Influence of Two Different Flap Designs for Sinus Floor Elevation

Study Overview
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Brief Summary
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It is assumed that the reduction of the flap dimension could provide a reduction of surgical time, post surgical complications and patient's discomfort when compared with the traditional surgical approach.

Detailed Description
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16 edentulous patients in maxillary posterior area were treated with a bilateral sinus lift procedure. Once enrolled in the study impressions were realised and the radiographic stent prepared, with radio-opaque references fixed in the positions where the implants should be inserted. Pre-surgical CT scan was executed after placing the stent in its proper position in patient's mouth. If no surgical contra-indications were detected at CT evaluation, patients were involved in the study.

Official Title
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Influence of Two Different Flap Designs for Sinus Floor Elevation. A Split-mouth Randomised Controlled Clinical Trial

Conditions
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Bone Involvement in Diseases Classified Elsewhere

Intervention / Treatment
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* Procedure: flap


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient edentulous in the maxillary posterior area on both left and right side residual bone height in the maxillary premolar and molar region less than 4mm Exclusion Criteria: history of systemic diseases that would contraindicate surgical treatment

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| test side ( horizontal flap)<br>Horizontal incision was realised in alveolar mucosa, in order to obtain the exposure of the lateral wall of the maxillary sinus, thus accessing the sinus cavity | Procedure: flap<br>* after flap incision , the sinus cavity was opened and then the membrane raised up<br>* Other names: Sinus augmentation;|
| control side ( standard flap)<br>Trapezoidal flap was realised, using a crestal incision and two deep vertical incisions extended in the fornix to expose the lateral wall of the maxillary sinus | Procedure: flap<br>* after flap incision , the sinus cavity was opened and then the membrane raised up<br>* Other names: Sinus augmentation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| height of augmented bone obtained | the height of the gained bone was recorded by using the control CT scan, realized after 6 months of follow up | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of the surgery | both total and partial times of different surgical steps were recorded | 1 day | 
| Post surgical patient's discomfort | all patients were asked to fill out a VAS scale, graduated from 1 (minimal pain ) to 10 ( maximum pain) | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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flap, lateral approach, bone augmentation, sinus lift