Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05722041
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2022-08-11
Brief Title:
Soft Tissue Volume Changes in Posterior Socket Sealing Abutment
Sponsor:
Aula Dental Avanzada
Organization:
Aula Dental Avanzada
Study Overview
Official Title:
Soft Tissue Volume Changes in the Posterior Area With Socket Sealing Abutment Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim is to clinically evaluate the effect of the alveolar sealing technique using a customised abutment on soft tissue volume changes following molar extraction and immediate dental implant placement
Detailed Description:
A sample of 20 patients in ASAI health status who agree to be involved in the study after giving their consent and who require immediate post-extraction implant treatment in the molar area will be recruited
The soft tissue status before and 6 months after tooth extraction will be recorded by means of a digital impression taken with the same intraoral scanner
The patient will be asked to complete a 7-question questionnaire to inform us about his or her perception of the therapeutic process and the final result
A comparative volume measurement will be made by digitally superimposing the two mesh files obtained before and 6 months after the treatment
Statistical data will be analysed by an external statistician and conclusions will be drawn about the effect of the technique on soft tissue volume as well as the patients perception of the procedure and its outcome
The soft tissue status before and 6 months after tooth extraction will be recorded by means of a digital impression taken with the same intraoral scanner
The patient will be asked to complete a 7-question questionnaire to inform us about his or her perception of the therapeutic process and the final result
A comparative volume measurement will be made by digitally superimposing the two mesh files obtained before and 6 months after the treatment
Statistical data will be analysed by an external statistician and conclusions will be drawn about the effect of the technique on soft tissue volume as well as the patients perception of the procedure and its outcome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None