Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-03-02 @ 4:01 PM
Study NCT ID:
NCT01620918
Status:
COMPLETED
Last Update Posted:
2021-12-01
First Post:
2012-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Soft Tissue Responses Around Nanostructured Calcium-phosphate-coated Implant Abutments on Dental Implants: Histological, Genetic and Clinical Evaluation in Smokers and Non-smokers.
Sponsor:
University Ghent
Organization:
Study Overview
Official Title:
Soft Tissue Responses Around Nanostructured Calcium-phosphate-coated Implant Abutments on Dental Implants: Histological, Genetic and Clinical Evaluation in Smokers and Non-smokers.
Status:
COMPLETED
Status Verified Date:
2021-11
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:
STRANDI
Brief Summary:
* Baseline:
* Standard preparation of the osteotomy
* Placement of 2 dental implants
* On each implant one of both types of healing abutments is placed
* Suturing
* Standardized radiography to measure bone-levels at baseline
* Digital impression of the surrounding gingiva with an intra-oral scanner (a non-invasive method) to measure the baseline level of the gingiva
* 2 weeks after Baseline:
o Removal of the sutures
* 4 weeks after Baseline:
* A 2nd digital impression of the soft tissue with an intra-oral scanner
* Collecting crevicular fluid by placing paperpoints in the provided apertures in the healing abutments for 60 seconds without bleeding.
* Measuring of the pocket depth in the provided apertures in the healing abutments with an automated probe.
* Removal of the Healing Abutment with the attached soft tissue en-bloque.
* Placement of a new, regular, Encode Healing Abutment.
* 10 weeks after Baseline:
* Start of standard prosthetic procedure. In this study we expect that the soft tissue attachment (i.e. the gingival attachment) will be stronger and earlier achieved at the nano-structured healing abutments than at the normal, uncoated healing abutments. This would lead to a more stable soft tissue complex on the long rung and thus providing a more predictable aesthetic outcome. Secondly, a stronger attachment would mean a stronger barrier against micro-organisms and might influence the occurrence of peri-implantitis.
* Standard preparation of the osteotomy
* Placement of 2 dental implants
* On each implant one of both types of healing abutments is placed
* Suturing
* Standardized radiography to measure bone-levels at baseline
* Digital impression of the surrounding gingiva with an intra-oral scanner (a non-invasive method) to measure the baseline level of the gingiva
* 2 weeks after Baseline:
o Removal of the sutures
* 4 weeks after Baseline:
* A 2nd digital impression of the soft tissue with an intra-oral scanner
* Collecting crevicular fluid by placing paperpoints in the provided apertures in the healing abutments for 60 seconds without bleeding.
* Measuring of the pocket depth in the provided apertures in the healing abutments with an automated probe.
* Removal of the Healing Abutment with the attached soft tissue en-bloque.
* Placement of a new, regular, Encode Healing Abutment.
* 10 weeks after Baseline:
* Start of standard prosthetic procedure. In this study we expect that the soft tissue attachment (i.e. the gingival attachment) will be stronger and earlier achieved at the nano-structured healing abutments than at the normal, uncoated healing abutments. This would lead to a more stable soft tissue complex on the long rung and thus providing a more predictable aesthetic outcome. Secondly, a stronger attachment would mean a stronger barrier against micro-organisms and might influence the occurrence of peri-implantitis.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: