NCT02939222

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

April 29, 2020

Status Verified

March 1, 2020

Enrollment Period

5.2 years

First QC Date

October 18, 2016

Last Update Submit

April 27, 2020

Conditions

PeriimplantitisOral Surgery

Outcome Measures

Primary Outcomes (1)

  • Frequency of peri-implantitis

    Control by routine x-ray peri-implant bone loss

    3-years

Study Arms (1)

Routine implant placement

OTHER

No comparison needed

Device: Implant placement

Interventions

Implant placementDEVICE

Routine implant placement in the ideal three dimensional implant position

Routine implant placement

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Implantologia Cirugia Oral y Maxiofacial

Badajoz, 06001, Spain

Location

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2016

First Posted

October 19, 2016

Study Start

October 1, 2016

Primary Completion

December 1, 2021

Study Completion

December 1, 2023

Last Updated

April 29, 2020

Record last verified: 2020-03

Locations

ES(1)