Status:
UNKNOWN
Collagen Matrix With and Without Enamel Matrix Derivative
Lead Sponsor:
Walter Reed National Military Medical Center
Conditions:
Gingival Recession
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this prospective, double-blinded, randomized, split-mouth study is to compare the effectiveness of a porcine collagen matrix (CM) and coronally advanced flap (CAF) with or without the a...
Eligibility Criteria
Inclusion
- Age 18 years or over
- Patient will remain in the Capital region for at least 6 months following the surgical procedure for follow up appointments
- Patient must be otherwise periodontally healthy
- Patient must be systemically healthy (ASA class I or II)
- Patient must have no contraindications to periodontal surgery
- Patient must have demonstrated good oral hygiene (plaque index \<1 according to Silness and Löe)
- Paired Miller Class I, II or predictable III recession defects
- Bilateral, facial defects on single-rooted teeth
Exclusion
- Self-reported history of smoking within previous 6 months
- Does not meet any of the preceding criteria
- Female patients who are pregnant or nursing
- Antibiotic medications taken within the last 6 months
- History of mucogingival surgery at the sites of interest
- Poor plaque control (\>25% of sites)
- Those with clinically significant systemic disease, which may affect healing (i.e. uncontrolled diabetes or bone metabolic disease)
- Allergy to chlorhexidine gluconate (Peridex)
- Does not sign study consent or HIPAA forms
- Bleeding complications (e.g. hemophilia)
- Warfarin therapy
- History of osteoporosis or taking bisphosphonate medications
- History of radiation therapy in the head and neck area
- Mobile teeth beyond physiologic mobility
- Facial restorations at the site to be treated
- Recession defects that will require more than one 15x20mm Mucograft (per side)
Key Trial Info
Start Date :
January 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03467802
Start Date
January 1 2019
End Date
December 31 2021
Last Update
July 1 2019
Active Locations (1)
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1
Walter Reed NMMC
Bethesda, Maryland, United States, 20814