Dec;31(6):677-80. doi: 10.1054/ijom.2001.0209.
PubMed 12521329Di Carlo R, Zara S, Ventrella A, Siani G, Da Ros T, Iezzi G, Cataldi A, Fontana A. Covalent Decoration of Cortical Membranes with Graphene Oxide as a Substrate for Dental Pulp Stem Cells. Nanomaterials (Basel). 2019 Apr 12;9(4):604. doi: 10.3390/nano9040604.
PubMed 31013705Caballe-Serrano J, Munar-Frau A, Delgado L, Perez R, Hernandez-Alfaro F. Physicochemical characterization of barrier membranes for bone regeneration. J Mech Behav Biomed Mater. 2019 Sep;97:13-20. doi: 10.1016/j.jmbbm.2019.04.053. Epub 2019 May 4.
PubMed 31085456Rossi R, Rancitelli D, Poli PP, Rasia Dal Polo M, Nannmark U, Maiorana C. The use of a collagenated porcine cortical lamina in the reconstruction of alveolar ridge defects. A clinical and histological study. Minerva Stomatol. 2016 Oct;65(5):257-68.
PubMed 27580650
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Assessment of Lamina Curved Plate in Managing Oroantral Communication (OACs)
- ClinicalTrials.gov ID
- NCT05910073
- Acronym / sponsor ID
- CBSL / CHRD0623
- Conditions
- Oroantral Fistula
- Keywords
- Oroantral Fistula, Lamina Curved plate, Oral Surgery, Chronic sinusitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 16 May 2023 (actual)
- Primary completion
- 29 Jun 2023 (actual)
- Study completion
- 29 Jun 2023 (actual)
- First posted
- 18 Jun 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.
The aim of this study is to assess the success rate, of using a Lamina Curved plate (Osteobiol® Laboratory) in the treatment of persistent OACs over 5mm.
Detailed description
Oroantral communication (OAC) is an abnormal opening that forms between the maxillary sinus and oral cavity. This communication can occur as a result of tooth extraction, maxillofacial surgery or dental infections. Microorganisms from the oral cavity can then colonise the maxillary sinuses, leading to infections. Prompt and effective management of a OAC is essential to prevent complications such as acute or chronic sinusitis, facial pain or inflammation. Closure is usually made surgically with a local flap such as Fat pad flap, palatal or vestibular flap or with natural or synthetic biomaterials.
However, OACs may persist even after attempted closure, and there is also a risk of facial nerve damage during the dissection of the Bichat's flap.
All these factors prompt the evaluation of surgical procedures employed in the treatment of OACs, including the use of the Lamina Curved biomaterial from Osteobiol®. This biomaterial comprises a decalcified flexible plate made of heterologous cortical bone. It serves to reconstruct the sinus floor and isolate the sinus from the oral cavity. The plate is secured using osteosynthesis screws and possesses the characteristic of being resorbable.
The objective of this study is to investigate the success rate, of utilizing the Lamina Curved plate (Osteobiol® Laboratory) and to provide surgeons with an additional reference technique for treating OACs larger than 5mm.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lamina curved plate | – | Device: Lamina curved plateUse of a Lamina Curved plate (Osteobiol® Laboratory) in the treatment of OAC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All major patients with persistent SBC greater than 5mm treated with an Osteobiol® Lamina curved plate.
Key inclusion criteria (3 listed)
- All patients with persistent OAC greater than 5mm treated with the use of an Osteobiol® Lamina curved plate
- Age ≥ 18 years
- Patients informed of the study and who did not object.
Key exclusion criteria (2 listed)
- Follow-up less than 1 month after surgery
- Patient under guardianship
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 |
|---|---|---|
| Lamina curved plateUse of a Lamina Curved plate (Osteobiol® Laboratory) in the treatment of OAC | Device | Lamina curved plate |
Primary outcome
Efficacy assessment of Lamina Curved Plate in Managing Oroantral Communication
Time frame: At the end of the study, an average of one month
Number of patients with clinical closure of the OAC at D30 after the operation.
2 secondary outcomes
Assessment of the complication rate
Time frame: At the end of the study, an average of one month
Assessment of the rate of suture disunion
Time frame: At the end of the study, an average of one month
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 19 Sep 2024.
- Background: PubMed 34621658Shahrour R, Shah P, Withana T, Jung J, Syed AZ. Oroantral communication, its causes, complications, treatments and radiographic features: A pictorial review. Imaging Sci Dent. 2021 Sep;51(3):307-311. doi: 10.5624/isd.20210035. Epub 2021 Jul 13.
- Background: PubMed 15376721Scott P, Fabbroni G, Mitchell DA. The buccal fat pad in the closure of oro-antral communications: an illustrated guide. Dent Update. 2004 Jul-Aug;31(6):363-4, 366. doi: 10.12968/denu.2004.31.6.363.
- Background: PubMed 12521329Lee JJ, Kok SH, Chang HH, Yang PJ, Hahn LJ, Kuo YS. Repair of oroantral communications in the third molar region by random palatal flap. Int J Oral Maxillofac Surg. 2002 Dec;31(6):677-80. doi: 10.1054/ijom.2001.0209.
- Background: PubMed 31013705Di Carlo R, Zara S, Ventrella A, Siani G, Da Ros T, Iezzi G, Cataldi A, Fontana A. Covalent Decoration of Cortical Membranes with Graphene Oxide as a Substrate for Dental Pulp Stem Cells. Nanomaterials (Basel). 2019 Apr 12;9(4):604. doi: 10.3390/nano9040604.
- Background: PubMed 31085456Caballe-Serrano J, Munar-Frau A, Delgado L, Perez R, Hernandez-Alfaro F. Physicochemical characterization of barrier membranes for bone regeneration. J Mech Behav Biomed Mater. 2019 Sep;97:13-20. doi: 10.1016/j.jmbbm.2019.04.053. Epub 2019 May 4.
- Background: PubMed 27580650Rossi R, Rancitelli D, Poli PP, Rasia Dal Polo M, Nannmark U, Maiorana C. The use of a collagenated porcine cortical lamina in the reconstruction of alveolar ridge defects. A clinical and histological study. Minerva Stomatol. 2016 Oct;65(5):257-68.
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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.
Dr Nicolas Jaballah Magdeleine principal investigator
Hôpital NOVO
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 Hôpital NOVO at 1 site in France.
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 3 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 19 Sep 2024. 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 France. 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?
Efficacy assessment of Lamina Curved Plate in Managing Oroantral Communication (time frame: At the end of the study, an average of one month). 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 NCT05910073, which also lists 6 linked publications.
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 19 Sep 2024.