Influence of Two Different Flap Designs for Sinus Floor Elevation

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

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.

Study Overview

• Status: Completed
• Conditions: Bone Involvement in Diseases Classified Elsewhere
• Intervention / Treatment: Procedure: flap

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 Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• Italy
  • Siena, Italy, 53100
    • Siena University, Department of Periodontology, Policlinico Le Scotte Siena.
  • Siena, Italy, 53100
    • Tuscan School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

all the involved patients were edentulous in the maxillary posterior area , bilaterally, with a residual bone heigh of less then 4 mm; for this reason they required a surgical bone reconstruction for implant placement.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
test side ( horizontal 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	Procedure: flap; after flap incision , the sinus cavity was opened and then the membrane raised up; Other Names: surgical approach; Sinus augmentation
control side ( standard 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	Procedure: flap; after flap incision , the sinus cavity was opened and then the membrane raised up; Other Names: surgical approach; Sinus augmentation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Firenze and Siena, Napoli, Italy
• Investigators: Study Chair: marco ferrari, clinical director, tuscan school of dental medicine, university of Firenze and Siena

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2013
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: August 24, 2017
• First Submitted That Met QC Criteria: September 1, 2017
• First Posted (Actual): September 5, 2017

Study Record Updates

• Last Update Posted (Actual): September 5, 2017
• Last Update Submitted That Met QC Criteria: September 1, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: bone augmentation; lateral approach; sinus lift; flap
• Other Study ID Numbers: MSL001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No