Impact of Buccal Bone Thickness on Pathological Peri-impl... | NCT02939222

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

NCT02939222

Sponsor

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

Status

Withdrawn

Last Update Posted

Apr 29, 2020Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Periimplantitis
Oral Surgery

Interventions

Implant placement

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2016

Primary Completion Date

Dec 1, 2021Estimated

Completion Date

Dec 1, 2023Estimated

First Submitted Date

Oct 18, 2016

First Submission Date that Met QC Criteria

Oct 18, 2016

First Posted Date

Oct 19, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2020

Last Update Posted Date

Apr 29, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Routine implant placement	Other	No comparison needed	Device: Implant placement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Implant placement	Device	Routine implant placement in the ideal three dimensional implant position	Routine implant placement

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centro de Implantologia Cirugia Oral y Maxiofacial		Badajoz		06001	Spain

Condition Browse Module

MeSH Terms

ID	Term
D057873	Peri-Implantitis

Ancestor Terms

ID	Term
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided