Ridge Preservation Comparing Simultaneous vs. Delayed Gra... | NCT03580798

Studies
Ridge Preservation Comparing Simultaneous vs. Delayed Grafting

NCT03580798

Sponsor

University of Louisville

Status

Terminated

Last Update Posted

Sep 10, 2020Actual

Enrollment

7Actual

Phase

Not Applicable

Conditions

Tooth Loss

Interventions

Delayed graft
Simultaneous graft

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

Sep 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not enough patients available

Expanded Access Info

Start Date

Nov 8, 2018Actual

Primary Completion Date

Apr 26, 2019Actual

Completion Date

Apr 26, 2019Actual

First Submitted Date

Jun 13, 2018

First Submission Date that Met QC Criteria

Jul 6, 2018

First Posted Date

Jul 9, 2018Actual

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

Sep 8, 2020

Last Update Posted Date

Sep 10, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

Comparison of the clinical healing of simultaneous vs. delayed grafting for dental implant placement.

Detailed Description

The primary aims of this study are to compare the clinical and histologic results of a traditional ridge preservation with implant placement at 16 weeks (control group) with early implant placement (8 weeks) with simultaneous contour augmentation as described by Buser (test group).

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

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Delayed Grafting	Experimental	8 weeks after extraction implant placement and simultaneous osseous grafting.	Procedure: Delayed graft
Simultaneous Grafting	Active Comparator	At the time of extraction the socket will be grafted and implant placed 4 months later.	Procedure: Simultaneous graft

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Delayed graft	Procedure	8 weeks post-extraction 15 test patients will receive implant placement plus osseous grafting.	Delayed Grafting

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Final ridge width for simultaneous and delayed grafting treatment.	Measure final ridge width to determine if adequate bone is available.	16 to 20 weeks

Secondary Outcomes

Measure	Description	Time Frame
Soft tissue thickness	Facial and occlusal	16 to 20 weeks
Histology	Histologic composition for control group only	16 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have one non-molar maxillary tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by 2 teeth.
Healthy persons at least 18 years old.
Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria:

Patients with debilitating systemic disease, or diseases that have a clinically significant effect on the periodontium.
Exclude any molar tooth.
Presence of or history of osteonecrosis of jaws.
Patients with current or previous history of IV bisphosphonates, irrespective of duration.
Patients taking oral bisphosphonates for ≥ 3 years.
Pregnant women.
Allergy to any material or medication used in the study.
Patients who need prophylactic antibiotics prior to dental procedures.
Previous head and neck radiation therapy.
Chemotherapy in the previous 12 months.

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, UofL School of Dentistry		Louisville	Kentucky	40202	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016388	Tooth Loss

Ancestor Terms

ID	Term
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D014076	Tooth Diseases

Browse Leaves

Not provided

Browse Branches

Not provided