Non-Inferiority of Fibroguide Collagen Membrane Compared to Autologous Connective Tissue Graft for Coverage of Multiple Adjacent Recession. Multicenter Trial.
Connective Tissue Graft vs Volume Stable Collagen Matrix (Geistlich Fibro-Gide®) for Coverage of Multiple Gingival Recession Defects in Combination With Coronally Advanced Flap (CAF) Randomized Multicenter Controlled Clinical Trial Assessing Non-Inferiority in Root Coverage
Maurizio Tonetti
160 participants
Jul 12, 2015
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria4
- 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.
Exclusion Criteria17
- 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
- Presence of severe tooth malposition, rotation or clinically significant super-eruption
- Self reported current smoking exceeding 10 cigarettes/day or pipe or cigar smoking
- Rheumatoid arthritis or known sensitization to collagen based medical products.
- Presence of medical contraindications to elective surgery
- Participation in another interventional clinical trial
- Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Inability or unwillingness of individual to give written informed consent.
- Uncontrolled diabetes mellitus
- Allergy to collagen
- Pregnancy or lactation or sexually active female subjects who are of childbearing potential and who are not using hormonal or barrier methods of birth control (e.g., oral or parenteral contraceptives, diaphragm plus spermicide, condoms).
- Radiotherapy
- immunosuppressive therapy
- chronic steroid therapy (inhaler or systemic).
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Interventions
Volume stable collagen matrix obtained from porcine collagen after proprietary cross-linking by device manufacturer
Autologous connective tissue surgically harvested from the hard palate and transplanted in the area of gingival recession
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07083050