Collagen Matrix With and Without Enamel Matrix Derivative

Porcine Collagen Matrix With and Without Enamel Matrix Derivative for the Treatment of Gingival Recession Defects

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 addition of enamel matrix derivative (EMD) in the treatment of Miller Class I, II, or predictable class III recession defects. One defect will receive CM + CAF + EMD (Experimental), while the other will receive CM + CAF (Control) alone. The treatment of 60 similarly sized Miller class I, II, or predictable class III recession defects on single-rooted teeth in 30 subjects using CM + CAF + EMD or CM + CAF alone will be evaluated. The subjects will be in good health, non-smokers, periodontally healthy with good oral hygiene and have no contraindications to periodontal surgery. Paired, similar sized defects on single-rooted teeth will be in the same subject and measure within 2mm of each other. One defect will be randomly assigned as the test group using CM + CAF + EMD, and the other as the control group using only CM + CAF. Clinical measurements will be made using a UNC-15 periodontal probe by calibrated, board certified periodontists and will include: probing depth (PD), clinical attachment level (CAL), vertical recession (RD), and width of keratinized tissue (KT). Percent root coverage (%RC) will be calculated. The measurements will be used to evaluate surgical outcome. Surgical outcome will also be assessed using stone models. All measurements will be taken at baseline (on the day of the surgery) and 3 and 6 months post-surgery for comparison.

Study Overview

• Status: Unknown
• Conditions: Gingival Recession
• Intervention / Treatment: Biological: enamel matrix derivative; Device: Porcine collagen matrix

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20814
      • Recruiting
      • Walter Reed NMMC
      • Contact: Ryan A Kaye, DMD; Phone Number: 301-295-2127; Email: ryan.a.kaye.mil@mail.mil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants must meet health eligibility requirements and not have any conditions that will exclude them from the study (see exclusion criteria below). Females of reproductive age will be asked to submit urine samples for pregnancy testing prior to surgery. Urine HCG tests will be conducted in the Department of Periodontics in accordance with WRNNMC Bethesda Point of Care Testing Procedures. Pregnant females will be excluded from this study in accordance with standard of care (periodontal surgery is routinely deferred during pregnancy).

Description

Inclusion Criteria:

• 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 Criteria:

• 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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in gingival recession using conventional measurements	Change in gingival recession measurements from baseline to 6 months	Baseline to 6 months
Change in root coverage using digital analysis	Assessment of surgical outcome by optically scanning stone models captured at baseline to 6 months post-surgery. The digital files will be aligned using global registration and GR recorded by measuring the distance from cemento-enamel junction to the height of the marginal gingiva using computer software. % RC will be calculated by comparing GR at the various times.	Baseline to 6 months
Change in Probing Depths	Change in Probing Depthmeasurements from baseline to 6 months	Baseline to 6 months
Change in Clinical Attachment Levels	Change in Clinical Attachment Levels measurements from baseline to 6 months	Baseline to 6 months
Change in Keratinized Tissue	Change in Keratinized Tissue measurements from baseline to 6 months	Baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of digital vs. conventional measurement	Compare conventional and digital change in gingival recession to assess the two modalities treatment outcomes	Baseline to 6 months

Collaborators and Investigators

• Sponsor: Walter Reed National Military Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ANTICIPATED): December 30, 2020
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: March 1, 2018
• First Submitted That Met QC Criteria: March 9, 2018
• First Posted (ACTUAL): March 16, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 1, 2019
• Last Update Submitted That Met QC Criteria: June 27, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Gingival Recession; Enamel Matrix Derivative; Porcine Collagen Matrix
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: WRNMMC-2017-0123

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No