Volumetric Analysis of Maxillary Sinus After Guided Lateral Sinus Lift Procedure

Dental Implant Clinical Trial

Official title:

Volumetric Analysis of Maxillary Sinus After Guided Lateral Sinus Lift Procedure With Simultaneous Implant Placement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06130657
• Other study ID #: AUAREC202100012-06
• Status: Completed
• Phase: N/A
• Start date: December 29, 2020
• Est. completion date: February 1, 2023

Study information

• Verified date: November 2023
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to present a guided lateral window sinus lift (GLSL) procedure with the aid of a fully digital workflow using surgical templates for window osteotomy preparation and implant placement.

Description:

In Group 1; The surgical procedure began with the adaptation of a prefabricated guide to the surgical site, ensuring firm stabilization. Implant positions were marked, and after the removal of the guide, a crestal incision was made. A mucoperiosteal flap was reflected, exposing the maxillary sinus and alveolar crest. The guide was readapted, marking implant positions, and a lateral window was formed using a bur or piezotome. Sinus membrane elevation was performed carefully. Implants were placed with graft material beneath the elevated membrane. In cases of bony plate preservation, the window was covered. In Group 2 (Lateral Maxillary Sinus Floor Elevation without a surgical guide), a crestal incision and mucoperiosteal flap exposed the sinus. A bony window was created, and careful elevation of the sinus floor followed. Implant osteotomies were completed, and graft material was packed into the sinus. A resorbable membrane was applied, and the flap was sutured. NanoboneÒ was used as the standard graft material in both groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy adult patients (over 18 years of age), without any systemic complication.
• Patients who need for dental implant in posterior maxilla with bone height below the maxillary sinus is < 6 mm.
• Non smokers or patients who smoked less than 11 cig/day Will be included.

Exclusion Criteria:

• Uncontrolled systemic diseases which affect bone healing.
• Presence of any pathology in the site of operation.

Related Conditions & MeSH terms

• Dental Implant

Intervention

Procedure:
• Lateral Maxillary Sinus Floor Elevation using surgical guide
The surgical procedure begins with securing a prefabricated guide firmly to the surgical site. Implant positions are marked, and after guide removal, a crestal incision is made 1 mm palatal to the marked point, extending with sulcular and vertical incisions. A full-thickness mucoperiosteal flap is reflected to expose the maxillary sinus and alveolar crest. After readapting the surgical guide to the bone, implant positions are marked, and cutting edges are tracked. The lateral window is formed by extending and connecting mesial and distal borders, created using piezotome. The sinus membrane is carefully reflected and elevated with a surgical curette to avoid iatrogenic perforation. Implant fixtures are then placed using the identical surgical guide, followed by graft material placement beneath the elevated sinus membrane. If the bony plate is preserved, the lateral window is covered with the plate.
• Lateral Maxillary Sinus Floor Elevation without surgical guide
The sinus's lateral wall is exposed through a crestal incision and a mucoperiosteal flap. A bony window is created, and upon its removability, the sinus floor is carefully elevated using sinus elevation curettes, taking care to avoid membrane perforation. In cases of perforation, a resorbable collagen membrane is applied to cover the hole. Implant osteotomies are then completed following the standard sequential placement protocol. Graft material, mixed with normal saline, is gently packed into the sinus to fill the cavity with bone substitute material and achieve the desired bone height. Finally, a resorbable membrane is placed on the outer surface of the window, and the flap is sutured for primary closure.

Locations

Country	Name	City	State
Egypt	Faculty of Dental Medicine	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Ahmed Zewail

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maxillary sinus volume	In cubic centimetre (cm3)	Preoperative, Immediate postoperative, 6 Months
Secondary	Bone Gain	Im Millimeter (mm)	Immediate postoperative, 6 Months
Secondary	Implant stability	In implant stability quotient (ISQ)	Intra-operative, 6 Months