Efficacy and Safety Evaluation Study of Implants With Periodontal Ligament (NCT07302581) | Clinical Trial Compass
RecruitingNot Applicable
Efficacy and Safety Evaluation Study of Implants With Periodontal Ligament
Japan6 participantsStarted 2025-06-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of integration into the jawbone at 24 Weeks Post-Implantation