Tunnel Flap vs Trapezoidal Flap for Lateral Sinus Lift

Study Overview
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Brief Summary
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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: Is the tunnel flap technique more suitable for lateral sinus lift than the trapezoidal flap technique in terms of post-operative symptoms? 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.

Official Title
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Tunnel Flap vs Trapezoidal Flap for Lateral Sinus Lift: A Prospective Randomized Study

Conditions
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Severe Atrophy of the Edentulous Maxilla

Intervention / Treatment
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* Procedure: Lateral Sinus Lift using tunnel flap technique
* Procedure: Lateral Sinus Lift using crestal incision flap


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tunnel flap design<br>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. | Procedure: Lateral Sinus Lift using tunnel flap technique<br>* 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.<br>|
| Active Comparator: Trapezioidal flap design<br>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. | Procedure: Lateral Sinus Lift using crestal incision flap<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and discomfort on VAS scale at the 4th postoperative day | Participants will record the subjective post-operative pain/discomfort on a daily VAS score (0 to 10) for the first 7 days, at the same time each day, on a specific form. The VAS is a horizontal ruler 10 cm long with the left end (0 cm) indicating no pain/discomfort at all and the right limit (10 cm) indicating the worst pain imaginable. Patients will be also asked to record the need for analgesics (including type and quantity). | First week after sinus lift procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Times for surgical procedure | Surgical intervention duration (minutes) recorded from incision to the last suture (T1). Times for sinus mucosa elevation (T2) and for sinus filling (T3) will be measured as well. | During sinus lift procedure | 
| Soft tissue healing after sinus lift | Soft tissue healing will be evaluated using the scoring reported by Lin SL et al., at two timepoints: at suture removal and at 30 days after suture removal control. Assessments of wound healing will include 6 scoring categories, namely erythema, exudate, epithelialization, mucosa color, wound contour, and distortion of mucosa. Each category is scored on a 3-point scale (0, 1, or 2) and a total score from 0 to 3 represents good healing, a score from 4 to 6 represents satisfactory healing, a score from 7 to 9 represents disturbance of healing, and a score from 10 to 12 represents poor healing | 10 days and 40 days after sinus lift procedure | 
| Sinus lift related complications | Possible complications will be evaluated at various timepoints. During the surgical procedure through direct observation (bleeding, sinus membrane perforation, infraorbital nerve injury, perforation of the flap). The day after surgery through a telephone call to the patient (bleeding, flap dehiscence, hematoma, pain). At suture removal control after 10 +/- days after surgery (pain, infections, sinusitis, bone graft displacement, neuropathy, wound dehiscence). At 30 days after suture removal control (pain, infections, sinusitis, bone graft displacement, neuropathy). | During sinus lift procedure, 1, 10 and 40 days from procedure. | 
| Graft healing after a 6 months period | A CBCT of the grafted area finalized to implants insertion planning will be taken after 6 months from the sinus lift. The parameters evaluated will be the final alveolar bone graft height calculated in correspondence of a line passing through the centre of the previous bone window; the presence of the contact between the bone graft and the medial or nasal wall of the sinus cavity; the regular distribution of the graft, intended as the presence of voids or displacements. Moreover a biopsy will be taken during implants insertion by means of a trefine. | 6 months after implant procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lateral sinus lift, Tunnel technique, Dental Implant, Patient Reported Outcome Measures, Bone Regeneration, Flap Design, Histology, Heterologous bone, Cone Beam Computed Tomography