Maxillary Sinus Augmentation Via the "Bone Lid Technique"

Maxillary Deficiency Clinical Trial

— SINUSLID_2023  

Official title:

Maxillary Sinus Augmentation Via the "Bone Lid Technique"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06222970
• Other study ID #: SINUSLID_2023
• Status: Recruiting
• Start date: May 4, 2020
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: University of Pisa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Maxillary sinus augmentation is one of the most performed procedures to increase the bone quantity of the atrophic maxilla in order to allow implant placement. The aim of the present case series was to describe a surgical protocol to perform maxillary sinus augmentation with the "bone lid technique", and its outcomes in a cohort of patients eligible for the procedure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: September 18, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Partially or fully edentulous patients requiring an implant-prosthetic rehabilitation of the premolar or molar maxillary areas with a residual ridge height lower than 4 mm.

• Patients needing for a unilateral or bilateral sinus lift with a lateral wall approach.

Exclusion Criteria:

• Patients under treatment with immunosuppressive agents

• Patients under treatment with medications that could impair bone metabolism.

• Patients pregnant or breastfeeding.

• Patients who had received irradiation treatment to the head and neck area.

• Patients with uncontrolled diabetes.

• Patients with uncontrolled periodontal disease.

Related Conditions & MeSH terms

• Maxillary Deficiency

Intervention

Procedure:
• Bone lid repositioning in course of sinus lift
A full-thickness flap was elevated to access the lateral maxillary bone wall. Subsequently, a lateral access window was prepared using a piezoelectric device with specific bone tips, delimitating a trapezoidal bone lid. Once the antrostomy was completed, the bone lid was gently removed with a Lucas surgical curette and anatomical tweezers, with great care to avoid damages to the Schneiderian membrane. The Schneiderian membrane was detached from the bone layer using specific sinus curettes. In case of sinus membrane perforation, the membrane was raised in all directions. All clinical cases received a cortical bone lamina to avoid graft particles displacement in the maxillary sinus. The elevated space was filled with chips of cortico-spongious bone. The antrostomy was then covered with the bone lid (osteotomy window), previously removed and preserved in physiological solution and fixed in the original anatomical position with a surgical glue. The flap was then repositioned and sutured.

Locations

Country	Name	City	State
Italy	U.O. Odontostomatologia e Chirurgia del Cavo Orale	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
University of Pisa

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone gain	Measurement of bone height and width	6 months