Skip to main content
OpenTrials
Completed

NCT Number: NCT03272100

Influence of Two Different Flap Designs for Sinus Floor Elevation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bone Involvement in Diseases Classified Elsewhere

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Siena University, Department of Periodontology, Policlinico Le Scotte Siena., Siena, Italy

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

flap

Procedure

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

Other names: surgical approach, Sinus augmentation

Primary outcomes

  1. height of augmented bone obtained

    Time frame: 6 months

    the height of the gained bone was recorded by using the control CT scan, realized after 6 months of follow up

Secondary outcomes

  1. Duration of the surgery

    Time frame: 1 day

    both total and partial times of different surgical steps were recorded

  2. Post surgical patient's discomfort

    Time frame: 2 weeks

    all patients were asked to fill out a VAS scale, graduated from 1 (minimal pain ) to 10 ( maximum pain)

Sponsors and collaborators

Lead sponsor

University of Firenze and Siena, Napoli, Italy

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Sep 5, 2017
Registry last updated
Sep 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.