Tooth ExtractionNCT07302581
Efficacy and Safety Evaluation Study of Implants With Periodontal Ligament
A study testing Periodontal Ligament-Integrated Implant in people with Tooth Extraction and Tooth Fractures, run by OrganTech, Inc. at 2 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Extraction, Tooth Fractures, Dental Caries
- What is being tested?
- Periodontal Ligament-Integrated Implant
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesJapan
- Study dates
- 20 Jun 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 24Show fewer
- 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.
- Patients with bleeding disorders. (There is a risk of abnormal bleeding and poor healing of the surgical site).
- Patients with uncontrolled diabetes. (There is a risk of poor healing of the surgical site and increased susceptibility to infection.)
- Patients for whom general oral surgery is contraindicated. (There is a risk that the invasive procedure may worsen the disease, cause recurrence of preexisting conditions, or result in poor healing of the surgical site postoperatively.)
- Patients who undergo radiation therapy or chemotherapy due to malignant tumors, etc. (There is a risk that the surgical site may not heal properly.)
- Patients receiving bisphosphonate therapy.
- Patients who currently smoke.
- Patients who do not understand or cooperate with the treatment.
- Pregnant patients or patients who may be pregnant.
- Any other patient deemed unsuitable for participation in this study by the principal investigator (or co-investigator).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Japan2 sites, 2 recruiting
- Recruiting
Minami Tohoku Medical Clinic
Kōriyama, Fukushima
Shohei Kasugai, +81-24-934-5412, kenkyukanri@mt.strins.or.jp
Shohei Kasugai
- Recruiting
Hillside Akasaka Dental Clinic
Minato-Ku, Tokyo
Takamasa Miyahara, +81-3-6441-2422, miyahara0425@gmail.com
Takamasa Miyahara
About this study
Official title: Evaluation of the Efficacy and Safety of Periodontal Ligament Integrated Implants Via Residual Periodontal Ligament Tissue in Extraction Sockets
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:
Read more
- 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.
Read the detailed description
This multicenter, single-arm exploratory clinical trial investigates the efficacy and safety of periodontal ligament (PDL)-integrated implants placed immediately after tooth extraction, using residual periodontal ligament tissue within the extraction socket to achieve functional attachment. The investigational device is an unapproved medical implant designed to reproduce physiological tooth function by utilizing the periodontal tissue for anchorage and sensory integration, unlike conventional osseointegrated implants that rely solely on bone integration.
The rationale for this study is that preserving and integrating residual PDL tissue may allow the implant to develop a PDL-like attachment, potentially restoring physiological tooth mobility, mechanosensory feedback, and natural load distribution to the alveolar bone. This could enable improved long-term function and compatibility with adjacent natural teeth, particularly in cases where the implant is connected to them.
Participants will undergo immediate implant placement following extraction of a single-rooted tooth (incisor to premolar) that meets inclusion criteria. The implant-abutment assembly is secured temporarily using a fixation device to ensure stability during early healing. The fixation is maintained for approximately 9 weeks, followed by staged removal and functional loading through placement of a superstructure. Throughout the observation period (up to 48 weeks), multiple evaluations will be conducted to assess integration into the jawbone, periodontal attachment formation, bone remodeling, implant mobility, and patient-reported comfort.
Comprehensive radiographic, clinical, and physiological assessments will be performed to monitor healing dynamics, bone response, and periodontal adaptation. Safety will be assessed by recording adverse events related to surgery, device performance, or oral function. Oral hygiene and supportive care will be provided throughout the study.
The findings from this exploratory research are expected to provide foundational data regarding the biological feasibility, mechanical behavior, and clinical safety of PDL-integrated implants as a novel approach for immediate implant placement and restoration of physiological dental function.
- Conditions
- Tooth Extraction, Tooth Fractures, Dental Caries, Tooth Dislocation
- Being tested
- Periodontal Ligament-Integrated Implant
- Keywords
- Root Fracture, Crown Fracture, Tooth Mobility, Carious Tooth, Extraction site healing
- Medical subject headings
- Tooth Fractures, Dental Caries, Tooth Avulsion, Tooth Mobility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal Ligament-Integrated ImplantDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Periodontal Ligament-Integrated Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 weeks after implantation
Secondary outcomes (7)
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).
Measured: 9, 18, and 48 weeks postoperatively
Periodontal Pocket Depth
Periodontal pocket depth (mm) at Baseline (Visit 1 - approximatelly 11 weeks preoperative), and at 9, 18, 24, and 48 weeks postoperatively.
Measured: Baseline (approximately 11 weeks preoperative) to 48 weeks postoperatively
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.
Measured: Immediately after surgery to 36 weeks postoperatively
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.
Measured: Baseline (approximately 11 weeks preoperative) to 48 weeks postoperatively
Perceptual and Sensory Evaluation (Pain)
Perceptual and sensory evaluation (pain) using the numerical rating scale, conducted at Baseline (approximately 11 weeks preoperatively) (Visit 3), the day after surgery, and at 1, 3, 7, 9, 10, 14, 18, 24, 36, and 48 weeks postoperatively.
Measured: Baseline (approximately 11 weeks preoperatively) to 48 weeks postoperatively
Peri-Implant Bone Augmentation and Vertical Bone Resorption
Peri-implant bone augmentation (formation) and vertical bone resorption (dental X-ray) assessed at Baseline (approximately 11 weeks preoperatively) (Visit 1), immediately after surgery, and at 3, 7, 9, 14, 18, 24, and 48 weeks postoperatively.
Measured: Baseline (approximately 11 weeks preoperatively) to 48 weeks postoperatively
Formation of Periodontal Ligament Space
Formation of the periodontal ligament space around the implant (dental X-ray), assessed at 7, 9, 14, 18, 24, and 48 weeks postoperatively.
Measured: 7 to 48 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start20 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth ExtractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OrganTech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shohei Kasugai, PhD, Study director, Minami Tohoku Medical Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07302581
- Sponsor's protocol ID
- OrgT-CPS-001
- Other IDs
- jRCTs022240055
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Periodontal Ligament Integrated Implants Via Residual Periodontal Ligament Tissue in Extraction Sockets
- ClinicalTrials.gov ID
- NCT07302581
- Acronym / sponsor ID
- OrgT-CPS-001
- Conditions
- Tooth Extraction, Tooth Fractures, Dental Caries, Tooth Dislocation
- Keywords
- Root Fracture, Crown Fracture, Tooth Mobility, Carious Tooth, Extraction site healing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- OrganTech, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This multicenter, single-arm exploratory clinical trial investigates the efficacy and safety of periodontal ligament (PDL)-integrated implants placed immediately after tooth extraction, using residual periodontal ligament tissue within the extraction socket to achieve functional attachment. The investigational device is an unapproved medical implant designed to reproduce physiological tooth function by utilizing the periodontal tissue for anchorage and sensory integration, unlike conventional osseointegrated implants that rely solely on bone integration.
The rationale for this study is that preserving and integrating residual PDL tissue may allow the implant to develop a PDL-like attachment, potentially restoring physiological tooth mobility, mechanosensory feedback, and natural load distribution to the alveolar bone. This could enable improved long-term function and compatibility with adjacent natural teeth, particularly in cases where the implant is connected to them.
Participants will undergo immediate implant placement following extraction of a single-rooted tooth (incisor to premolar) that meets inclusion criteria. The implant-abutment assembly is secured temporarily using a fixation device to ensure stability during early healing. The fixation is maintained for approximately 9 weeks, followed by staged removal and functional loading through placement of a superstructure. Throughout the observation period (up to 48 weeks), multiple evaluations will be conducted to assess integration into the jawbone, periodontal attachment formation, bone remodeling, implant mobility, and patient-reported comfort.
Comprehensive radiographic, clinical, and physiological assessments will be performed to monitor healing dynamics, bone response, and periodontal adaptation. Safety will be assessed by recording adverse events related to surgery, device performance, or oral function. Oral hygiene and supportive care will be provided throughout the study.
The findings from this exploratory research are expected to provide foundational data regarding the biological feasibility, mechanical behavior, and clinical safety of PDL-integrated implants as a novel approach for immediate implant placement and restoration of physiological dental function.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Periodontal Ligament-Integrated Implant Placement | Experimental | Device: Periodontal Ligament-Integrated ImplantParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periodontal Ligament-Integrated ImplantThe 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. | Device | Periodontal Ligament-Integrated Implant Placement |
Primary outcome
Rate of integration into the jawbone at 24 Weeks Post-Implantation
Time frame: 24 weeks after implantation
Presence or absence of integration with the jawbone at 24 weeks postoperatively (Rate of integration into the jawbone).
7 secondary outcomes
Rate of integration into the jawbone Over Time
Time frame: 9, 18, and 48 weeks postoperatively
Periodontal Pocket Depth
Time frame: Baseline (approximately 11 weeks preoperative) to 48 weeks postoperatively
Physiological Instability (PT value) With Fixation
Time frame: Immediately after surgery to 36 weeks postoperatively
Physiological Tooth Mobility (PT Value) Without Fixation
Time frame: Baseline (approximately 11 weeks preoperative) to 48 weeks postoperatively
Perceptual and Sensory Evaluation (Pain)
Time frame: Baseline (approximately 11 weeks preoperatively) to 48 weeks postoperatively
Peri-Implant Bone Augmentation and Vertical Bone Resorption
Time frame: Baseline (approximately 11 weeks preoperatively) to 48 weeks postoperatively
Formation of Periodontal Ligament Space
Time frame: 7 to 48 weeks postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shohei Kasugai, PhD study director
Minami Tohoku Medical Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodontal Ligament-Integrated Implant in people with Tooth Extraction and Tooth Fractures, run by OrganTech, Inc. at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yoshitake Yamaguchi, PhD (＋８１-３-５８５９-５７６１, yoshitake.yamaguchi@organ-tech.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of integration into the jawbone at 24 Weeks Post-Implantation (time frame: 24 weeks after implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.