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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03272100
Enrollment
16
Registered
2017-09-05
Start date
2013-04-01
Completion date
2017-08-01
Last updated
2017-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Involvement in Diseases Classified Elsewhere

Keywords

lateral approach, bone augmentation, sinus lift, flap

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.

Interventions

PROCEDUREflap

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

Sponsors

University of Firenze and Siena, Napoli, Italy
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
height of augmented bone obtained6 monthsthe height of the gained bone was recorded by using the control CT scan, realized after 6 months of follow up

Secondary

MeasureTime frameDescription
Duration of the surgery1 dayboth total and partial times of different surgical steps were recorded
Post surgical patient's discomfort2 weeksall patients were asked to fill out a VAS scale, graduated from 1 (minimal pain ) to 10 ( maximum pain)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026