A prospective, single-arm, single-center, investigator initiated clinical trial to evaluate the safety and effectiveness of a patient- specific bone distraction device that combines a patient-specific bone fixation site and a ready-made distractor for patients who need maxillofacial bone distraction

A prospective, single-group, single-organ researcher's clinical trial to evaluate the stability and effectiveness of patient-specific bone extensors combining patient-specific bone fixation and ready-made bone extensors in patients who need bone elongation in the jawbone

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0008094

Enrollment

Registered

2023-01-09

Start date

2022-12-09

Completion date

Unknown

Last updated

2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : It uses a patient-tailored bone extensor that combines a patient-tailored bone retainer and an off-the-shelf bone extensor manufactured by applying titanium 3D printing process techno

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who are scheduled to visit the dentist at Chung-Ang University Hospital and undergo surgery at Chung-Ang University Hospital. 2. Patients who need to re-position, enlargement, or bone reconstruction of the jaw face bone due to birth defects, trauma, tumors, or excessive plastic surgery. 3. Patients who need to re-position, dilatation, or bone reconstruction of the jaw face bone due to skeletal or dental malocclusion. 4. Patients between the ages of 5 and under 50 5. Patients who maintain good oral hygiene. 6. A person who voluntarily agrees to participate in a clinical trial and is willing to comply with the test plan

Exclusion criteria

Exclusion criteria: 1. A person with uncontrolled metabolic diseases (e.g., diabetes, osteomalacia, thyroid disease) 2. Those who are taking or are planning to take drugs that may affect bone metabolism ? Bisphosphonate, Recombinant human parathyroid hormone (rhPTH), Denosumab, etc 3. Those who have uncontrolled gingivitis, periodontitis, and dental caries 4. A person with a severe heart disease or severe liver dysfunction 5. A person who has an infectious disease with a risk of recurrence 6. A person who has blood diseases (leukaemia, hemophilia, sepsis, etc.) 7. Those who cannot stop taking steroids and anticoagulants before surgery 8. A person who cannot discontinue systemic adrenocortical hormones or anabolic steroids for three months after surgery 9. A person with osteomalacia or Paget disease 10. A person who has experience of receiving radiation treatment at the surgical site 11. Those who are allergic to implant materials 12. Patients with syphilis and severe epilepsy 13. Those who are substance abusers or alcoholics 14. Smokers 15. Where the tester determines that participation in the clinical trial is inappropriate because it may affect other, ethical or clinical trial results ? Specific reasons are stated in the case record

Design outcomes

Primary

Measure	Time frame
Bone elongation as planned prior to surgery;Amount of bone change (expansion amount);Amount of change in tooth position;Change in tooth angle	—

Secondary

Measure	Time frame
Patient satisfaction;The incidence of abnormalities in soft and hard tissues (%);All adverse events occurring to clinical trial subjects during the clinical trial period	—

Countries

Korea, Republic of

Contacts

Public ContactUi-lyong Lee

Chung-Ang Univerisity Hospital

davidjoy76@gmail.com+82-2-6299-2875

Outcome results