Non-Inferiority of Fibroguide Collagen Membrane Compared to Autologous Connective Tissue Graft for Coverage of Multiple Adjacent Recession. Multicenter Trial.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMaurizio Tonetti

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Volume stable collagen matrix
  • Autologous Connective Tissue Graft from the Hard Palate

Treatment groups

160 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Maurizio Tonetti

Lead sponsor

The European Research Group on Periodontology (ERGOPerio)

Sponsor institution

University of Florence

Collaborator

Universitat Internacional de Catalunya

Collaborator