Efficacy and Safety Evaluation Study of Implants With Periodontal Ligament
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOrganTech, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Periodontal Ligament-Integrated Implant
DeviceThe 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.
Treatment groups
6 Participants
are divided into 1 treatment groupGroup A: Periodontal Ligament-Integrated Implant PlacementExperimental treatment 1 intervention
Trial outcomes
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).
Time frame
24 weeks after implantationSecondary outcomes
1
Rate of integration into the jawbone Over Time
Presence or absence of integration into the jawbone (9 weeks postoperatively, 18 weeks postoperatively, 48 weeks postoperatively).
Time frame
9, 18, and 48 weeks postoperatively2
Periodontal Pocket Depth
Periodontal pocket depth (mm) at Baseline (Visit 1 - approximatelly 11 weeks preoperative), and at 9, 18, 24, and 48 weeks postoperatively.
Time frame
Baseline (approximately 11 weeks preoperative) to 48 weeks postoperatively3
Physiological Instability (PT value) With Fixation
Physiological instability (periotest value) immediately after surgery, 1 week after surgery, 3 weeks after surgery, 7 weeks after surgery, 9 weeks after surgery, 10 weeks after surgery, 14 weeks after surgery, 18 weeks after surgery, 24 weeks after surgery, and 36 weeks after surgery with fixation.
Time frame
Immediately after surgery to 36 weeks postoperatively4
Physiological Tooth Mobility (PT Value) Without Fixation
Physiological tooth mobility (periotest value) without fixation, measured at Baseline (approximately 11 weeks preoperatively) (Visit 3), and at 9, 18, 24, 36, and 48 weeks postoperatively, as well as clinical tooth mobility (Miller classification) assessed by the surgeon.
Time frame
Baseline (approximately 11 weeks preoperative) to 48 weeks postoperativelyOther outcomes
1
Oral Related QOL (Japan Prosthodontic Society Questionnaire)
Oral related QOL (Japan Prosthodontic Society questionnaire), assessed at Baseline (approximately 11 weeks preoperatively) (Visit 3), and at 18 and 48 weeks postoperatively.
Time frame
Baseline (approximately 11 weeks preoperatively) to 48 weeks postoperatively2
Safety Evaluation - Incidence of adverse events and device-related defects
Incidence of diseases and frequency of defects.
Time frame
From implantation to 48 weeks postoperativelySponsors and contacts
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Source ClinicalTrials.gov