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Soft Tissue Responses Around Nanostructured Calcium-phosphate-coated Implant Abutments on Dental Implants: Histological, Genetic and Clinical Evaluation in Smokers and Non-smokers. (STRANDI)

U

University Ghent

Status

Completed

Conditions

Minimum of 2 Dental Implants Needed
Missing Several Teeth

Treatments

Procedure: nano-structured healing abutment
Procedure: normal healing abutment

Study type

Interventional

Funder types

Other

Identifiers

NCT01620918
2012/341

Details and patient eligibility

About

  • 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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

2 types of healing abutment
Experimental group
Description:
Patients who are in need of minimal 2 dental implants, who will receive both types of healing abutments.
Treatment:
Procedure: normal healing abutment
Procedure: nano-structured healing abutment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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