Root Coverage With Acellular Dermal Matrix & Bovine Derived Osseous

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03582995
Study type	Interventional
Source	University of Louisville
Contact
Status	Completed
Phase	N/A
Start date	October 23, 2018
Completion date	April 30, 2021

View Details

See also
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Completed	`NCT03163654` - Novel Porcine Dermal Matrix in the Treatment of Multiple Adjacent Gingival Recessions	N/A
Not yet recruiting	`NCT05470660` - Coronally Advanced Flap With Alloderm Versus Coronally Advanced Flap With Micro-needling on RT1 Gingival Recession	N/A
Enrolling by invitation	`NCT03660566` - Use of Leucocyte- and Platelet-rich Fibrin Membranes in Single Implant	N/A
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Not yet recruiting	`NCT06166017` - Lingual Keratinized Tissue in Fully Edentulous Patients and Its Impact on Implant Health
Not yet recruiting	`NCT05823415` - Clinical Evaluation of Laterally Closed Tunnel Technique Versus Coronally Advanced Flap Combined With Connective Tissue Graft for the Treatment of Isolated RT2 Gingival Recession	N/A
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Root Coverage With Acellular Dermal Matrix and Bovine Derived Osseous

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms