title: Living cellular construct for increasing the width of keratinized gingiva: results from a randomized, within-patient, controlled trial.
abstract: BACKGROUND
  The standard of care for increasing keratinized gingiva adjacent to teeth that do not require root coverage is the free gingival graft (FGG). A pilot study indicated that the use of a living cellular construct (LCC) could be effective in this clinical scenario.
  
  
  METHODS
  A pivotal, multicenter, randomized, within-patient, controlled, open-label trial was conducted (N = 96 patients). After removing the mucosa and keratinized gingiva from the test site, either an LCC or FGG was applied. The primary efficacy endpoint was the ability of the LCC to regenerate ≥2 mm keratinized gingiva at 6 months. Secondary measures were the same color and texture as the adjacent tissue, a 1-mm width of keratinized gingiva at 6 months, patient treatment preference, surgical site sensitivity at 1 week, and patient-reported pain after 3 days. Safety was assessed by reports of adverse events.
  
  
  RESULTS
  At 6 months, the LCC regenerated ≥2 mm of keratinized gingiva in 95.3% of patients (81 of 85 patients; P <0.001 versus a 50% predefined standard). As expected, the FGG generated more keratinized gingiva than the LCC (4.57 ± 1.0 mm versus 3.2 ± 1.1 mm, respectively). The gingiva regenerated with the LCC matched the color and texture of the adjacent gingiva. All patients achieved ≥1 mm keratinized gingiva with the LCC treatment by 6 months, and more patients preferred treatment with the LCC than with the FGG. No difference in sensitivity or pain was noted between the treatments. The treatments were well tolerated, and reported adverse events were typical for this type of periodontal surgery.
  
  
  CONCLUSIONS
  The use of an LCC may provide a safe and effective therapy for augmenting the zone of keratinized gingiva.
authors.affiliation: Private practice, Houston, TX 77063, USA. mkmperio@swbell.net
authors.forename: Michael K
authors.initials: MK
authors.lastname: McGuire
authors.forename: E Todd
authors.initials: ET
authors.lastname: Scheyer
authors.forename: Marc L
authors.initials: ML
authors.lastname: Nevins
authors.forename: Rodrigo
authors.initials: R
authors.lastname: Neiva
authors.forename: David L
authors.initials: DL
authors.lastname: Cochran
authors.forename: James T
authors.initials: JT
authors.lastname: Mellonig
authors.forename: William V
authors.initials: WV
authors.lastname: Giannobile
authors.forename: Damien
authors.initials: D
authors.lastname: Bates
mesh_terms: D000328:Adult; D000368:Aged; D003094:Collagen; D005260:Female; D005347:Fibroblasts / Q000637:transplantation; D005500:Follow-Up Studies; D005881:Gingiva / Q000378:metabolism / Q000502:physiology / Q000637:transplantation; D005889:Gingival Recession / Q000601:surgery*; D005893:Gingivoplasty / Q000379:methods*; D006133:Growth Substances / Q000096:biosynthesis; D006801:Humans; D057194:Intention to Treat Analysis; D015603:Keratinocytes / Q000378:metabolism / Q000637:transplantation*; D008297:Male; D008875:Middle Aged; D057240:Patient Preference; D061214:Patient Safety; D010858:Pigmentation; D011446:Prospective Studies; D012038:Regeneration; D023822:Tissue Engineering / Q000379:methods*; D054457:Tissue Scaffolds; D055815:Young Adult
chemical_list: D006133:Growth Substances; D003094:Collagen