"Tunnel" Flap vs Trapezoidal Flap for Lateral Sinus Lift

Last updated: October 23, 2023
Sponsor: Studio Dentistico Associato Sivolella
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Lateral Sinus Lift using crestal incision flap

Lateral Sinus Lift using tunnel flap technique

Clinical Study ID

NCT06105489
20464
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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

Study Design

Total Participants: 36
Treatment Group(s): 2
Primary Treatment: Lateral Sinus Lift using crestal incision flap
Phase:
Study Start date:
October 21, 2022
Estimated Completion Date:
October 21, 2026

Connect with a study center

  • Studio Dentistico Associato Graiff e Sivolella

    Padova, 35127
    Italy

    Active - Recruiting

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