Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06105489

"Tunnel" Flap vs Trapezoidal Flap for Lateral Sinus Lift

Led by Studio Dentistico Associato Sivolella · Updated on 2023-10-27

36

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

"Tunnel" Flap vs Trapezoidal Flap for Lateral Sinus Lift

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Edentulous or partly edentulous patients with unilateral loss of teeth in the maxillary premolar or molar areas
  • Severe alveolar atrophy with residual alveolar ridge height up to 3 mm
Not Eligible

You will not qualify if you...

  • Severe illness
  • Head and neck radiation therapy
  • Chemotherapy
  • Antiresorptive therapy
  • Uncontrolled diabetes
  • Uncontrolled periodontal disease
  • Smoking more than 10 cigarettes per day
  • Facial or neck inflammatory or oncologic diseases
  • Obliteration of sinus ostium and osteomeatal complex

AI-Screening

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Trial Site Locations

Total: 1 location

1

Studio Dentistico Associato Graiff e Sivolella

Padova, Italy, 35127

Actively Recruiting

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Research Team

S

Stefano Sivolella, DDS, PhD

CONTACT

D

Dario Azeglio Castagna

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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