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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.

NCT01620918 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-12-01

No results posted yet for this study

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.

Conditions

  • Missing Several Teeth
  • Minimum of 2 Dental Implants Needed

Interventions

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.

Sponsors & Collaborators

  • University Ghent

    lead OTHER

Principal Investigators

  • Hugo De Bruyn, DDS, MSc, PhD · University Ghent

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2015-01-31
Completion
2015-08-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01620918 on ClinicalTrials.gov