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

Bone Involvement in Diseases Classified Elsewhere Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02117882
• Other study ID #: misfe
• Status: Completed
• Phase: N/A
• First received: April 16, 2014
• Last updated: April 16, 2014
• Start date: January 2013
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: University of Firenze and Siena, Napoli, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bone Involvement in Diseases Classified Elsewhere

Locations

Country	Name	City	State
Italy	Siena University, Department of Periodontology, Policlinico Le Scotte Siena.	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		6 months	Yes
Secondary	post surgical patient's discomfort		2 weeks	Yes