Efficacy and Safety Evaluation Study of Implants with Periodontal Ligament

JRCT ID: jRCTs022240055

Registered date:27/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: caries, tooth fracture, luxation of tooth
• Date of first enrollment: 27/01/2025
• Target sample size: 6
• Study type: Interventional
• Intervention(s): Immediately after tooth extraction, a periodontal ligament-integrated dental implants will be placed into the extraction socket and the periodontal ligament will be evaluated for jaw bone engraftment (efficacy) and safety up to 48 weeks postoperatively.

Outcome(s)

• Primary Outcome: Presence or absence of jaw bone engraftment at 24 weeks postoperatively (jaw bone engraftment rate)

Secondary Outcome

Efficacy endpoints
1) Jaw bone engraftment rate
2) Periodontal pockets (mm)
3) Physiologic mobility with side screw fixation(periotest value)
4) Physiological mobility without side screw fixation(periotest values), and clinical mobility as assessed by the surgeon (Miller's classification)
5) Perception and sensation evaluation (pain) by Numerical rating scale
6) Bone addition (formation) and vertical bone resorptionaround the implant (dental x-ray)
7) Periodontal ligament cavity formation(dental x-ray)

Other endpoints (quality of life assessment)
1) Oral-related QOL at preoperative (Japan Prosthodontic Society)

Safety evaluation items
1) Incidence of disease, frequency of device deficiency

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients with only one single-rooted tooth from front tooth to premolars in the upper and lower jaws that requires extraction due to caries or tooth fracture, and with healthy periodontal tissue remaining around the root of the tooth to be extracted.
2) Patients who also have natural teeth with healthy periodontal tissues adjacent to the tooth to be extracted, and who have no abnormalities on dental X-ray, CT scan, periodontal pocket examination, or physiologic mobility examination. Patients must be able to achieve an appropriate occlusion with the opposing teeth.
3) Patients must be at least 18 years of age at the time of informed consent.
4) Patients who have given their written informed consent to participate in this clinical study.

Exclude criteria

1) Patients whose jawbone is still growing.
2) Patients undergoing orthodontic treatment or wearing post orthodontic retention braces.
3) Patients with multiple missing teeth or edentulous jaw with multiple missing occlusal support areas of remaining teeth.
4) Patients with a periodontal pocket of 4 mm or more around the entire circumference of the root of the tooth to be extracted or the adjacent teeth of the tooth to be extracted.
5) Patients with periodontitis or other bacterial infection or acute inflammation of the tooth to be extracted.
6) Patients with apical periodontitis in the target tooth for extraction.
7) Patients with two or more consecutive or free end defects due to the extraction of the target tooth.
8) Patients whose target tooth has already been extracted.
9) Patients who are expected to have difficulty in extracting the target tooth.
10) Patients who are not in good health to allow tooth extractions or surgical procedures necessary for implant treatment with this product.
11) Patients with abnormal root morphology or position (crooked, tilted, etc.) of the tooth to be extracted.
12) Patients with root size (root length less than 10 mm, root diameter of the cervix less than 5.4 mm long and 3.4 mm short) or dental malposition of the tooth to be extracted that prevents the implantation of this product.
13) Patients with open bite.
14) Patients with a history of hypersensitivity to the components of this product or similar products.
15) Patients with alveolar bone resorption in the tooth where the implant is to be placed.
16) Patients with a predisposition to hemorrhage. (abnormal bleeding may occur, leading to poor healing of the surgical site).
17) Patients with uncontrolled diabetes mellitus. (May cause poor healing of the surgical site and increased susceptibility to infection.)
18) Patients for whom general oral surgery is contraindicated. (Invasive procedures may worsen disease, cause recurrence of pre-existing conditions, or result in poor healing of the surgical site after surgery.)
19) Patients receiving irradiation or chemotherapy for malignant tumors. (There is a risk that healing of the surgical site may not be achieved.)
20) Patients receiving bisphosphonates.
21) Patients who are currently smoking.
22) Patients who are unable to understand or cooperate with treatment.
23) Pregnant women or patients who may be pregnant.
24) Other patients who are judged by the principal (sub)investigator to be inappropriate to participate in this study.

Related Information

• Primary Sponsor: Shohei Kasugai
• Secondary Sponsor: OrganTech. Inc.