Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-28 @ 11:11 PM
Study NCT ID:
NCT05638958
Status:
UNKNOWN
Last Update Posted:
2022-12-06
First Post:
2022-11-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immediate Implants With Customized Abutments
Sponsor:
University Hospital, Geneva
Organization:
Study Overview
Official Title:
Effect of Peri-implant Gap Grafting and Immediate Provisionalization With Customized Healing Abutments on the Stability of Peri-implant Soft Tissues - a Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2022-11
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Tooth extraction is followed by marked alterations of the tissue volume. The resorption process of at least the surrounding mucosa can be altered by using immediate implant placement and additional features such as immediate provisional crown, platform switching and grafting the gap between implant and buccal bone plate. The support of the gingival margin with a provisional crown led to an increase of buccal gingival tissue.
Teeth scheduled for extraction will be used to study the effect of a customized healing abutment.
The following groups will be randomly assigned:
Control: A commercially available healing abutment will be screwed on top of the implant and a collagen sponge will be used to protect the graft.
Test: A customized PEEK abutment mimicking the subgingival emergence of the extracted tooth will be screw retained on top of the implant to seal the extraction site.
Teeth scheduled for extraction will be used to study the effect of a customized healing abutment.
The following groups will be randomly assigned:
Control: A commercially available healing abutment will be screwed on top of the implant and a collagen sponge will be used to protect the graft.
Test: A customized PEEK abutment mimicking the subgingival emergence of the extracted tooth will be screw retained on top of the implant to seal the extraction site.
Detailed Description:
Tooth extraction is followed by marked alterations of the tissue volume. Incorporation of biomaterials into a fresh extraction socket can significantly reduce alveolar resorption but is not able to diminish the biologic process of the buccal bone plate. The resorption process of at least the surrounding mucosa can be altered by using immediate implant placement and additional features such as immediate provisional crown, platform switching and grafting the gap between implant and buccal bone plate. The support of the gingival margin with a provisional crown led to an increase of buccal gingival tissue. Platform switching seems to be a viable option to reduce interproximal bone level alterations and to limit the buccal soft tissue recession. Furthermore, augmenting the defect between the implant and the buccal bone plate has been proven to reduce the resorption process and lead to less shrinkage.
The primary objective is:
\- The implant success
The Secondary objectives are:
* The Changes in mid-facial mucosal recession
* The changes in papilla height
* The changes in soft tissue ridge width
* The aesthetic evaluation
* The implant stability
The primary objective is:
\- The implant success
The Secondary objectives are:
* The Changes in mid-facial mucosal recession
* The changes in papilla height
* The changes in soft tissue ridge width
* The aesthetic evaluation
* The implant stability
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?: