Volumetric Analysis of Maxillary Sinus After Guided Lateral Sinus Lift Procedure

NCT06130657 | Completed

• 1 other identifier: AUAREC202100012-06
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Lateral Sinus Lifting; Dental Implant

Keywords

Sinus lifting; Dental implant

Outcome Measures

Primary Outcomes (1)

• Maxillary sinus volume

  In cubic centimetre (cm3)

  Preoperative, Immediate postoperative, 6 Months

Secondary Outcomes (2)

• Bone Gain

  Immediate postoperative, 6 Months

• Implant stability

  Intra-operative, 6 Months

Study Arms (2)

Group 1: Lateral Maxillary Sinus Floor Elevation using surgical guide

ACTIVE COMPARATOR

Procedure: Lateral Maxillary Sinus Floor Elevation using surgical guide

Group 2: Lateral Maxillary Sinus Floor Elevation without surgical guide

ACTIVE COMPARATOR

Procedure: Lateral Maxillary Sinus Floor Elevation without surgical guide

Interventions

Lateral Maxillary Sinus Floor Elevation using surgical guide 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 1: Lateral Maxillary Sinus Floor Elevation using surgical guide

Lateral Maxillary Sinus Floor Elevation without surgical guide 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.

Group 2: Lateral Maxillary Sinus Floor Elevation without surgical guide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ahmed Zewail: lead

Study Sites (1)

Faculty of Dental Medicine

Asyut, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident at the Department of Oral and Maxillofacial Surgery

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 14, 2023
• Study Start: December 29, 2020
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

EG (1)