"Tunnel" Flap vs Trapezoidal Flap for Lateral Sinus Lift

Summary

The goal of this clinical trial is to evaluate the efficacy of the lateral sinus lift procedure using the tunnel technique flap in comparison to the traditional lateral sinus lift in partially or totally edentulous patients with loss of teeth in the maxillary premolar or molar areas and severe alveolar atrophy. The primary questions it aims to answer are:

1. Is the tunnel flap technique more suitable for lateral sinus lift than the trapezoidal flap technique in terms of post-operative symptoms?
2. Is the tunnel technique safer and more effective than the trapezoidal flap technique in terms of complication rate and the effectiveness of bone grafting?

Participants will undergo the lateral sinus lift procedure using the tunnel technique, which involves making a vertical anterior incision. Patients will receive follow-up care, including phone contact the day after the procedure to detect any issues, and they will keep a diary during the week after surgery to record visual analog scale (VAS) pain values and analgesics taken. Follow-up surgical visits will be scheduled for suture removal and at 30 days after suture removal. After 6 months, dental implants will be inserted, and prosthetic rehabilitation will take place 6 months later. Implants will be monitored for up to 12 months after prosthetic rehabilitation.

Researchers will compare the outcomes of tunnel flap technique lateral sinus lift with the trapezoidal flap sinus lift.

Conditions

• Severe Atrophy of the Edentulous Maxilla

Interventions

PROCEDURE

Lateral Sinus Lift using tunnel flap technique

The surgical procedure will involve the following steps: * A single vertical anterior incision will be made, at least 10 mm mesially to the expected outline of the bony window. * A full-thickness flap will be carefully elevated to expose the lateral wall of the maxillary sinus. * A trap door will be created in the lateral wall of the maxillary sinus using either a dedicated piezosurgical insert or a straight handpiece with a 3mm round diamond bur. * The door will be removed. * The sinus membrane will be gently elevated using various-shaped curettes until it becomes completely detached from the lateral, inferior, and medial walls of the sinus. * The maxillary sinus will be filled with a heterologous bone graft with a well-documented efficacy. * The flaps will be meticulously sutured.

PROCEDURE

Lateral Sinus Lift using crestal incision flap

The surgical procedure will involve the following steps: * A horizontal incision is made on the top of the alveolar ridge, along with two additional releasing incisions in the mesial and distal regions. * A full-thickness flap will be carefully elevated to expose the lateral wall of the maxillary sinus. * A trap door will be created in the lateral wall of the maxillary sinus using either a dedicated piezosurgical insert or a straight handpiece with a 3mm round diamond bur. * The door will be removed. * The sinus membrane will be gently elevated using various-shaped curettes until it becomes completely detached from the lateral, inferior, and medial walls of the sinus. * The maxillary sinus will be filled with a heterologous bone graft with a well-documented efficacy. * The flaps will be meticulously sutured.

Sponsors & Collaborators

• Studio Dentistico Associato Sivolella

  lead OTHER

Principal Investigators

• Stefano Sivolella, DDS, PhD · Studio Dentistico Associato Sivolella

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-21

Primary Completion

2024-10-21

Completion

2026-10-21

Countries

• Italy

Study Locations