Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06539299
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Socket Preservation - A Randomized Clinical Implementation in a Student Setting
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Socket Preservation - How Successful is the Method for Inexperienced Practitioners A Randomized Clinical Implementation in a Student Setting
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Preserving the ridge dimension after tooth extraction aims to avoid the need for bone augmentation procedures before implant placement This study aims to show that socket preservation procedure is a safe easy and predictable method that stabilizes the bone situation when late implantation is planned
Detailed Description:
Preserving the ridge dimension after tooth extraction aims to avoid the need for further augmentative procedures before implant placement Immediately after the extraction a bone replacement material is inserted into the empty socket and covered with a membrane to protect it to maintain or even improve alveolar bone dimension But how promising is it if such an operation is carried out by an inexperienced practitioner The aim is to show that socket preservation is a predictable promising and an easy-to-implement method that creates a better initial bone situation for later implant placement The execution by a student is intended as a simulation of a inexperienced practitioners
Design
A total of 51 patients with the need of extraction of a single-rooted lower jaw tooth 35-45 will be recruited from the dental clinic of the Sigmund Freud Private University Written consent will be given before enrollment in the study All subjects will receive a professional cleaning and hygiene instruction before the start of the study The extracted tooth will be replaced by a dental implant after six months of healing
The patients are divided into three groups 17 participants each
Group 1 serves as a control group no ridge prophylactic measures are taken after tooth extraction
In groups 2 and 3 after the extraction a socket preservation is made with a companys bone replacement material and a membrane Geistlich BioOss Collagen Mucograft Seal by a student Group 2 or investigator doctor 3 The allocation to the respective group is carried out randomly using a random generator The entire treatment takes place in all groups under the supervision of one study doctor
Dimensional changes of the bone will be measured after the extraction and after 6 month using CBCT Scans
Design
A total of 51 patients with the need of extraction of a single-rooted lower jaw tooth 35-45 will be recruited from the dental clinic of the Sigmund Freud Private University Written consent will be given before enrollment in the study All subjects will receive a professional cleaning and hygiene instruction before the start of the study The extracted tooth will be replaced by a dental implant after six months of healing
The patients are divided into three groups 17 participants each
Group 1 serves as a control group no ridge prophylactic measures are taken after tooth extraction
In groups 2 and 3 after the extraction a socket preservation is made with a companys bone replacement material and a membrane Geistlich BioOss Collagen Mucograft Seal by a student Group 2 or investigator doctor 3 The allocation to the respective group is carried out randomly using a random generator The entire treatment takes place in all groups under the supervision of one study doctor
Dimensional changes of the bone will be measured after the extraction and after 6 month using CBCT Scans
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None