Volumetric Analysis of Maxillary Sinus After Guided Lateral Sinus Lift Procedure

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Implant; Lateral Sinus Lifting
• Intervention / Treatment: Procedure: Lateral Maxillary Sinus Floor Elevation using surgical guide; Procedure: Lateral Maxillary Sinus Floor Elevation without surgical guide

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assuit, Egypt
    • Faculty of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1: Lateral Maxillary Sinus Floor Elevation using surgical guide	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.
Active Comparator: Group 2: Lateral Maxillary Sinus Floor Elevation without surgical guide	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maxillary sinus volume	In cubic centimetre (cm3)	Preoperative, Immediate postoperative, 6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone Gain	Im Millimeter (mm)	Immediate postoperative, 6 Months
Implant stability	In implant stability quotient (ISQ)	Intra-operative, 6 Months

Collaborators and Investigators

• Sponsor: Ahmed Zewail

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2020
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: November 9, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 14, 2023

Study Record Updates

• Last Update Posted (Actual): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 9, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Dental implant; Sinus lifting
• Other Study ID Numbers: AUAREC202100012-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No