Ridge Preservation Comparing Simultaneous vs. Delayed Grafting

September 8, 2020 updated by: Henry Greenwell, University of Louisville

Ridge Preservation Comparing the Traditional Approach vs. Early Implant Placement With Simultaneous Contour Augmentation

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Graduate Periodontics, UofL School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Delayed Grafting
8 weeks after extraction implant placement and simultaneous osseous grafting.
Procedure: Delayed graft
8 weeks post-extraction 15 test patients will receive implant placement plus osseous grafting.
Active Comparator: Simultaneous Grafting
At the time of extraction the socket will be grafted and implant placed 4 months later.
Procedure: Simultaneous graft
At the time of extraction osseous graft will be placed in the socket and implant placed 4 months later.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2018

Primary Completion (Actual)

April 26, 2019

Study Completion (Actual)

April 26, 2019

Study Registration Dates

First Submitted

June 13, 2018

First Submitted That Met QC Criteria

July 6, 2018

First Posted (Actual)

July 9, 2018

Study Record Updates

Last Update Posted (Actual)

September 10, 2020

Last Update Submitted That Met QC Criteria

September 8, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18.0348

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tooth Loss

Clinical Trials on Delayed graft

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe