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Evaluation of the Clinical Effect of External Sinus Floor Elevation with Simultaneous Implantation Using Different Lateral Wall Bone Block Treatments: A Multicenter Randomized Controlled Trial

Evaluation of the Clinical Effect of External Sinus Floor Elevation with Simultaneous Implantation Using Different Lateral Wall Bone Block Treatments: A Multicenter Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128623
Enrollment
Unknown
Registered
2026-07-23
Start date
2026-09-01
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

Dentition defect

Interventions

Lateral wall bone fragment impaction group:Lateral wall bone fragment flipped in
Lateral Wall Bone Fragment Reposition Group:Lateral wall bone fragment repositioning

Sponsors

Stomatology Hospital,Zhejiang University School Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.18 to 70 years old, regardless of gender; 2.Maxillary sinus lift surgery is required with simultaneous implantation; 3.Single or consecutively missing no more than 3 teeth in the maxillary premolar or molar area, with a healing time of more than 3 months; 4.The alveolar socket in the missing tooth area is healing well, with no acute inflammation or purulent exudate; 5.Preoperative CBCT shows a residual bone height (RBH) of 3–5 mm at the missing tooth site; 6.No untreated periapical disease or periodontal disease; 7.Voluntarily participate in the trial and sign the informed consent form; 8.Good oral hygiene habits.

Exclusion criteria

Exclusion criteria: 1.Significant abnormalities in liver and kidney function (AST, ALT, creatinine >= 1.5 times the upper limit of normal); 2.Coagulation dysfunction (APTT, PT, FIB >= 1.5 times the upper limit of normal); 3.Patients with a history of radiotherapy and chemotherapy in the maxillofacial region, nasopharynx, and neck; 4.Areas where local control has not been achieved or there is obvious infection; 5.Acute and chronic inflammation of the maxillary sinus; 6.Women who are pregnant or breastfeeding; 7.Heavy smokers (more than 20 cigarettes per day at the time of surgery); 8.A history of intravenous bisphosphonate use, or currently using or having taken oral bisphosphonates within the past 3 months; 9.Patients who are currently receiving or have received treatment with other drugs that may affect bone metabolism in the past 3 months (such as glucocorticoids, immunosuppressants); 10.Those who are taking anticoagulant drugs and are assessed as unable to safely pause them during the perioperative period; 11.Those with mental illness, psychological disorders, or neurological diseases, such as epilepsy; 12.Individuals with uncontrolled hematological disorders and cardiovascular diseases; 13.Individuals with uncontrolled endocrine metabolic diseases, such as diabetes, osteopathy, and thyroid disorders; 14.Severe degenerative diseases; 15.Known allergy to the local anesthetic intended for use (Articaine with epinephrine injection) or to the metal components of the implant, or allergy to cephalosporin antibiotics with no safe alternative medication available; 16.Additional vertical or horizontal bone augmentation is required; 17.Researchers consider other circumstances in which participation in the trial is not appropriate.

Design outcomes

Primary

MeasureTime frame
Maxillary sinus mucosal perforation rate;

Secondary

MeasureTime frame
Bone augmentation volume;Initial stability of the implant;Sinus bone augmentation;Apical bone height;Bone height;Postoperative Pain Index;Implant success rate;Postoperative swelling index;Soft Tissue Healing Index;Marginal bone level;

Countries

China

Contacts

Public ContactGuoli Yang

Stomatology Hospital,Zhejiang University School Medicine

guo_li1977@zju.edu.cn+86 13600529781

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026