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Compares treatment options for Gingival Recession, Plastic Surgery
Official title Non-Inferiority of Fibroguide Collagen Membrane Compared to Autologous Connective Tissue Graft for Coverage of Multiple Adjacent Recession. Multicenter Trial.
ClinicalTrials.gov ID: NCT07083050
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- At least 2 mm marginal keratinized tissue width and irrespective of soft tissue thickness prior therapy. The study should involve treatment naïve...
- 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...
You likely can't join if
- 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
See the full eligibility criteria
- 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...
- 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...
- 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
- 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 treatment 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 people 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...
- Radiotherapy
- immunosuppressive therapy
- chronic steroid therapy (inhaler or systemic).
The study team makes the final eligibility decision.
Where it's taking place
- Florence, Italy
- Barcelona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Florence, Italy; Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.