An observational study in Gingival Recession, sponsored by Walter Reed National Military Medical Center. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-01.
Sponsored by Walter Reed National Military Medical Center · Observational
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.
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).
Exclusion Criteria:
Enamel matrix derivative (EMD), sold under the brand name Emdogain®, is an amelogenin derivative of embryonal porcine enamel and is FDA approved for application to root surfaces to treat recession defects. Amelogenins comprise the majority of the proteins in EMD while others such as tuftelin, ameloblastin and amelin make up the remainder. EMD is thought to mimic the role of proteins crucial to cementogenesis and root development, which may promote new gingival attachment to exposed roots. The properties of EMD may favor early healing of the soft tissue and stimulate angiogenesis.
Also known as: Emdogain®
Mucograft® is a bi-layered grafting material composed of Type I and III collagen. It is derived from veterinary certified pigs, sterilized by gamma irradiation and has a low antigenicity in conjunction with good biocompatibility. The material is approximately 2.5-5mm thick and is indicated for root coverage, increasing keratinized tissue, covering of implants placed immediately and alveolar ridge reconstruction. A compact outer layer contributes to protection, structure and allows for better control during suturing; while the inner layer is thick, porous and spongy in nature, providing a suitable environment for early vascularization and promotion of cellular in-growth.
Also known as: Mucograft®
Change in gingival recession using conventional measurements
Change in gingival recession measurements from baseline to 6 months
Time frame: 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.
Time frame: Baseline to 6 months
Change in Probing Depths
Change in Probing Depthmeasurements from baseline to 6 months
Time frame: Baseline to 6 months
Change in Clinical Attachment Levels
Change in Clinical Attachment Levels measurements from baseline to 6 months
Time frame: Baseline to 6 months
Change in Keratinized Tissue
Change in Keratinized Tissue measurements from baseline to 6 months
Time frame: Baseline to 6 months
Comparison of digital vs. conventional measurement
Compare conventional and digital change in gingival recession to assess the two modalities treatment outcomes
Time frame: Baseline to 6 months
This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Walter Reed National Military Medical Center