Maxillary sinus augmentation with Bontree plus? or Bio-oss? Multicenter comparative clinical study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0009195

Enrollment

Registered

2024-02-22

Start date

2024-03-01

Completion date

Unknown

Last updated

2024-03-04

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 : This clinical study involves performing lateral approach maxillary sinus floor elevation surgery using Bontree plus® or Bio-Oss® in patients with missing upper posterior teeth who are

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 19 years of age or older - Individuals requiring staged implant placement through lateral approach maxillary sinus floor elevation due to residual alveolar bone height of less than 5mm in the upper posterior maxilla. - Individuals who have listened to a detailed explanation of the study, comprehended it, voluntarily decided to participate, and provided informed consent. - Individuals willing and able to comply with the research procedures.

Exclusion criteria

Exclusion criteria: - Individuals with systemic conditions that may impact treatment: Within the last 6 months, those who have experienced unstable angina, myocardial infarction, or transient ischemic attack (TIA), or undergone percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass grafting (CABG). Within the last 6 months, those with severe cerebrovascular disorders (stroke, cerebral infarction, cerebral hemorrhage, etc.). Clinically significant renal or hepatic dysfunction. Uncontrolled diabetes. Pathological conditions of the maxillary sinus that may seriously impact surgery (infection, cysts, tumors, polyps, etc.). - Heavy smokers (more than 10 cigarettes per day). - Alcohol or substance abuse. - Pregnant or lactating individuals. - Participants involved in other clinical trials that could interfere with the results of this study. - Lack of willingness or inability to provide consent. - Individuals deemed inappropriate for participation in this study by the principal investigator or study coordinator for various reasons.

Design outcomes

Primary

Measure	Time frame
Newly formed bone area ratio	—

Secondary

Measure	Time frame
the quantitative and qualitative status of the grafted maxillary sinus area	—

Countries

Korea, Republic of

Contacts

Public ContactGYEONG SEOK JEONG

Seoul National University Dental Hospital

taekigogo@naver.com+82-2-6256-3144

Outcome results