Actively Recruiting
Evaluation of the Efficacy and Safety of Periodontal Ligament-Integrated Implants Using Residual Periodontal Ligament Tissue in Extraction Sockets
Led by OrganTech, Inc. · Updated on 2025-12-24
6
Participants Needed
2
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new type of dental implant called a periodontal ligament-integrated implant for adults aged 18 and older who need a single-rooted tooth extracted. This exploratory study aims to assess whether this implant can successfully integrate with the jawbone 24 weeks after placement and if it can restore natural tooth functions such as mobility and sensory feedback while maintaining periodontal health. The implant uses residual periodontal ligament tissue in the extraction socket to promote functional attachment, differing from traditional implants that rely solely on bone integration. Participants will undergo extraction of one single-rooted tooth followed immediately by placement of the investigational implant stabilized with a temporary fixation device. This fixation remains for about nine weeks to allow healing and integration. Afterward, a superstructure is placed for controlled chewing load, and the fixation device is removed once stable integration is confirmed. The study involves multiple follow-up visits over 48 weeks, with ongoing oral care and monitoring. During the study, participants will have dental X-rays, CT scans, and clinical exams to evaluate bone healing, periodontal ligament formation, implant stability, and tooth mobility. Researchers will also measure periodontal pocket depth, pain levels, and assess patient quality of life using oral health questionnaires. Safety and implant performance will be closely monitored, with assessments continuing up to 48 weeks to gather comprehensive data on the implant's biological feasibility, mechanical behavior, and clinical safety.
CONDITIONS
Brief Title
Efficacy and Safety Evaluation Study of Implants With Periodontal Ligament
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with one single-rooted tooth (incisor to premolar) needing extraction due to caries or fracture with healthy periodontal tissue around the root
- Adjacent teeth are natural and have healthy periodontal tissues with no abnormalities on X-rays, CT scans, or mobility tests
- Able to achieve proper occlusion with opposing teeth
- Age 18 years or older at consent
- Provided written consent and able to comply with study visits and procedures
You will not qualify if you...
- Jawbone still growing
- Undergoing orthodontic treatment or wearing retainers after orthodontic treatment
- Multiple missing teeth or edentulous jaw missing multiple occlusal support areas
- Periodontal pockets 4mm or more around the tooth to be extracted or adjacent teeth
- Bacterial infection or acute inflammation such as periodontitis in the tooth to be extracted
- Apical periodontitis in the tooth to be extracted
- Two or more consecutive missing teeth or free-end edentulous space due to extraction
- Target tooth already extracted or difficult to extract
- Not healthy enough for tooth extraction and implant surgery
- Abnormal root morphology or position (curved, tilted, etc.)
- Root size of the tooth too small or malocclusion preventing implant placement
- Open bite
- History of hypersensitivity to implant components
- Alveolar bone resorption at implant site
- Bleeding disorders
- Uncontrolled diabetes
- Contraindication for general oral surgery
- Undergoing radiation or chemotherapy for malignant tumors
- Receiving bisphosphonate therapy
- Currently smoking
- Unable to understand or cooperate with treatment
- Pregnant or possibly pregnant
- Any other condition deemed unsuitable by the investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 9 weeks
Participants undergo tooth extraction followed by immediate placement of a periodontal ligament-integrated implant stabilized with a temporary fixation device to promote healing and integration.
Periodic visits for surgical procedure, suture removal at 3 weeks, and radiographic evaluations during healing
Duration - Up to 15 weeks following initial healing
After the healing phase, a superstructure is fabricated and placed for controlled occlusal loading, and the fixation device is removed once integration and stability are confirmed.
Visits for superstructure placement and fixation removal
Duration - Up to 48 weeks post-implantation
Participants are monitored for implant integration, periodontal attachment formation, bone remodeling, implant mobility, and patient comfort for up to 48 weeks after implantation.
Multiple follow-up visits for clinical, radiographic, and physiological assessments
Trial Site Locations
Total: 2 locations
1
Minami Tohoku Medical Clinic
Kōriyama, Fukushima, Japan
Actively Recruiting
2
Hillside Akasaka Dental Clinic
Minato-Ku, Tokyo, Japan
Actively Recruiting
Research Team
Y
Yoshitake Yamaguchi, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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