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Evaluating the effect and stability of synthetic bone with Low Crystalline Apatite: A Prospective, Randomized Clinical Trial

Evaluating the effect and stability of synthetic bone with Low Crystalline Apatite: A Prospective, Randomized Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0009159
Enrollment
30
Registered
2024-02-02
Start date
2024-03-27
Completion date
Unknown
Last updated
2025-04-07

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 : Patients who required alveolar bone grafting based on the inclusion criteria were randomized 1:1 to receive synthetic bone grafting containing Low Crystalline Apatite (LCA) in the exp

Sponsors

Osstem Implant
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients over 19 years of age who has completed the skeletal growth 2.Those who need alveolar bone grafts in the area where the tooth extraction is scheduled or has been performed 3. Non-smoker or smoke less than one pack (20 cigarettes) per day 4.Patients who voluntarily decided to participate in this clinical trial and agreed to the consent form of the subject in writing.

Exclusion criteria

Exclusion criteria: 1. a pregnant woman 2. People with uncontrolled systemic diseases that directly affect bone metabolism and healing (diabetes, osteomalacia, thyroid disease, etc.) 3. Those who have local lesions that may interfere with bone healing or lesions that may pose a threat to the future stability of the implant (a lesion with a high recurrence rate) 4. Those with localized mucosal lesions in the tooth defect or adjacent teeth and contralateral (e.g., erosive squamous lines) 5. The individual who has been continuously administered medications affecting bone metabolism for more than three years. (Bisphosphonates, Corticosteroids, etc.) 6. Those who have had radiation treatment on their heads or necks 7. A person who is immunocompromised by receiving immunosuppressants, anticancer drugs, etc 8 .A patient undergoing chemotherapy. 9.An individual who smokes more than 20 cigarettes per day 10. Individuals with difficulty maintaining proper oral hygiene, as well as patients with uncontrolled gingivitis, periodontitis, or dental caries 11. Cases in which the investigator determines that participation is inappropriate due to ethical concerns or potential impact on clinical trial results

Design outcomes

Primary

MeasureTime frame
Radiologic evaluation of implanted bone grafts : - CBCT analysis: CTs taken at the 2-week postoperative evaluation and CTs taken at the 16-week evaluation will be superimposed and the volume difference will be calculated.

Secondary

MeasureTime frame
Histometric analysis;Patient Subjective Assessment: Pain Score (VAS);Infection after bone graft surgery

Countries

Korea, Republic of

Contacts

Public ContactLee HeeYoung

Hallym University Medical Center

newhealth2020@naver.com+82-31-380-1513

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026