Clinical trial NCT01620918: Soft Tissue Responses Around Nanostructured Calcium-phosphate-coated Implant Abutments on Dental Implants: Histological, Genetic and Clinical Evaluation in Smokers and Non-smokers.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Missing Several Teeth
Minimum of 2 Dental Implants Needed
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2012-06-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: The soft-tissue attachment around 2 different surfaces at 4 weeks post-implantation.
timeFrame: at 4 weeks post-implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University
Study officials:
affiliation: University Ghent
name: Hugo De Bruyn, DDS, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: