NCT05910073

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 16, 2023

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2023

Completed
Last Updated

September 19, 2024

Status Verified

July 1, 2023

Enrollment Period

1 month

First QC Date

June 9, 2023

Last Update Submit

September 3, 2024

Conditions

Oroantral Fistula

Keywords

Oroantral FistulaLamina Curved plateOral SurgeryChronic sinusitis

Outcome Measures

Primary Outcomes (1)

  • Efficacy assessment of Lamina Curved Plate in Managing Oroantral Communication

    Number of patients with clinical closure of the OAC at D30 after the operation.

    At the end of the study, an average of one month

Secondary Outcomes (2)

  • Assessment of the complication rate

    At the end of the study, an average of one month

  • Assessment of the rate of suture disunion

    At the end of the study, an average of one month

Study Arms (1)

Lamina curved plate

Use of a Lamina Curved plate (Osteobiol® Laboratory) in the treatment of OAC

Device: Lamina curved plate

Interventions

Lamina curved plateDEVICE

Use of a Lamina Curved plate (Osteobiol® Laboratory) in the treatment of OAC

Lamina curved plate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All major patients with persistent SBC greater than 5mm treated with an Osteobiol® Lamina curved plate.

You may qualify if:

  • 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.

You may not qualify if:

  • Follow-up less than 1 month after surgery
  • Patient under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Stomatology - Hôpital NOVO Pontoise site

Pontoise, 95300, France

Location

Related Publications (6)

  • 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.

    PMID: 34621658BACKGROUND

  • Scott 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.

    PMID: 15376721BACKGROUND

  • Lee 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.

    PMID: 12521329BACKGROUND

  • Di 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.

    PMID: 31013705BACKGROUND

  • Caballe-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.

    PMID: 31085456BACKGROUND

  • Rossi 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.

    PMID: 27580650BACKGROUND

MeSH Terms

Conditions

Oroantral Fistula

Condition Hierarchy (Ancestors)

Oral FistulaMouth DiseasesStomatognathic DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Dr Nicolas Jaballah Magdeleine

    Hôpital NOVO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2023

First Posted

June 18, 2023

Study Start

May 16, 2023

Primary Completion

June 29, 2023

Study Completion

June 29, 2023

Last Updated

September 19, 2024

Record last verified: 2023-07

Locations

FR(1)