Trial record 11 of 3559 for:    Louisville

Clinical Effects of Hard and Soft Tissue Grafting With Dental Implants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03580811
Recruitment Status : Not yet recruiting
First Posted : July 9, 2018
Last Update Posted : July 9, 2018
Information provided by (Responsible Party):
Henry Greenwell, University of Louisville

Brief Summary:
The study will be done to see if Implant placement and simultaneous grafting using alloderm alone will result in the same facial ridge contour and soft tissue thickness as alloderm plus bovine derived xenograft. Is the facial soft tissue contour and thickness for alloderm plus bovine derived xenograft is significantly increased compared to alloderm alone.

Condition or disease Intervention/treatment Phase
Dental Implants Device: Dental Implant &ADMG Device: Dental implant & ADMG & BDX Not Applicable

Detailed Description:
Thirty sequentially entered patients will have a dental implant placed in maxillary sites from 4 to 13. Any implant system is acceptable since the objective of the study is to evaluate soft tissue contour due to graft placement, not to evaluate the implant. Once selected for participation immediately prior to treatment, they are randomized for a treatment group by a coin toss. Fifteen patients will receive Alloderm alone (Positive Control Group) while another fifteen will receive Alloderm plus Bovine derived Xenograft (Test Group). The graft will be placed simultaneously with the dental implant. A blinded examiner Dr.Jodie Lusby will be used. Should the examiner become unblinded the subject will be excluded from the study. Means and standard deviations will be calculated for all parameters. A paired test will be used to evaluate the statistical significance of the differences between initial and final data. An unpaired t-test will be used to evaluate statistical differences between the test and control groups. A sample size of 12 will afford ≥ 80% statistical power to detect a difference of 0.4 mm soft tissue thickness between groups. P value will be set at p≤0.05.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: two groups of 15 patients . One with soft tissue grafting and implant placement and other with soft and hard tissue grafting with implant placement.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Clinical Effect of Simultaneous Grafting With Implant Placement Comparing Soft Tissue Grafting Alone to Combined Hard and Soft Tissue Grafting
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : January 30, 2019
Estimated Study Completion Date : June 15, 2019

Arm Intervention/treatment
Active Comparator: Dental Implant & ADMG
Dental implant placed with simultaneous grafting using one layer of ADMG
Device: Dental Implant &ADMG
A dental implant will be placed and the buccal soft tissue will be grafted using ADMG .

Experimental: Dental implant & ADMG & BDX
Dental implant placed plus simultaneous grafting using ADMG with BDX
Device: Dental Implant &ADMG
A dental implant will be placed and the buccal soft tissue will be grafted using ADMG .

Device: Dental implant & ADMG & BDX
Dental Implant will be placed with ADMG that covers the BDX

Primary Outcome Measures :
  1. Buccal soft tissue contour around dental implant [ Time Frame: 3 months ]
    Contour will be categorized as concave,flat or convex(subjective categories).

Secondary Outcome Measures :
  1. Buccal soft tissue thickness around dental implants [ Time Frame: 3 months ]
    The thickness will be measured with an endodontic file using a rubber stopper(objective measure of tissue thickness by penetrating tissue and measuring thickness in millimeters (mm).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Have one edentulous site bordered by 2 teeth in maxillary sites from second premolar to second premolar (maxillary 4 to 13) to receive an implant with simultaneous grafting with an ADMG with or without BDX.
  2. Healthy persons at least 18 years old.
  3. Understands and has signed the informed consent.

Exclusion Criteria:

  1. Patients with uncontrolled diabetes, immune disease, or any systemic disease that significantly affects the periodontium.
  2. Previous head and neck radiation.
  3. Patients who have taken oral bisphosphonates for > 3 years or any IV bisphosphonates.
  4. Smokers (or other tobacco habits that might interfere with soft tissue healing).
  5. Patients who need prophylactic antibiotics prior to dental procedures.
  6. Patients with allergies to any medication or material used in the study, or that would adversely affect study procedures.
  7. Chemotherapy in the previous 12 months.
  8. Psychological problems that would interfere with treatment.
  9. Pregnant subjects will be excluded due to risk of miscarriage
  10. Patients unable or unwilling to sign the informed consent.

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 identifier (NCT number): NCT03580811

Contact: Henry Greenwell, MSD 502-852-1213

United States, Kentucky
University of Louisville Grad Periodontics Not yet recruiting
Louisville, Kentucky, United States, 40202
Contact: Rajarshi GuhaNiyogi, MS    502-601-1603   
Sponsors and Collaborators
University of Louisville
Principal Investigator: Henry Greenwell, MSD University of Louisville

Responsible Party: Henry Greenwell, Professor, University of Louisville Identifier: NCT03580811     History of Changes
Other Study ID Numbers: 18.0470
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

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

Keywords provided by Henry Greenwell, University of Louisville:
Dental Implants
Alveolar bone grafting