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Impact of Buccal Bone Thickness on Pathological Peri-implant Bone Loss: A 3-year Prospective Cohort Study

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ClinicalTrials.gov Identifier: NCT02939222
Recruitment Status : Recruiting
First Posted : October 19, 2016
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

Brief Summary:
Implant placement may trigger bone trauma, which might result in 3-dimensional bone changes. While the process of peri-implant disease is not well understood, implant position within the bony structure might play a role. However, there is no data available on this regard.

Condition or disease Intervention/treatment Phase
Periimplantitis Oral Surgery Device: Implant placement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Buccal Bone Thickness on Pathological Peri-implant Bone Loss: A 3-year Prospective Cohort Study
Study Start Date : October 1, 2016
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2023

Arm Intervention/treatment
Routine implant placement
No comparison needed
Device: Implant placement
Routine implant placement in the ideal three dimensional implant position




Primary Outcome Measures :
  1. Frequency of peri-implantitis [ Time Frame: 3-years ]
    Control by routine x-ray peri-implant bone loss



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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
Criteria

Inclusion Criteria:

  • Patients between 18 and 80 years old
  • Patients requiring oral rehabilitation through supported prosthesis
  • Patients with partial edentulism
  • No antibiotic in the last 2 months
  • No smoking or smoking <10 cigarettes a day

Exclusion Criteria:

  • Systemic diseases uncontrolled
  • Implants that because prosthetic characteristics can not be registered probing depth or attachment level appropriately
  • Smoking> 10 cigarettes a day
  • Pregnant Patients
  • Implants that can not be followed in CICOM
  • Patients who do not return to regular maintenance therapy every 3-6meses
  • Patients who are not controlled periodontal disease

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): NCT02939222


Locations
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Spain
Centro de Implantologia Cirugia Oral y Maxiofacial Recruiting
Badajoz, Spain, 06001
Contact: Alberto Monje, DDS, MS    +41798836264    amonjec@umich.edu   
Sponsors and Collaborators
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

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Responsible Party: Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
ClinicalTrials.gov Identifier: NCT02939222     History of Changes
Other Study ID Numbers: 18002909-2
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: October 2016

Additional relevant MeSH terms:
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Peri-Implantitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases