Minimum of 2 Dental Implants Needed, Missing Several Teeth
Conditions
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.
Interventions
PROCEDUREnormal healing abutment
Patient receives the normal, uncoated healing abutment on 1 of his (minimal 2) dental implants.
PROCEDUREnano-structured healing abutment
Patient receives the nano-structured healing abutment on 1 of his (minimal 2) dental implants.
Sponsors
University Ghent
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients are eligible for this study if they are in need of minimum 2 dental implants and have sufficient bone to place these implants
Exclusion criteria
* All patients with limited bone * Periodontally compromised patients * Patients who took antibiotics 3 months before implantation * Patients with uncontrolled diabetes * Pregnant patients * Patients who received radiotherapy in the head/neck region * Patients under chemotherapy * Patients who had intravenous use of bisphosphonates
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The soft-tissue attachment around 2 different surfaces at 4 weeks post-implantation. | 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. |
Countries
Belgium
Outcome results
None listed