Efficacy and Safety Evaluation Study of Implants With Periodontal Ligament

Recruiting now · Not applicable

Conditions studied: Tooth Extraction, Tooth Fractures, Dental Caries, Tooth Dislocation

In brief

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? * Can this implant reproduce physiological tooth mobility and sensory function similar to natural teeth while maintaining periodontal health? This is a multicenter, single-arm, exploratory study with approximately six participants. Participants will: * Undergo tooth extraction of one single-rooted tooth that meets eligibility criteria. * Receive immediate placement of a periodontal ligament-integrated implant into the extraction socket. * Attend scheduled follow-up visits over 48 weeks for assessments including: * Dental X-rays and clinical examinations to evaluate bone healing, periodontal ligament formation, and implant stability. * Measurements of tooth mobility, pocket depth, and pain levels. * Quality of life assessments using a standardized oral health questionnaire. Researchers will monitor participants for implant integration, safety outcomes, and physiological function restoration over the study period.

Key facts

Study ID

NCT07302581

Run by

OrganTech, Inc.

People needed

6

Starts

2025-06-20

Expected to finish

2027-07-01

Last updated by the study team

2025-12-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 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.

You may not qualify 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.
• 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 it is running

• Minami Tohoku Medical Clinic — Kōriyama, Fukushima, Japan (enrolling)
• Hillside Akasaka Dental Clinic — Minato-Ku, Tokyo, Japan (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.