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Ridge Preservation Comparing Simultaneous vs. Delayed Grafting

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ClinicalTrials.gov Identifier: NCT03580798
Recruitment Status : Not yet recruiting
First Posted : July 9, 2018
Last Update Posted : July 9, 2018
Sponsor:
Information provided by (Responsible Party):
Henry Greenwell, University of Louisville

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

Condition or disease Intervention/treatment Phase
Tooth Loss Procedure: Delayed graft Procedure: Simultaneous graft Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ridge Preservation Comparing the Traditional Approach vs. Early Implant Placement With Simultaneous Contour Augmentation
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : May 2019

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Soft tissue thickness [ Time Frame: 16 to 20 weeks ]
    Facial and occlusal

  2. Histology [ Time Frame: 16 weeks ]
    Histologic composition for control group only

  3. Implant dehiscence [ Time Frame: 20 weeks ]
    Implant dehiscence



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03580798


Contacts
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Contact: Katrine F Andreasen, DMD 5029397614 kfandr01@louisville.edu
Contact: Rajarshi Niyogi, DDS 5026011603 rajarshi.guhaniyogi@louisville.edu

Sponsors and Collaborators
University of Louisville
Investigators
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Principal Investigator: Henry Greenwell, DMD University of Louisville

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Responsible Party: Henry Greenwell, Director of Graduate Peridontics, University of Louisville
ClinicalTrials.gov Identifier: NCT03580798     History of Changes
Other Study ID Numbers: 18.0348
First Posted: July 9, 2018    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Tooth Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases