Primary and Secondary Elevations of Maxillary Sinuses: a Prospective Clinical Study in the Posterior Maxillary Region
Launched by NANFANG HOSPITAL, SOUTHERN MEDICAL UNIVERSITY · Oct 24, 2023
Trial Information
Current as of July 25, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at different methods of placing dental implants in the upper jaw, specifically in the back area where teeth may be missing. The goal is to understand how these methods affect patients in terms of their comfort and the changes in their jaw and gum tissue over time. About 40 participants will be involved in the study at Southern Medical University Southern Hospital. To be eligible, participants need to be at least 18 years old and should have been missing a back upper tooth for at least three months. They also need to meet certain health criteria, such as having sufficient bone structure for the implant and no serious sinus issues.
Participants in the study will go through a screening process to ensure they qualify and will then receive either immediate or delayed implant treatment, depending on the group they are assigned to. After the procedure, patients will be asked about their experiences and undergo check-ups at 3 months, 6 months, and 1 year to assess how well the implant is healing and how they feel about the results. It’s important for potential volunteers to know that they will need to sign a consent form and commit to returning for follow-up visits to monitor their progress.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Age≥ 18 years old
- • 2. If the posterior maxillary tooth is missing for ≥ 3 months, the patient requires implant restoration and the preoperative examination meets the indications for intramaxillary sinus lift
- • 3. Can be scanned with radiology equipment before and after surgery
- • 4. RBH ≤ 5mm, alveolar ridge width ≥5mm, each implant site is measured on CBCT
- • 5. During implant healing, there is no removable restoration at the implant site
- • 6. No history of acute or chronic sinusitis disease, no history of maxillary sinus disease, and no history of previous maxillary sinus surgery
- • 7. Be willing to sign informed consent and authorization form, and be able to return to the clinic on time
- Exclusion Criteria:
- • 1. Heavy smokers (10 cigarettes smoked ≥ day)
- • 2. Uncontrolled diabetes (glycated hemoglobin \>7%), metabolic bone disease, autoimmune disease or other systemic diseases, the body can hardly withstand implant surgery
- • 3. Mentally unable, pregnant or pregnant women
- • 4. Any history of contraindications or significant impact on dental implant placement, such as bisphosphonate drug use, chemotherapy or immunosuppressants, head and neck radiotherapy, autoimmune disease, and hypertension
- • 5. Untreated periodontal disease, endodontics, or other oral diseases
- • 6. Bruxism patients
- • 7. Previous implant implant failure at the surgical site
- • 8. Anatomical changes in the maxillary sinus, such as maxillary sinus septum or mucosal swelling (defined as the mean thickness of the Schneider membrane at the base of the maxillary sinus \> 2 mm)
About Nanfang Hospital, Southern Medical University
Nanfang Hospital, affiliated with Southern Medical University, is a leading medical institution in China renowned for its comprehensive clinical services and commitment to advancing healthcare through research and education. As a clinical trial sponsor, Nanfang Hospital leverages its state-of-the-art facilities and a multidisciplinary team of expert researchers to conduct innovative studies aimed at improving patient outcomes and contributing to the global medical community. The hospital's focus on ethical standards and patient safety ensures that all trials are conducted with the highest level of integrity and scientific rigor.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Guangzhou, Guangdong, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported