Influence of Two Different Flap Designs for Sinus Floor Elevation

Completed

• Conditions: Bone Involvement in Diseases Classified Elsewhere
• Interventions: Procedure: flap

• Registration Number: NCT03272100
• Lead Sponsor: University of Firenze and Siena, Napoli, Italy

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-04-01
• Primary Completion: 2017-08-01
• Study Completion: 2017-08-01
• Study First Submitted: 2017-08-24
• Status Verified: 2017-09
• Study First Submitted QC: 2017-09-01
• Last Update Submitted: 2017-09-01
• Study First Posted: 2017-09-05
• Last Update Posted: 2017-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control side ( standard flap)	flap	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
test side ( horizontal flap)	flap	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

Primary Outcome Measures

Name	Time	Method
height of augmented bone obtained	6 months	the height of the gained bone was recorded by using the control CT scan, realized after 6 months of follow up

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Siena University, Department of Periodontology, Policlinico Le Scotte Siena.; 🇮🇹 Siena, Italy

Tuscan School of Dentistry; 🇮🇹 Siena, Italy