Clinical trial NCT06105489: "Tunnel" Flap vs Trapezoidal Flap for Lateral Sinus Lift
Official title: "Tunnel" Flap vs Trapezoidal Flap for Lateral Sinus Lift: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Severe Atrophy of the Edentulous Maxilla
Keywords: Lateral sinus lift
Tunnel technique
Dental Implant
Patient Reported Outcome Measures
Bone Regeneration
Flap Design
Histology
Heterologous bone
Cone Beam Computed Tomography
Lead sponsor: Studio Dentistico Associato Sivolella
Sponsor class: OTHER
First posted: 2023-10-27
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to one of two study arms, a test arm and a control arm, for the entire duration of the study.
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Pain and discomfort on VAS scale at the 4th postoperative day
timeFrame: First week after sinus lift procedure
Secondary outcomes:
measure: Times for surgical procedure
timeFrame: During sinus lift procedure
measure: Soft tissue healing after sinus lift
timeFrame: 10 days and 40 days after sinus lift procedure
measure: Sinus lift related complications
timeFrame: During sinus lift procedure, 1, 10 and 40 days from procedure.
measure: Graft healing after a 6 months period
timeFrame: 6 months after implant procedure
Other outcomes:
measure: Bone quality
timeFrame: During implant insertion
measure: ISQ and RFA
timeFrame: During implant insertion, 12 months after sinus lift (prosthetic loading), 24 months after sinus lift
measure: Insertion torque
timeFrame: During implant insertion
measure: Peri-implant marginal bone
timeFrame: During implant insertion, 12 months after sinus lift (prosthetic loading), 24 months after sinus lift
Locations:
city: Padova
country: Italy
facility: Studio Dentistico Associato Graiff e Sivolella
Study officials:
affiliation: Studio Dentistico Associato Sivolella
name: Stefano Sivolella, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
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