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New treatment option for Soft Tissue Atrophy
Official title Behavioral Comparison of Three Different Graft Materials to Increase Soft Tissue Thickness Around Dental Implants.
ClinicalTrials.gov ID: NCT04766255
What this study is testing
- What it's testing
- The purpose of the study is to compare soft tissue volume changes in terms of volume gain and stability around dental implants and PROMS in cases where a sub-epithelial connective tissue graft (SCTG) from the palate, Porcine collagen matrix (CM) or Porcine Acellular dermal matrix (PADM) is used after 3 and 15 months after implant placement.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Patients referred to Department of Periodontology (CUO) in need of a single implant and need of soft tissue augmentation such as buccal defects, thin...
- The patient must be ≥18 years and able to understand the nature of the proposed surgery and must sign an informed consent.
- The implant must be located between 2 fixed reference points (i.e. clinical crowns).
- Anterior and premolar teeth (from premolar to premolar).
- Enough crestal bone width to leave a minimum thickness of 2mm at the buccal bone plate when placing the implant.
You likely can't join if
- Pregnant or lactation.
- Active periodontal disease.
- Previous soft tissue augmentation in the area.
- Need of guided bone regeneration (GBR) during or after the placement of the implant.
- Heavy smokers (\> 10 cigarettes per day).
- Local or systemic conditions that would interfere with routine periodontal therapy (non-controlled diabetes mellitus, cancer, HIV, Chronic High dose...
See the full eligibility criteria
- Patients referred to Department of Periodontology (CUO) in need of a single implant and need of soft tissue augmentation such as buccal defects, thin biotype, lack of keratinized tissue and aesthetic compromised...
- The patient must be ≥18 years and able to understand the nature of the proposed surgery and must sign an informed consent.
- The implant must be located between 2 fixed reference points (i.e. clinical crowns).
- Anterior and premolar teeth (from premolar to premolar).
- Enough crestal bone width to leave a minimum thickness of 2mm at the buccal bone plate when placing the implant.
- Palate must have ≥2mm of thickness at premolar area.
- Full mouth plaque and bleeding score \<20%.
- Pregnant or lactation.
- Active periodontal disease.
- Previous soft tissue augmentation in the area.
- Need of guided bone regeneration (GBR) during or after the placement of the implant.
- Heavy smokers (\> 10 cigarettes per day).
- Local or systemic conditions that would interfere with routine periodontal therapy (non-controlled diabetes mellitus, cancer, HIV, Chronic High dose steroid therapy, bone metabolic diseases, radiation, immunosuppressive...
- Allergy to non-steroidal anti-inflammatory drugs.
- Patients taking medications that cause gingival enlargement.
The study team makes the final eligibility decision.
Where it's taking place
- Sant Cugat del Vallès, 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 and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sant Cugat del Vallès, 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.