Volumetric Analysis of Maxillary Sinus After Guided Lateral Sinus Lift Procedure

NCT ID: NCT06130657

Last Updated: 2023-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-29
• Study Completion Date: 2023-02-01

Brief 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.

Detailed 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.

Conditions

Lateral Sinus Lifting; Dental Implant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1: Lateral Maxillary Sinus Floor Elevation using surgical guide

Group Type: ACTIVE_COMPARATOR

Lateral Maxillary Sinus Floor Elevation using surgical guide

Intervention Type: PROCEDURE

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.

Group 2: Lateral Maxillary Sinus Floor Elevation without surgical guide

Group Type: ACTIVE_COMPARATOR

Lateral Maxillary Sinus Floor Elevation without surgical guide

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ahmed Zewail

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Zewail

Resident at the Department of Oral and Maxillofacial Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Faculty of Dental Medicine

Asyut, , Egypt

Countries

Egypt

Other Identifiers

AUAREC202100012-06

Identifier Type: -

Identifier Source: org_study_id