Influence of Two Different Flap Designs for Sinus Floor Elevation

Bone Involvement in Diseases Classified Elsewhere Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03272100
• Other study ID #: MSL001
• Status: Completed
• Phase: N/A
• First received: August 24, 2017
• Last updated: September 1, 2017
• Start date: April 1, 2013
• Est. completion date: August 1, 2017

Study information

• Verified date: September 2017
• Source: University of Firenze and Siena, Napoli, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 1, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Involvement in Diseases Classified Elsewhere

Intervention

Procedure:
• flap
after flap incision , the sinus cavity was opened and then the membrane raised up

Locations

Country	Name	City	State
Italy	Siena University, Department of Periodontology, Policlinico Le Scotte Siena.	Siena
Italy	Tuscan School of Dentistry	Siena

Sponsors (1)

Lead Sponsor	Collaborator
University of Firenze and Siena, Napoli, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Duration of the surgery	both total and partial times of different surgical steps were recorded	1 day
Secondary	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