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Efficacy and Safety Evaluation Study of Implants With Periodontal Ligament

NCT07302581 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-12-24

No results posted yet for this study

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • OrganTech, Inc.

    lead INDUSTRY

Principal Investigators

  • Shohei Kasugai, PhD · Minami Tohoku Medical Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-20
Primary Completion
2026-12-31
Completion
2027-07-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07302581 on ClinicalTrials.gov