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OpenTrials
Completed

NCT Number: NCT02117882

Minimally Invasive Lateral Approach for Sinus Augmentation: a Split-mouth Randomized Clinical Trial.

It is assumed that the minimally invasive lateral approach and the traditional lateral sinus lift procedure will result in better outcomes in terms of height of augmented bone.

It is also assumed that the minimally invasive lateral approach will reduce surgical complications and patient's discomfort in comparison with a traditional lateral sinus lift procedure.

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Key information

Conditions

Bone Involvement in Diseases Classified Elsewhere

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Siena, 53100, Italy

About this study

16 patients edentulous in maxillary posterior area will be treated with a bilateral sinus lift procedure.

Once a patient will be enrolled in the study impressions will be taken. After the wax-up, a radiographic stent will be prepared. Special attention will be given to position radio-opaque references in the positions where the implants will be inserted according to a prosthodontic guided insertion. Pre-surgical CT scan will be executed after placing the stent in its proper position in patient's mouth. After that, if no surgical contra-indications will be detected at CT evaluation, patients will be enrolled for surgical interventions.

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( not completely edentulous).
  • - 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

Primary outcomes

  1. height of augmented bone

    Time frame: 6 months

Secondary outcomes

  1. post surgical patient's discomfort

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

University of Firenze and Siena, Napoli, Italy

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 21, 2014
Registry last updated
Apr 21, 2014

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.

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