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Clinical evaluation of the application of Bio Oss and THE Graft bone powder in maxillary sinus floor elevation

Clinical evaluation of the application of Bio Oss and THE Graft bone powder in maxillary sinus floor elevation

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20241227003
Enrollment
118
Registered
2024-12-27
Start date
2024-12-30
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Patients with missing teeth in the maxillary posterior region need to undergo maxillary sinus external elevation surgery due to insufficient bone mass Maxillary sinus external elevation Dental implant

Interventions

When the patient undergoes maxillary sinus floor elevation surgery, THE Graft powder is used for space filling.,When the patient undergoes maxillary sinus floor elevation surgery, Bio-Oss powder is u
Experimental Procedure/Surgery,Active Comparator Procedure/Surgery
External elevation of maxillary sinus floor with THE Graft group,External elevation of maxillary sinus floor with Bio-Oss group

Sponsors

National Natural Science Foundation of China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. No major systemic diseases 2. Missing teeth in the maxillary posterior region for more than 3 months, with a bone height of less than 5mm from the top of the alveolar ridge to the bottom of the maxillary sinus in the missing tooth area. Maxillary sinus floor external elevation surgery is required to increase the height of the alveolar ridge bone and implant an implant at the same time 3:.Previously in good physical condition, able to undergo local anesthesia surgery in the oral cavity 4. Patients with chronic periodontitis should be treated first and recruited after their periodontal health stabilizes

Exclusion criteria

Exclusion criteria: 1: Contraindications to implant surgery, such as uncontrolled diabetes or other systemic diseases 2: Heavy smoking>20 cigarettes/day 3: Untreated periodontal disease, pulp disease, or other oral diseases 4: History of radiation therapy for head, neck, and maxillofacial region 5: Pregnant and lactating women during recruitment period 6: Previously performed implant implantation or bone augmentation surgery at the current surgical site 7: The habit of clenching teeth or severe wear and tear 8: The patient does not have good compliance 9: Acute maxillary sinusitis, presence of gas-liquid plane in the maxillary sinus, polyps in the posterior nasal cavity of the maxillary sinus, maxillary sinus mucinous cysts, large maxillary sinus cysts with unknown diagnosis, benign or malignant tumors in the maxillary sinus area 10: Disabled individuals who are unable to clean their oral hygiene on their own 11: Patients with psychological and mental disorders

Design outcomes

Primary

MeasureTime frame
Elevation height of maxillary sinus floor Before surgery, immediately after surgery, 6 months after surgery, 1 year after surgery, 3 years after surgery Evaluation of maxillary sinus floor elevation height using oral panoramic film and cone beam computed tomography

Secondary

MeasureTime frame
Changes in bone resorption, bone powder volume, and height at the edge of implants Before surgery, immediately after surgery, 6 months after surgery, 1 year after surgery, 3 years after surgery Assessment of changes in bone resorption, bone powder volume, and height at the edge of implants using panoramic dental images and cone beam computed tomography,Implant survival rate 6 months after surgery, 1 year after surgery, 3 years after surgery Calculate whether the implant remains and calculate the implant survival rate

Countries

China

Contacts

Public ContactHui Wang

Zhejiang University

7322020@zju.edu.cn17857125733

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026