Impact of Treatment With ALVEOGYL in Patients With Post-extraction Dry Socket
NCT ID: NCT05536115
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2022-12-13
2024-12-31
Brief Summary
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ALVE study is a clinical investigation measuring Alveogyl performance and safety in patients with post-extraction dry socket.
The study takes place in India and in France where Alveogyl is already marketed, since 2010 in France and since 2014 in India .
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Study population
Study patients are patients with post-extraction dry socket.
Alveogyl
The patients will be treated by Alveogyl. Global treatment protocol (curettage, cleaning, local anaesthesia etc.) of the dry socket is at the discretion of the Investigator.
Alveogyl is used as an alveolar dressing. Placement of Alveogyl (about 0.2 g of paste) into the dental socket is done according to its instruction for use by a dental professional only.
Interventions
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Alveogyl
The patients will be treated by Alveogyl. Global treatment protocol (curettage, cleaning, local anaesthesia etc.) of the dry socket is at the discretion of the Investigator.
Alveogyl is used as an alveolar dressing. Placement of Alveogyl (about 0.2 g of paste) into the dental socket is done according to its instruction for use by a dental professional only.
Eligibility Criteria
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Inclusion Criteria
* Positive diagnosis of dry socket occurring after the extraction of a permanent tooth (mature or immature)
* Signed informed consent
* In France only :Patient affiliated to a Health Insurance Scheme ("sécurité sociale")
Exclusion Criteria
* Placement of Alveogyl done immediately after tooth extraction
* Multiple post-extraction dry sockets
* Patient treated with cervico-facial radiotherapy
* Immunodeficiency related to any diseases or current treatments
* Psychiatric patient or patient unable to assess his/her pain via the study Pain VAS
* Patient with history of hypersensitivity to one of the components
* Patient on post extraction of deciduous teeth
* Participation in another clinical investigation
5 Years
ALL
No
Sponsors
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SMO Clinical Research
UNKNOWN
QualityStat
UNKNOWN
Septodont
INDUSTRY
Responsible Party
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Principal Investigators
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Géraldine Lescaille, DDS, PhD
Role: STUDY_DIRECTOR
Odontology department - Pitié-Salpêtrière Hospital
Locations
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Hospital Henri-Mondor (AP-HP)
Créteil, , France
Odontology Department - Pitié-Salpêtrière Hospital
Paris, , France
Mallige Hospital
Bangalore, Karnataka, India
Smile Dental Care
Bangalore, Karnataka, India
Perfect Dental Studio
Bangalore, Karnataka, India
Cavalier Hospital
Bangalore, Karnataka, India
Smile Dental Clinic
Bangalore, Karnataka, India
The Dental Avenues
Bangalore, Karnataka, India
Sri Dental Multispeciality Dental Hospital
Hyderabad, , India
Vrisa Dental
Hyderabad, , India
Eledent International Digital Dentistry
Hyderabad, , India
Vardhaman Dental Care
Mumbai, , India
Mayur Dental Clinic
Mumbai, , India
Smile Gallery Dental Care Center
Pune, , India
Dr. Salke Dental & Implant Centre
Pune, , India
Sri Siddhartha Dental College
Tumakuru, , India
Countries
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Central Contacts
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Facility Contacts
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Francesca MANGIONE, MD, PhD
Role: primary
Géraldine Lescaille, DDS, PhD
Role: primary
Other Identifiers
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2022-A00208-35
Identifier Type: REGISTRY
Identifier Source: secondary_id
CI/MD/2022/66273
Identifier Type: REGISTRY
Identifier Source: secondary_id
ALVE 2022-01
Identifier Type: -
Identifier Source: org_study_id