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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06222970
Other study ID # SINUSLID_2023
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


Related Conditions & MeSH terms


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
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