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Trial record 38 of 3400 for:    Louisville

Root Coverage With Acellular Dermal Matrix and Bovine Derived Osseous

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ClinicalTrials.gov Identifier: NCT03582995
Recruitment Status : Not yet recruiting
First Posted : July 11, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Henry Greenwell, University of Louisville

Brief Summary:
The study will consist of a randomized controlled clinical study trial comparing the results of coronally positioned flap with AlloDerm GBR plus bovine derived xenograft versus coronally positioned tunnel with AlloDerm GBR plus bovine derived xenograft in approximately 30 patients (15 per group). All materials used in the study are FDA approved.

Condition or disease Intervention/treatment Phase
Recession, Gingival Procedure: Flap Surgery for root coverage with Alloderm and xenograft Procedure: Tunnel Surgery for root coverage with Alloderm and xenograft Not Applicable

Detailed Description:

Patients will be assigned to one of two treatment groups. In the positive control group, BX will be placed over the root and bone surface of the defect, covered with ADM GBR® and sutured using a continuous sling suture technique (line angle to line angle) with a Maxon 5-0, 3/8 circle 13 mm needle (Dodge et. al, 1998). The coronally positioned flap will be sutured separately and coronally positioned using a continuous sling suture technique (papilla to papilla sutures) with a Maxon 5-0, 3/8 circle 13 mm needle. In the test group, BX will be placed over the root and bone surface of the defect, covered with ADM GBR® and sutured together using a continuous sling suture technique (line angle to line angle) with a Maxon 5-0, 3/8 circle 13 mm needle. The coronally positioned tunnel will be sutured together and coronally positioned using a continuous sling suture technique (line angle to line angle) with a Maxon 5-0, 3/8 circle 13 mm needle.

Post-operative instructions will be given to the patients along with prescriptions, in appropriate cases, for systemic doxycycline 100 mg once a day for 14 days; an anti-inflammatory agent (naproxen 375 mg q12h for 7 days); an analgesic (hydrocodone/acetaminophen 5/325mg q6-8h prn pain); a steroid, Medrol dose pack, 21 tablets of 4 mg methylprednisolone; 6 tablets on day 1, 5 on day 2, decrease by 1/day until last tablet dose on day 6, or dexamethazone 1mg, 18 tablets, 3 tablets/day for 1st3 days, 2/day for the next 3 days, 1/day for the last 3 days (always taken in the morning).

All patients will be seen at week 1 or 2, 4, 8, 16 and 24, at which time the final exam will be completed. Sutures will be removed between weeks 4-8, as indicated. Post-operative visits will consist of supragingival plaque removal and oral hygiene reinforcement. Any patient who develops any adverse reaction to the materials used or shows attachment loss ≥2.0 mm will be exited from the study and will receive the appropriate treatment.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Root Coverage With Acellular Dermal Matrix and Bovine Derived Osseous Xenograft Using Either a Coronally Positioned Tunnel or Coronally Positioned Flap
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : May 2019

Arm Intervention/treatment
Active Comparator: Flap Surgery for root coverage with Alloderm and xenograft
Root coverage surgery using a flap technique
Procedure: Flap Surgery for root coverage with Alloderm and xenograft
A coronally positioned FLAP technique with AlloDerm® GBR and osseous xenograft will be used for root coverage

Experimental: Tunnel Surgery for root coverage with Alloderm and xenograft
Root coverage surgery using a tunnel technique
Procedure: Tunnel Surgery for root coverage with Alloderm and xenograft
A coronally positioned TUNNEL technique with AlloDerm® GBR and osseous xenograft will be used for root coverage.




Primary Outcome Measures :
  1. Percentage of root coverage [ Time Frame: 4 months ]
    Initial and final recession will be measured from the cementoenamel junction to the gingival margin in millimeters. Root coverage will be determined by the amount of initial recession minus the final recession. Percent root coverage will be determined by root coverage divided by initial recession, multiplied by 100


Secondary Outcome Measures :
  1. Tissue thickness [ Time Frame: 4 months ]
    The thickness of the gingival tissue will be



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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:

A. At least one Miller Class I or II mucogingival defect ≥ 3 mm (Miller 1985).

B. The mucogingival defect must be on a non-molar tooth.

C. Patients must be ≥ 18 years of age.

Exclusion Criteria:

A. Patients with debilitating systemic or diseases that significantly affect the periodontium.

B. Patients with a known allergy to any of the materials that will be used in the study, including systemic antibiotics (tetracycline and doxycycline).

C. Patients requiring antibiotic prophylaxis.

D. Root surface restorations at the site of recession.

E. No detectable CEJ

F. Patients who fail to maintain oral hygiene levels of at least 80% plaque free surfaces.

G. Patients who are pregnant or lactating.

H. Patients who use tobacco products (smoking or smokeless tobacco).

I. Patients with alcohol abuse problems.

J. Patients undergoing long-term steroid therapy.

K. History of previous root coverage procedures, graft or GTR, on the test teeth.

L. Patients who fail to complete the informed consent form


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): NCT03582995


Contacts
Contact: Jodie Lusby, DMD 859-816-2701 jblusb01@louisville.edu
Contact: Katrine Andreasen, DMD 502-939-7614 katrine.andreasen@louisville.edu

Locations
United States, Kentucky
Graduate Periodontics, UofL School of Dentistry
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Henry Greenwell, DMD, MS University of Louisville

Responsible Party: Henry Greenwell, Program Director, University of Louisville
ClinicalTrials.gov Identifier: NCT03582995     History of Changes
Other Study ID Numbers: 18.0467
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 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

Additional relevant MeSH terms:
Gingival Recession
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy