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 recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University Ghent.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
University Ghent
ClinicalTrials.gov Identifier:
NCT01620918
First received: June 13, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose
  • 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.

Condition Intervention
Missing Several Teeth
Minimum of 2 Dental Implants Needed
Procedure: normal healing abutment
Procedure: nano-structured healing abutment

Study Type: Interventional
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.


Estimated Enrollment: 100
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)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01620918

Contacts
Contact: Hugo De Bruyn, DDS, MSc, PhD Hugo.Debruyn@ugent.be
Contact: Faris Younes, DDS Faris.Younes@ugent.be

Locations
Belgium
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
University Ghent
Investigators
Principal Investigator: Hugo De Bruyn, DDS, MSc, PhD University Ghent
  More Information

No publications provided

Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT01620918     History of Changes
Other Study ID Numbers: 2012/341
Study First Received: June 13, 2012
Last Updated: June 13, 2012
Health Authority: Belgium: Ethics Committee

ClinicalTrials.gov processed this record on August 28, 2014