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OpenTrials
Completed

NCT Number: NCT01620918

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

* 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

normal healing abutment

Procedure

Patient receives the normal, uncoated healing abutment on 1 of his (minimal 2) dental implants.

nano-structured healing abutment

Procedure

Patient receives the nano-structured healing abutment on 1 of his (minimal 2) dental implants.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Acronym: STRANDI

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 15, 2012
Registry last updated
Dec 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.