"Tunnel" Flap vs Trapezoidal Flap for Lateral Sinus Lift

Studio Dentistico Associato Sivolella

Status: Enrolling

Conditions: Severe Atrophy of the Edentulous Maxilla

Treatments: Procedure: Lateral Sinus Lift using tunnel flap technique; Procedure: Lateral Sinus Lift using crestal incision flap

Study type: Interventional

Funder types: Other

Identifiers

NCT06105489

20464

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• edentulous or partly edentulous patients with a unilateral loss of teeth in the maxillary premolar or molar areas
• severe alveolar atrophy and a residual severe alveolar ridge height up to 3 mm

Exclusion criteria

• severe illness
• head and neck radiation therapy
• chemotherapy
• antiresorptive therapy
• uncontrolled diabetes
• uncontrolled periodontal disease
• smoking >10 cigarettes per day
• facial or neck inflammatory or oncologic diseases
• obliteration of sinus ostium and osteomeatal complex

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

36 participants in 2 patient groups

Tunnel flap design

Experimental group

Description:

Participants will undergo a lateral sinus lift procedure in which a single vertical anterior incision will be made at least 10 mm mesially to the expected outline of the bony window.

Treatment:

Procedure: Lateral Sinus Lift using tunnel flap technique

Trapezioidal flap design

Active Comparator group

Description:

Participants will undergo a lateral sinus lift procedure. The incision will be made horizontally on the top of the alveolar ridge, with two additional releasing incisions in the mesial and distal regions.

Treatment:

Procedure: Lateral Sinus Lift using crestal incision flap