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Completed

NCT Number: NCT03582995

Root Coverage With Acellular Dermal Matrix and Bovine Derived Osseous

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Graduate Periodontics, UofL School of Dentistry

Louisville, Kentucky, 40202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flap Surgery for root coverage with Alloderm and xenograft

Procedure

A coronally positioned FLAP technique with AlloDerm® GBR and osseous xenograft will be used for root coverage

Tunnel Surgery for root coverage with Alloderm and xenograft

Procedure

A coronally positioned TUNNEL technique with AlloDerm® GBR and osseous xenograft will be used for root coverage.

Primary outcomes

  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 outcomes

  1. Tissue thickness

    Time frame: 4 months

    The thickness of the gingival tissue will be

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Official study title

Root Coverage With Acellular Dermal Matrix and Bovine Derived Osseous Xenograft Using Either a Coronally Positioned Tunnel or Coronally Positioned Flap

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 11, 2018
Registry last updated
Jun 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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