Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06612684
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
A New Syndesmotomy Technique for Tooth Extractions to Preserve the Alveolar Bone
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A New Syndesmotomy Technique for Tooth Extractions Preserving the Integrity of the Alveolar Bone
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
SINDESM-EXt
Brief Summary:
In both surgical and nor surgical tooth extractions the first phase is done by syndesmotomy This procedure allows to interrupt the fibers of the periodontal ligament Traditionally syndesmotomy is done by manual instruments Usually the manual approach leads to the loss of the vestibular cortical plate due to the size of those instruments
The piezoelectric surgery device provides an alternative to manual instruments Its advantages are selectivity for hard tissues better cut control protection of soft tissue vessels and nerves post-op pain and discomfort reduction
The aim of this study is to evaluate a piezosurgery driven syndesmotomy technique during tooth extraction
The piezoelectric surgery device provides an alternative to manual instruments Its advantages are selectivity for hard tissues better cut control protection of soft tissue vessels and nerves post-op pain and discomfort reduction
The aim of this study is to evaluate a piezosurgery driven syndesmotomy technique during tooth extraction
Detailed Description:
Piezoelectric bone surgery is a recent and innovative technology permitting a selective cut of mineralized tissue while sparing soft tissue Similar to a dental scaler a high frequency vibration in the range of 25-35 kHz is transmitted to a metallic tip The handpiece of the instrument is equipped with a sterile irrigation system and light-emitting diode LED light which improves visibility and overall safety Piezoelectric surgery is particularly useful when performing delicate bone procedures such as periodontal or endodontic surgery It is also indicated when performing more invasive bone surgery such as maxillectomy mandibulectomy and condylectomy where preservation of neurovascular structures is important Piezoelectric surgery is still employed in tooth extraction of third lower molars In literature there are low evidence of the use of piezoelectric surgery for single-rooted tooth extraction
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