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Completed

NCT Number: NCT06130657

Volumetric Analysis of Maxillary Sinus After Guided Lateral Sinus Lift Procedure

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.

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Key information

Conditions

Lateral Sinus Lifting Dental Implant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dental Medicine

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Maxillary sinus volume

    Time frame: Preoperative, Immediate postoperative, 6 Months

    In cubic centimetre (cm3)

Secondary outcomes

  1. Bone Gain

    Time frame: Immediate postoperative, 6 Months

    Im Millimeter (mm)

  2. Implant stability

    Time frame: Intra-operative, 6 Months

    In implant stability quotient (ISQ)

Sponsors and collaborators

Lead sponsor

Ahmed Zewail

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 14, 2023
Registry last updated
Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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