Soft Tissue Responses Around Nanostructured Calcium-phosphate-coated Implant Abutments on Dental Implants: Histological, Genetic and Clinical Evaluation in Smokers and Non-smokers. (STRANDI)
This study is not yet open for participant recruitment.
Verified June 2012 by University Ghent
Information provided by (Responsible Party):
First received: June 13, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
- Standard preparation of the osteotomy
- Placement of 2 dental implants
- On each implant one of both types of healing abutments is placed
- 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.
Missing Several Teeth
Minimum of 2 Dental Implants Needed
Procedure: normal healing abutment
Procedure: nano-structured healing abutment
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|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.|
Resource links provided by NLM:
Further study details as provided by University Ghent:
Primary Outcome Measures:
- The soft-tissue attachment around 2 different surfaces at 4 weeks post-implantation. [ Time Frame: at 4 weeks post-implantation ] [ Designated as safety issue: No ]Genetic evaluation (through Polymerase Chain Reaction, PCR, the tissue will be detected for certain growth factors), histomorphometric analysis to measure the actual percentage of the surface on which the gingiva is attached to, clinical evaluation of the strength of the attachment through means of an automated probe.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||August 2013|
|Estimated Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Experimental: 2 types of healing abutment
Patients who are in need of minimal 2 dental implants, who will receive both types of healing abutments.
Procedure: normal healing abutment
Patient receives the normal, uncoated healing abutment on 1 of his (minimal 2) dental implants.Procedure: nano-structured healing abutment
Patient receives the nano-structured healing abutment on 1 of his (minimal 2) dental implants.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01620918
|Contact: Hugo De Bruyn, DDS, MSc, PhD||Hugo.Debruyn@ugent.be|
|Contact: Faris Younes, DDS||Faris.Younes@ugent.be|
|Ghent University||Not yet recruiting|
|Ghent, Belgium, 9000|
|Contact: Faris Younes, DDS Faris.Younes@ugent.be|
|Principal Investigator: Hugo De Bruyn, DDS, MSc, PhD|
Sponsors and Collaborators
|Principal Investigator:||Hugo De Bruyn, DDS, MSc, PhD||University Ghent|