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

April 27, 2020 updated by: Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Badajoz, Spain, 06001
        • Centro de Implantologia Cirugia Oral y Maxiofacial

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Routine implant placement
No comparison needed
Device: Implant placement
Routine implant placement in the ideal three dimensional implant position

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of peri-implantitis
Time Frame: 3-years
Control by routine x-ray peri-implant bone loss
3-years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

October 18, 2016

First Submitted That Met QC Criteria

October 18, 2016

First Posted (Estimate)

October 19, 2016

Study Record Updates

Last Update Posted (Actual)

April 29, 2020

Last Update Submitted That Met QC Criteria

April 27, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18002909-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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