Efficacy and Safety Evaluation Study of Implants With Periodontal Ligament

NCT07302581 | Recruiting

• 2 other identifiers: OrgT-CPS-001jRCTs022240055
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Tooth Extraction; Tooth Fractures; Dental Caries; Tooth Dislocation

Keywords

Root Fracture; Crown Fracture; Tooth Mobility; Carious Tooth; Extraction site healing

Outcome Measures

Primary Outcomes (1)

• Rate of integration into the jawbone at 24 Weeks Post-Implantation

  Presence or absence of integration with the jawbone at 24 weeks postoperatively (Rate of integration into the jawbone).

  24 weeks after implantation

Secondary Outcomes (7)

• Rate of integration into the jawbone Over Time

  9, 18, and 48 weeks postoperatively

• Periodontal Pocket Depth

  Baseline (approximately 11 weeks preoperative) to 48 weeks postoperatively

• Physiological Instability (PT value) With Fixation

  Immediately after surgery to 36 weeks postoperatively

• Physiological Tooth Mobility (PT Value) Without Fixation

  Baseline (approximately 11 weeks preoperative) to 48 weeks postoperatively

• Perceptual and Sensory Evaluation (Pain)

  Baseline (approximately 11 weeks preoperatively) to 48 weeks postoperatively

Other Outcomes (2)

• Oral Related QOL (Japan Prosthodontic Society Questionnaire)

  Baseline (approximately 11 weeks preoperatively) to 48 weeks postoperatively

• Safety Evaluation - Incidence of adverse events and device-related defects

  From implantation to 48 weeks postoperatively

Study Arms (1)

Periodontal Ligament-Integrated Implant Placement

EXPERIMENTAL

Participants undergo preoperative evaluation, including oral examination, CT imaging, and impressions for implant simulation and fabrication. After eligibility confirmation, a single-rooted tooth is extracted using minimally invasive techniques to preserve residual periodontal ligament tissue. A periodontal ligament-integrated implant with an abutment and fixation is immediately placed into the extraction socket and stabilized with dental cement. Sutures are removed after three weeks. The implant remains unloaded for about nine weeks for healing and integration into the jawbone, with periodic radiographic evaluation. A superstructure is then fabricated and placed for controlled occlusal loading. Once integration into the jawbone via regenerated periodontal ligament is confirmed, the fixation is removed and the implant functions independently. Oral care is maintained throughout the study.

Device: Periodontal Ligament-Integrated Implant

Interventions

Periodontal Ligament-Integrated Implant DEVICE

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.

Periodontal Ligament-Integrated Implant Placement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• OrganTech, Inc.: lead

Study Sites (2)

Minami Tohoku Medical Clinic

Kōriyama, Fukushima, Japan

RECRUITING

Hillside Akasaka Dental Clinic

Minato-Ku, Tokyo, Japan

RECRUITING

MeSH Terms

Conditions

Tooth Fractures; Dental Caries; Tooth Avulsion; Tooth Mobility

Condition Hierarchy (Ancestors)

Tooth Injuries; Tooth Diseases; Stomatognathic Diseases; Wounds and Injuries; Tooth Demineralization; Periodontal Diseases; Mouth Diseases

Study Officials

• Shohei Kasugai, PhD

  Minami Tohoku Medical Clinic

  STUDY DIRECTOR

Central Study Contacts

Yoshitake Yamaguchi, PhD

CONTACT

＋８１-３-５８５９-５７６１; yoshitake.yamaguchi@organ-tech.jp

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 24, 2025
• Study Start: June 20, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2)