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The Role of Bleeding at Implant Placement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03705247
Recruitment Status : Recruiting
First Posted : October 15, 2018
Last Update Posted : January 17, 2019
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:
Angiogenesis is inherently associated to bone formation and healing. During implant osseointegration, a successive and successful angiogenic processes has to occur to promote bone formation. In 1969, Branemark et al. demonstrated that direct contact between bone and titanium implant surface was possible, defining osseointegration as "the direct, structural, and functional contact between live bone and the surface of a functionally loaded implant". Consequently, the need of an empirical measurement appeared. With the introduction of resonance frequency analysis (RFA), it is now possible to measure the degree of implant stability at any time during the course of implant treatment and loading. In this way, changes in implant stability can be monitored over the time and it is likely possible to find implants at risk of failure before they become loose. The rationale of this study is to analyse how important a good vascularization is for the future bone formation around dental implants.

Condition or disease
Bleeding Angiogenesis Peri-Implantitis

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Study Type : Observational
Estimated Enrollment : 128 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Bleeding at Implant Placement: a Prospective Observational Study
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding




Primary Outcome Measures :
  1. Correlation between bleeding during implant placement and marginal bone loss [ Time Frame: 1 year ]
    Peri-implant bone loss after 1 year from the implant placement


Secondary Outcome Measures :
  1. Correlation between bleeding during implant placement and implant stability quotient (ISQ) values [ Time Frame: 3 months ]
    Correlation between bleeding during implant placement and implant stability quotient (ISQ) values



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients who come to the Unit of Periodontology (UZ Leuven, St. Rafaël), in need of implant rehabilitation, will be evaluated for initial study eligibility during a screening visit. Patients shall be advised of the need to attend follow-up visits: 3 months after implant placement (at abutment placement visit) and 1 year, the latter to analyse the early bone remodelling.
Criteria

Inclusion Criteria:

  • Males or females American Society of Anesthesiologists classification (ASA) I or II, between 18 to 80 years of age
  • Patient in good general health as documented by self-assessment.
  • Patients needing implant rehabilitation in the upper or lower jaw.
  • Patients must be committed to the study and must be willing to sign the informed consent.

Exclusion Criteria:

  • Any systemic medical condition that could interfere with the surgical procedure or planned treatment.
  • Immunosuppression, Diabetes, Anticoagulation or Antiaggregatory medication.
  • Current pregnancy or breast feeding/ lactating at the time of recruitment.
  • Radiotherapy or Chemotherapy in head and neck area.
  • Intravenous and oral bisphosphonate therapy.
  • Patients smoking >20 cigarettes a day.
  • Unwillingness to return for the follow-up examination.
  • Conditions or circumstances, in the opinion of the investigator, which could represent a general contra-indication for surgical procedure or would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unrealistic expectations.

Local exclusion criteria:

  • Immediate implant placement after tooth extraction.
  • Risk of extra bleeding due to inflammatory or infectious processes near the zone of implantation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03705247


Contacts
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Contact: Ana Castro +32 16 37 37 48 anabelen.castrosarda@kuleuven.be

Locations
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Belgium
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Ana Castro, Drs    +32 16 37 37 48    anabelen.castrosarda@kuleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03705247    
Other Study ID Numbers: S58575
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitaire Ziekenhuizen Leuven:
Dental Implants
Additional relevant MeSH terms:
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Peri-Implantitis
Hemorrhage
Pathologic Processes
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases