This study deals with coverage of multiple denuded roots. The current standard treatment requires surgical correction and uses soft tissue taken from the roof of the mouth to enhance results. The hypothesis of this trial is that a synthetic collagen matrix (called Fibrogide) can be used to replace soft tissue taken from the subject. If the collagen matrix will prove to be equally as effective as the patient own tissue, it will be possible to avoid a more extensive surgery and decrease pain and discomfort.
Male and female, 18 to 70 years of age, with a minimum of two adjacent teeth with gingival recession (at least one with a depth ≥ 3 mm - RT1 or RT2 with 2 mm or less of interdental periodontal attachment loss) in anterior and premolar teeth in the maxilla and requiring surgical intervention, without medical contraindications to elective surgery. In case of recessions on five or more adjacent teeth, the teeth at the external sides will not be included in the study.
At least 2 mm marginal keratinized tissue width and irrespective of soft tissue thickness prior therapy. The study should involve treatment naïve patients in terms of root coverage procedures. Prior therapy should include treatment of gingival inflammation, if present, instructions in non-traumatic oral hygiene, and reconstruction of the cemento-enamel junction with adhesive dental materials in case of cervical abrasion or erosion involving this structure
Evidence of subject ability to achieve good oral hygiene and control gingivitis in the whole of the dentition (FMPS<25% and FMBS<25%)
Ability to understand study procedures and to comply with them for the entire length of the study. Ability and willingness to give written informed consent.
Presence of untreated periodontitis
Persistence of uncorrected gingival trauma from tooth brushing
Interdental attachment loss greater than 2 mm or furcation involvement in the experimental teeth
Presence of less than 2 mm of keratinized tissue width
Parallel
Volume stable collagen matrix
DeviceVolume stable collagen matrix obtained from porcine collagen after proprietary cross-linking by device manufacturer
Autologous Connective Tissue Graft from the Hard Palate
Procedure/SurgeryAutologous connective tissue surgically harvested from the hard palate and transplanted in the area of gingival recession
Root coverage
Difference in reduction in gingival recession (root coverage) between baseline and 12 months
Complete root coverage
Frequency of teeth and subjects with complete coverage of exposed root surface
Time to recovery
Time necessary for remission of post-surgical pain and discomfort
Oral Health Related Quality of Life
Oral Health Impact Profile (OHIP-14) instrument - Scale 0-10 with higher scores indicating a better outcome
Tissue thickness
Marginal soft tissue thickness measured digitally on intraoral scan
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Maurizio Tonetti
Lead sponsor
The European Research Group on Periodontology (ERGOPerio)
Sponsor institution
University of Florence
Collaborator
Universitat Internacional de Catalunya
Collaborator
