Influence of Two Different Flap Designs for Sinus Floor Elevation

NCT ID: NCT03272100

Last Updated: 2017-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-01

Study Completion Date

2017-08-01

Brief Summary

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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

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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.

Conditions

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Bone Involvement in Diseases Classified Elsewhere

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

flap

Intervention Type PROCEDURE

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

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

flap

Intervention Type PROCEDURE

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

Interventions

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flap

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

Intervention Type PROCEDURE

Other Intervention Names

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surgical approach Sinus augmentation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Firenze and Siena, Napoli, Italy

OTHER

Sponsor Role lead

Responsible Party

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nicola baldini

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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marco ferrari, clinical director

Role: STUDY_CHAIR

tuscan school of dental medicine, university of Firenze and Siena

Locations

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

Siena, , Italy

Site Status

Tuscan School of Dentistry

Siena, , Italy

Site Status

Countries

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Italy

Other Identifiers

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MSL001

Identifier Type: -

Identifier Source: org_study_id

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