Influence of Two Different Flap Designs for Sinus Floor Elevation

NCT03272100 | Completed DMC

• 1 other identifier: MSL001
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 2

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.

Conditions

Bone Involvement in Diseases Classified Elsewhere

Keywords

lateral approach; bone augmentation; sinus lift; flap

Outcome Measures

Primary Outcomes (1)

• height of augmented bone obtained

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

  6 months

Secondary Outcomes (2)

• Duration of the surgery

  1 day

• Post surgical patient's discomfort

  2 weeks

Study Arms (2)

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

Procedure: flap

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

Procedure: flap

Interventions

flap PROCEDURE

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

Also known as: surgical approach, Sinus augmentation

control side ( standard flap); test side ( horizontal flap)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

all the involved patients were edentulous in the maxillary posterior area , bilaterally, with a residual bone heigh of less then 4 mm; for this reason they required a surgical bone reconstruction for implant placement.

You may qualify if:

• 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

You may not qualify if:

• history of systemic diseases that would contraindicate surgical treatment

Sponsors & Collaborators

• University of Firenze and Siena, Napoli, Italy: lead

Study Sites (2)

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

Siena, 53100, Italy

Location

Tuscan School of Dentistry

Siena, 53100, Italy

Location

MeSH Terms

Interventions

Surgical Flaps; Sinus Floor Augmentation

Intervention Hierarchy (Ancestors)

Surgically-Created Structures; Equipment and Supplies; Oral Surgical Procedures; Surgical Procedures, Operative; Bone Transplantation; Orthopedic Procedures; Dentistry

Study Officials

• marco ferrari, clinical director

  tuscan school of dental medicine, university of Firenze and Siena

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: August 24, 2017
• First Posted: September 5, 2017
• Study Start: April 1, 2013
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: September 5, 2017

Record last verified: 2017-09

Locations

IT (2)