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Efficacy and Safety Evaluation Study of Implants With Periodontal Ligament
Sponsor: OrganTech, Inc.
Summary
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.
Official title: Evaluation of the Efficacy and Safety of Periodontal Ligament Integrated Implants Via Residual Periodontal Ligament Tissue in Extraction Sockets
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
6
Start Date
2025-06-20
Completion Date
2027-07
Last Updated
2025-12-24
Healthy Volunteers
No
Interventions
Periodontal Ligament-Integrated Implant
The investigational device is a periodontal ligament-integrated implant designed for immediate placement into a tooth extraction socket. Unlike conventional osseointegrated implants, this device utilizes residual periodontal ligament tissue to establish functional attachment and physiological integration with the alveolar bone. The implant-abutment assembly is stabilized with a temporary fixation device for approximately nine weeks, during which integration into the jawbone through the residual periodontal ligament is promoted. After the healing phase, a definitive superstructure is fabricated and placed to allow controlled occlusal loading. Once integration into the jawbone and implant stability are confirmed, the fixation device is removed, and the implant functions independently. The device remains unapproved and is evaluated for safety and efficacy in this study.
Locations (2)
Minami Tohoku Medical Clinic
Kōriyama, Fukushima, Japan
Hillside Akasaka Dental Clinic
Minato-Ku, Tokyo, Japan