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Tests treatment safety and results for Bone Regeneration
Official title Evaluation of Performance, Safety and Benefit of the Wishbone HA as Bone Graft Substitute, a Pre-market Clinical Investigation
ClinicalTrials.gov ID: NCT06383377
What this study is testing
- What it's testing
- This investigation is a pre-market, prospective, multi-center, randomized, single blinded, parallel controlled clinical investigation performed in at least 5 clinical centers for confirmatory purposes of the use of WHA as intended in the filling of extraction sockets to enhance preservation of the alveolar socket.
- 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 80. Healthy volunteers may be eligible.
You may be able to join if
- The subject signed the informed consent form;
- The subject is ≥ 18 and ≤ 80 years old at surgery;
- The subject is in need of a tooth extraction prior to implant placement;
- All four bony walls are preserved after extraction;
- Minimum 8mm height of bone;
You likely can't join if
- Subject with an acute infection (abscess) at the surgical site;
- Subject with untreated periodontitis or periodontal disease;
- Subject with autoimmune diseases or people that had received or were currently receiving treatment with antiresorptive drugs (e.g., bisphosphonates)...
- Subject who is pregnant or breastfeeding;
- people is a heavy smoker (\>10 cigarettes a day);
- Subject with an inability to conduct basic oral hygiene (poor oral hygiene and motivation);
See the full eligibility criteria
- The subject signed the informed consent form;
- The subject is ≥ 18 and ≤ 80 years old at surgery;
- The subject is in need of a tooth extraction prior to implant placement;
- All four bony walls are preserved after extraction;
- Minimum 8mm height of bone;
- Minimum 7mm thickness of lingual vestibular;
- The subject is willing and able to comply with all investigation related procedures (such as exercising oral hygiene and attending all follow-up visits);
- Full-mouth bleeding score (FMBS) lower than 25%;
- Full-mouth plaque score (FMPI) lower than 25%.
- Subject with an acute infection (abscess) at the surgical site;
- Subject with untreated periodontitis or periodontal disease;
- Subject with autoimmune diseases or people that had received or were currently receiving treatment with antiresorptive drugs (e.g., bisphosphonates), or steroid therapy;
- Subject who is pregnant or breastfeeding;
- people is a heavy smoker (\>10 cigarettes a day);
- Subject with an inability to conduct basic oral hygiene (poor oral hygiene and motivation);
- Subject with metabolic diseases (diabetes, hyperparathyroidism, osteomalacia);
- Subject with severe renal dysfunction and severe liver disease;
- Subject with known severe osteoporosis;
- Subject with multiple sclerosis and/or acromegaly;
- Subject follows radiotherapy;
- Subject with psychiatric disorders or under substance abuse (drug or alcohol);
- Subject who participates in other clinical trials interfering with the present protocol;
- Mucosal diseases in the areas to be treated.
The study team makes the final eligibility decision.
Where it's taking place
- Louvain-la-Neuve, Brabant Wallon, Belgium
- Aubel, Liège, Belgium
- Chaudfontaine, Liège, Belgium
- Liège, Belgium
- Namur, Belgium
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 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Louvain-la-Neuve, Brabant Wallon, Belgium; Aubel, Liège, Belgium; Chaudfontaine, Liège, Belgium; Liège, Belgium; Namur, Belgium. 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.