Soft Tissue Responses Around Nanostructured Calcium-phosphate-coated Implant Abutments on Dental Implants: Histological, Genetic and Clinical Evaluation in Smokers and Non-smokers. (STRANDI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01620918|
Recruitment Status : Unknown
Verified December 2014 by University Ghent.
Recruitment status was: Recruiting
First Posted : June 15, 2012
Last Update Posted : December 5, 2014
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Missing Several Teeth Minimum of 2 Dental Implants Needed||Procedure: normal healing abutment Procedure: nano-structured healing abutment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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.|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||January 2015|
|Estimated Study Completion Date :||August 2015|
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.
- The soft-tissue attachment around 2 different surfaces at 4 weeks post-implantation. [ Time Frame: at 4 weeks post-implantation ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01620918
|Contact: Hugo De Bruyn, DDS, MSc, PhD||Hugo.Debruyn@ugent.be|
|Contact: Faris Younes, DDS||Faris.Younes@ugent.be|
|Ghent, Belgium, 9000|
|Contact: Faris Younes, DDS Faris.Younes@ugent.be|
|Principal Investigator: Hugo De Bruyn, DDS, MSc, PhD|
|Principal Investigator:||Hugo De Bruyn, DDS, MSc, PhD||University Ghent|