Osteotome Sinus Floor Elevation With or Without Grafting

Summary

The osteotome sinus floor elevation (OSFE) technique has been proved to be a predictable procedure for successful implant placement in posterior maxillae with limited bone height under sinus. OSFE is considered to be minimal invasive and minimal traumatic while having a limitation with regard to the residual bone height. According to the consensus conference in 1996, OSFE technique without bone grafting should be limited to RBH ranging from 7mm to 9mm. However, recent studies reported favorable results even with RBH of around 4mm. Moreover, there is still controversy regarding the necessity of a grafting material in order to maintain the space for new bone formation. Spontaneous bone formation was observed for OSFE without grafting by some researches.

Due to the lack of randomized controlled trial (RCTs), there is still no clear guideline for implant therapy in posterior maxillae with limited bone height. Neither is there any evidence to recommend or contraindicate the application of grafting materials in combination with OSFE.

The present RCT is aimed to evaluate the clinical success of OSFE with RBH of 2mm to 8 mm and to study whether the application of grafting material in combination with OSFE will be more favorable. The hypothesis is that the application of simultaneous grafting has no significant advantage in terms of clinical success. Spontaneous bone formation can be observed with implants placed using OSFE without grafting.

45 systemically healthy adults consecutively admitted for oral implant therapy will be randomly assigned to 2 test groups. Only one implant system will be used to minimize the implant-originated influencing factors. Bio-Oss® will be chosen as the bone substitute as it is currently the typical xenograft available. Autogenous bone will be also used as it is deemed as 'gold standard' for bone graft materials.

A panoramic radiograph and cone-beam CT should be taken to assess the pretreatment bone height under sinus. For T1 group, the autogenous bone chips harvested during the drilling procedure will be mixed up with Bio-Oss®. And the mixture is placed into the 'socket' by osteotomes when elevating the sinus membrane until the final depth. For T2 group, no grafting materials will be used. The subjects will be recalled for follow-up visits at 3 months, 6 months, 1 year, 2 years, 3 years,5years and 10 years after surgery for clinical and radiographic examination. Implant protrusion length, endo-sinus bone gain and crestal bone level will be measured on the radiographs using specialized software. ANOVA will be performed for the success rates of the 2 groups. Descriptive statistics will be used for the radiographic parameters.

The present study is aimed to provide preliminary evidence for an important clinical question that whether OSFE is predictable and reliable with RBH of less than 6mm and whether the application of grafting materials is necessary for this indication.

Conditions

• Dental Implants
• Sinus Floor Augmentation
• Bone Remodeling

Interventions

DEVICE

SLA dental implants

Dental implant with surface modification.

PROCEDURE

Osteotome sinus floor elevation

After locating the implant position by a round bur, the pilot drilling was performed to the depth approximately 1-2 mm away from the sinus floor boundary according to the depth taken from the pre-surgical radiograph. The cortical part of the implant bed was further widened to either 3.5mm for 4.1mm implants or 4.2mm for 4.8mm implants. Then the elevation of the maxillary sinus was achieved and developed using osteotome (Straumann Osteotome Kit, Straumann AG, Waldenburg, Switzerland) by light malleting to create a "greenstick" fracture on the compact bone of sinus floor and to increase diameters gradually till the final depth. The sinus membrane was tested again for any perforation by Valsalva manoeuvre.

PROCEDURE

Bone grafting

the autogenous bone chips harvested during the drilling procedure was mixed up with Bio-Oss® in approximately 1: 4 ratio. And the mixture was placed into the 'socket' by osteotomes when elevating the sinus membrane until the final depth.

Sponsors & Collaborators

• ITI International Team for Implantology, Switzerland

  collaborator OTHER

• Shanghai Municipal Science and Technology Commission

  collaborator OTHER_GOV

• National Natural Science Foundation of China

  collaborator OTHER_GOV

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

  lead OTHER

Principal Investigators

• Hongchang Lai · Department of Oral and Maxillo-facial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-01-31

Primary Completion

2011-12-31

Completion

2012-03-31

Countries

• China

Study Locations