Periodontal ligament-integrated implant to restore tooth-like mobility and sensation
Evaluation of the Efficacy and Safety of Periodontal Ligament Integrated Implants Via Residual Periodontal Ligament Tissue in Extraction Sockets
This trial will try a new dental implant that uses leftover periodontal ligament tissue to replace a single-rooted tooth in adults and see if it restores natural tooth movement and feeling.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | OrganTech, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Kōriyama, Fukushima and 1 other locations) |
| Trial ID | NCT07302581 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, single-arm exploratory study in which a periodontal ligament (PDL)-integrated implant is placed immediately into the extraction socket of a single-rooted tooth using residual PDL tissue to promote a PDL-like attachment. The implant-abutment assembly is temporarily fixed for about 9 weeks, then progressively loaded with a superstructure, and participants are followed for up to 48 weeks with clinical exams and dental imaging. The primary interest is whether the implant achieves stable integration by 24 weeks and can reproduce physiological mobility and sensory function while maintaining periodontal health. Approximately six adult participants will be enrolled across two Japanese dental centers.
Who should consider this trial
Good fit: Adults (18+) who need extraction of a single-rooted tooth (incisor to premolar) and have healthy residual periodontal tissue around that tooth and healthy adjacent natural teeth are the intended candidates.
Not a fit: Patients with growing jaws, those undergoing orthodontic treatment or wearing retainers, or individuals with multiple missing teeth or an edentulous jaw are unlikely to be eligible or to benefit from this approach.
Why it matters
Potential benefit: If successful, this approach could restore tooth-like mobility and mechanosensory feedback, improving function and compatibility with adjacent natural teeth compared with conventional bone-anchored implants.
How similar studies have performed: The PDL-integrated implant concept is novel with limited clinical data; preclinical work and a few early reports suggest feasibility, but robust clinical success has not yet been established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 of the tooth to be extracted. * 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 tests. Also, patients should be able to achieve proper occlusion with opposing teeth. * 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. Exclusion Criteria: * 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 short diameter) or malocclusion. * 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 postoperatively.) * 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).
Where this trial is running
Kōriyama, Fukushima and 1 other locations
- Minami Tohoku Medical Clinic — Kōriyama, Fukushima, Japan (Recruiting)
- Hillside Akasaka Dental Clinic — Minato-Ku, Tokyo, Japan (Recruiting)
Study contacts
- Study coordinator: Yoshitake Yamaguchi, PhD
- Email: yoshitake.yamaguchi@organ-tech.jp
- Phone: ＋８１-３-５８５９-５７６１
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.