Back to resultsImpact of Buccal Bone Thickness on Pathological Peri-implant Bone Loss: A 3-year Prospective Cohort Study
Primary Purpose
Periimplantitis, Oral Surgery
Status
Withdrawn
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Implant placement
Sponsored by
About this trial
This is an interventional treatment trial for Periimplantitis
Eligibility 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
Sites / Locations
- Centro de Implantologia Cirugia Oral y Maxiofacial
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Routine implant placement
Arm Description
No comparison needed
Outcomes
Primary Outcome Measures
Frequency of peri-implantitis
Control by routine x-ray peri-implant bone loss
Secondary Outcome Measures
Full Information
NCT ID
NCT02939222
First Posted
October 18, 2016
Last Updated
April 27, 2020
Sponsor
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
1. Study Identification
Unique Protocol Identification Number
NCT02939222
Brief Title
Impact of Buccal Bone Thickness on Pathological Peri-implant Bone Loss: A 3-year Prospective Cohort Study
Official Title
Impact of Buccal Bone Thickness on Pathological Peri-implant Bone Loss: A 3-year Prospective Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Withdrawn
Study Start Date
October 1, 2016 (undefined)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periimplantitis, Oral Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Routine implant placement
Arm Type
Other
Arm Description
No comparison needed
Intervention Type
Device
Intervention Name(s)
Implant placement
Intervention Description
Routine implant placement in the ideal three dimensional implant position
Primary Outcome Measure Information:
Title
Frequency of peri-implantitis
Description
Control by routine x-ray peri-implant bone loss
Time Frame
3-years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Centro de Implantologia Cirugia Oral y Maxiofacial
City
Badajoz
ZIP/Postal Code
06001
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Impact of Buccal Bone Thickness on Pathological Peri-implant Bone Loss: A 3-year Prospective Cohort Study
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