BridgeMD
Tests treatment safety and results for Tooth Extraction
Official title Efficacy and Safety Evaluation Study of Implants With Periodontal Ligament
ClinicalTrials.gov ID: NCT07302581
What this study is testing
- What it's testing
- The goal of this clinical trial is to evaluate the efficacy and safety of periodontal ligament-integrated implants placed via residual periodontal ligament tissue in extraction sockets in adult patients (aged 18 and older) requiring extraction of a single-rooted tooth. The main questions it aims to answer are: Does the periodontal ligament-integrated implant achieve stable integration with the jawbone at 24 weeks after placement?
- Time commitment: about 48 weeks
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
You may be able to join if
- Patients who have only one single-rooted tooth, from the upper or lower incisors to the premolars, which require extraction due to caries or a...
- The teeth adjacent to the tooth to be extracted are natural teeth with healthy periodontal tissues, and no abnormalities are found in dental X-rays...
- Patients aged 18 years or older at the time of consent.
- Patients who have provided written consent to participate in this clinical study and are able to comply with study visits and procedures.
You likely can't join if
- Patients whose jawbone is still growing.
- Patients undergoing orthodontic treatment or wearing retainers after orthodontic treatment.
- Patients with multiple missing teeth or an edentulous jaw where multiple occlusal support areas of the remaining teeth are missing.
- Patients who have periodontal pockets of 4mm or more around the root of the tooth to be extracted or the teeth adjacent to the tooth to be extracted.
- Patients with bacterial infection or acute inflammation such as periodontitis in the tooth to be extracted.
- Patients with apical periodontitis in the tooth to be extracted.
See the full eligibility criteria
Who can join
- Patients who have only one single-rooted tooth, from the upper or lower incisors to the premolars, which require extraction due to caries or a fracture, and who have healthy periodontal tissue remaining around the root...
- The teeth adjacent to the tooth to be extracted are natural teeth with healthy periodontal tissues, and no abnormalities are found in dental X-rays, CT scans, periodontal pocket examinations, or physiological mobility...
- Patients aged 18 years or older at the time of consent.
- Patients who have provided written consent to participate in this clinical study and are able to comply with study visits and procedures.
What rules you out
- Patients whose jawbone is still growing.
- Patients undergoing orthodontic treatment or wearing retainers after orthodontic treatment.
- Patients with multiple missing teeth or an edentulous jaw where multiple occlusal support areas of the remaining teeth are missing.
- Patients who have periodontal pockets of 4mm or more around the root of the tooth to be extracted or the teeth adjacent to the tooth to be extracted.
- Patients with bacterial infection or acute inflammation such as periodontitis in the tooth to be extracted.
- Patients with apical periodontitis in the tooth to be extracted.
- Patients who will have two or more consecutive missing teeth or free-end edentulous space due to the extraction of the target teeth.
- Patients who have already had the target tooth extracted.
- Patients for whom extraction of the target tooth is expected to be difficult.
- Patients who are not healthy enough to undergo the tooth extractions and surgical procedures required for implant treatment using this product.
- Patients with abnormal root morphology or position (curved, tilted, etc.) of the tooth to be extracted.
- Patients in whom this product cannot be implanted due to the root size of the tooth to be extracted (root length less than 10 mm, root diameter at the cervical part less than 5.4 mm in long diameter, less than 3.4 mm in...
- Patients with open bite.
- Patients with a history of hypersensitivity to the components of this product or similar products.
- Patients with alveolar bone resorption in the area where the implant is to be placed.
- Patients with bleeding disorders. (There is a risk of abnormal bleeding and poor healing of the surgical site).
- Patients with uncontrolled diabetes. (There is a risk of poor healing of the surgical site and increased susceptibility to infection.)
- Patients for whom general oral surgery is contraindicated. (There is a risk that the invasive procedure may worsen the disease, cause recurrence of preexisting conditions, or result in poor healing of the surgical site...
- Patients who undergo radiation therapy or chemotherapy due to malignant tumors, etc. (There is a risk that the surgical site may not heal properly.)
- Patients receiving bisphosphonate therapy.
- Patients who currently smoke.
- Patients who do not understand or cooperate with the treatment.
- Pregnant patients or patients who may be pregnant.
- Any other patient deemed unsuitable for participation in this study by the principal investigator (or co-investigator).
The study team makes the final eligibility decision.
Where it's taking place
- Kōriyama, Fukushima, Japan
- Minato-Ku, Tokyo, Japan
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 study runs about 48 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kōriyama, Fukushima, Japan; Minato-Ku, Tokyo, Japan. 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.