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Ridge Preservation Comparing Simultaneous vs. Delayed Grafting

Primary Purpose

Tooth Loss

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Delayed graft
Simultaneous graft
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Graduate Periodontics, UofL School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Delayed Grafting

Simultaneous Grafting

Arm Description

8 weeks after extraction implant placement and simultaneous osseous grafting.

At the time of extraction the socket will be grafted and implant placed 4 months later.

Outcomes

Primary Outcome Measures

Final ridge width for simultaneous and delayed grafting treatment.
Measure final ridge width to determine if adequate bone is available.

Secondary Outcome Measures

Soft tissue thickness
Facial and occlusal
Histology
Histologic composition for control group only
Implant dehiscence
Implant dehiscence

Full Information

First Posted
June 13, 2018
Last Updated
September 8, 2020
Sponsor
University of Louisville
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1. Study Identification

Unique Protocol Identification Number
NCT03580798
Brief Title
Ridge Preservation Comparing Simultaneous vs. Delayed Grafting
Official Title
Ridge Preservation Comparing the Traditional Approach vs. Early Implant Placement With Simultaneous Contour Augmentation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
Not enough patients available
Study Start Date
November 8, 2018 (Actual)
Primary Completion Date
April 26, 2019 (Actual)
Study Completion Date
April 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Delayed Grafting
Arm Type
Experimental
Arm Description
8 weeks after extraction implant placement and simultaneous osseous grafting.
Arm Title
Simultaneous Grafting
Arm Type
Active Comparator
Arm Description
At the time of extraction the socket will be grafted and implant placed 4 months later.
Intervention Type
Procedure
Intervention Name(s)
Delayed graft
Intervention Description
8 weeks post-extraction 15 test patients will receive implant placement plus osseous grafting.
Intervention Type
Procedure
Intervention Name(s)
Simultaneous graft
Intervention Description
At the time of extraction osseous graft will be placed in the socket and implant placed 4 months later.
Primary Outcome Measure Information:
Title
Final ridge width for simultaneous and delayed grafting treatment.
Description
Measure final ridge width to determine if adequate bone is available.
Time Frame
16 to 20 weeks
Secondary Outcome Measure Information:
Title
Soft tissue thickness
Description
Facial and occlusal
Time Frame
16 to 20 weeks
Title
Histology
Description
Histologic composition for control group only
Time Frame
16 weeks
Title
Implant dehiscence
Description
Implant dehiscence
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Greenwell, DMD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
Graduate Periodontics, UofL School of Dentistry
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Ridge Preservation Comparing Simultaneous vs. Delayed Grafting

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