Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07302581

Efficacy and Safety Evaluation Study of Implants With Periodontal Ligament

Led by OrganTech, Inc. · Updated on 2025-12-24

6

Participants Needed

2

Research Sites

105 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Efficacy and Safety Evaluation Study of Implants With Periodontal Ligament

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older at the time of consent
  • Have only one single-rooted tooth (from upper or lower incisors to premolars) requiring extraction due to caries or fracture
  • Have healthy periodontal tissue remaining around the root of the tooth to be extracted
  • Adjacent teeth are natural with healthy periodontal tissues and no abnormalities on dental X-rays, CT scans, periodontal pocket exams, or mobility tests
  • Able to achieve proper occlusion with opposing teeth
  • Provided written consent and can comply with study visits and procedures
Not Eligible

You will not qualify if you...

  • Jawbone is still growing
  • Undergoing orthodontic treatment or wearing retainers after orthodontic treatment
  • Multiple missing teeth or edentulous jaw with missing occlusal support
  • Periodontal pockets of 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
  • Expected to have two or more consecutive missing teeth or free-end edentulous space after extraction
  • Target tooth already extracted
  • Extraction of the target tooth expected to be difficult
  • Not healthy enough for tooth extraction or implant surgery
  • Abnormal root morphology or position (curved, tilted, etc.) of the tooth
  • Implant cannot be placed due to root size or malocclusion
  • Open bite
  • History of hypersensitivity to components of this product or similar products
  • Alveolar bone resorption at implant site
  • Bleeding disorders
  • Uncontrolled diabetes
  • Contraindications for general oral surgery
  • Receiving radiation therapy or chemotherapy for malignant tumors
  • Receiving bisphosphonate therapy
  • Current smoker
  • Does not understand or cooperate with treatment
  • Pregnant or may be pregnant
  • Any other condition deemed unsuitable by the investigator

AI-Screening

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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

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Research Team

Y

Yoshitake Yamaguchi, PhD

CONTACT

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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