Ridge Augmentation Without Primary Closure | NCT01901783

Studies
Ridge Augmentation Without Primary Closure

NCT01901783

Sponsor

University of Louisville

Status

Completed

Last Update Posted

Dec 8, 2016Estimated

Enrollment

18Actual

Phase

Not Applicable

Conditions

Alveolar Ridge Augmentation

Interventions

With primary closure
Without primary closure

Countries

United States

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

Dec 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Jul 12, 2013

First Submission Date that Met QC Criteria

Jul 16, 2013

First Posted Date

Jul 17, 2013Estimated

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

Dec 6, 2016

Last Update Posted Date

Dec 8, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

This study is designed to compare the clinical and histologic results of ridge augmentation with and without primary closure over the barrier membrane. The hypothesis is that there will be no difference in crestal ridge width between the two groups.

Detailed Description

A maximum of 30 patients will be selected that meet the following criteria:

Inclusion Criteria

At least a one tooth area with a ridge defect, treatment planned to receive a dental implant. The site must be bordered by at least one tooth.
Healthy person that is at least 18 years old.
Patient understands and signs an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria

Patients with debilitating systemic diseases, diseases that affect the periodontium, or psychological problems that would interfere with treatment.
Previous head and neck radiation or chemotherapy within the previous 12 months.
Patients with known allergy to any of the materials that will be used in the study.
Smokers.
Patients who need prophylactic antibiotics prior to dental procedures.
Patients on long-term steroid therapy or oral bisphosphonates > 3 years or any IV biosphosphonates.
Patients who are pregnant.

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

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
With primary closure	Active Comparator	The ridge augmentation graft will be covered with a barrier membrane and the soft tissue will be primarily closed.	Procedure: With primary closure
Without primary closure	Experimental	The ridge augmentation graft will be covered with a barrier membrane and the soft tissue will not be primarily closed.	Procedure: Without primary closure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
With primary closure	Procedure	A cancellous block allograft will be placed for ridge augmentation and covered with a barrier membrane. The soft tissue will be primarily closed over the membrane.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Crestal ridge width	The ridge width at the crest will be compared between the two treatment groups.	4 months

Secondary Outcomes

Measure	Description	Time Frame
Percent vital bone	The percent vital bone will be compared between the two treatment groups.	4 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

At least a one tooth area with a ridge defect, treatment planned to receive a dental implant. The site must be bordered by at least one tooth.
Healthy person that is at least 18 years old.
Patient understands and signs an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria:

Patients with debilitating systemic diseases, diseases that affect the periodontium, or psychological problems that would interfere with treatment.
Previous head and neck radiation or chemotherapy within the previous 12 months.
Patients with known allergy to any of the materials that will be used in the study.
Smokers.
Patients who need prophylactic antibiotics prior to dental procedures.
Patients on long-term steroid therapy or oral bisphosphonates > 3 years or any IV biosphosphonates.
Patients who are pregnant.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Henry Greenwell, DMD	University of Louisville	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Graduate Periodontics Clinic University of Louisville		Louisville	Kentucky	40202	United States