Osteotome Sinus Floor Elevation With or Without Grafting

This study has been completed.
Sponsor:
Collaborators:
ITI International Team for Implantology, Switzerland
Shanghai Municipal Science and Technology Commission
National Natural Science Foundation of China
Information provided by (Responsible Party):
Hongchang Lai, Shanghai 9th People's Hospital
ClinicalTrials.gov Identifier:
NCT01619956
First received: June 9, 2012
Last updated: June 14, 2012
Last verified: June 2012
  Purpose

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 6 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.

90 systemically healthy adults consecutively admitted for oral implant therapy will be randomly assigned to 3 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 an intra-oral radiograph 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, only Bio-Oss® will be placed into the 'socket' by osteotomes when elevating the sinus membrane until the final depth. No grafting materials will be used for T3 group. The subjects will be recalled for follow-up visits at 3 months, 6 months, 1 year, 2 years and 3 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 3 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.


Condition Intervention
Dental Implants
Sinus Floor Augmentation
Bone Remodeling
Device: SLA dental implants
Procedure: Osteotome sinus floor elevation
Procedure: Bone grafting

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Osteotome Sinus Floor Elevation With or Without Grafting: a Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Shanghai 9th People's Hospital:

Primary Outcome Measures:
  • Endo-sinus bone gain at 6-month [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
    Radiographic assessment was conducted on periapical radiographs at every follow-up visit using paralleling technique. The endo-sinus bone gain of both groups were assessed on radiography.

  • Endo-sinus bone gain at 12-month [ Time Frame: 12-month follow-up ] [ Designated as safety issue: No ]
    Radiographic assessment was conducted on periapical radiographs at every follow-up visit using paralleling technique. The endo-sinus bone gain of both groups were assessed on radiography.

  • Endo-sinus bone gain at 24-month [ Time Frame: 24-month follow-up ] [ Designated as safety issue: No ]
    Radiographic assessment was conducted on periapical radiographs at every follow-up visit using paralleling technique. The endo-sinus bone gain of both groups were assessed on radiography.

  • Endo-sinus bone gain at 36-month [ Time Frame: 36-month follow-up ] [ Designated as safety issue: No ]
    Radiographic assessment was conducted on periapical radiographs at every follow-up visit using paralleling technique. The endo-sinus bone gain of both groups were assessed on radiography.


Secondary Outcome Measures:
  • Surgical and post-surgical complications and discomfort [ Time Frame: 3 hours after surgery ] [ Designated as safety issue: Yes ]

    The sinus membrane perforation was evaluated by the Valsalva manoeuvre during surgery. Other surgical and post-surgical complications including infection, haemorrhage, nasal bleeding, benign paroxysmal positional vertigo (BPPV), blocked nose were also recorded.

    The pain and discomfort reported by the patients were evaluated by visual analogue scales (VAS) in which 0 indicated "no pain or no discomfort" and 100 indicated "intolerable pain or maximum discomfort"



Enrollment: 92
Study Start Date: January 2010
Study Completion Date: March 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OSFE with grafting
OSFE with grafting (autogenous bone chips+xenograft material with a ratio of 1:4)
Device: SLA dental implants
Dental implant with surface modification.
Other Name: Straumann, Straumann AG, Waldenburg, Switzerland
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.
Other Name: osteotome (Straumann Osteotome Kit, Straumann AG, Waldenburg, Switzerland)
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.
Other Name: Bio-Oss®, Geistlich Pharma AG, Wolhusen, Switzerland.
Active Comparator: OSFE without grafting
OSFE without grafting. No grafting materials or autogenous bone chips were used.
Device: SLA dental implants
Dental implant with surface modification.
Other Name: Straumann, Straumann AG, Waldenburg, Switzerland
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.
Other Name: osteotome (Straumann Osteotome Kit, Straumann AG, Waldenburg, Switzerland)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • partial edentulism in the maxillary posterior region for at least 6 months from tooth loss
  • residual bone height ranged from 2mm to 8mm (measured on pre-surgical radiograph)
  • sufficient bone width in edentulous region
  • systemic and local condition compatible with implant placement and sinus floor elevation
  • willing to provide informed consent and capable to comply the study protocol.

Exclusion Criteria:

  • uncontrolled diabetes mellitus or other systemic disorders
  • uncontrolled periodontal conditions, endodontic lesions or other oral disorders
  • heavy smokers (≥ 10 cigarettes per day)
  • rhinitis or sinusitis
  • insufficient residual bone quality to achieve implant stability
  • previous implant installation or bone grafting at the surgical site
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01619956

Locations
China, Shanghai
Department of Oral and Maxillo-facial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, Shanghai, China, 200011
Sponsors and Collaborators
Shanghai 9th People's Hospital
ITI International Team for Implantology, Switzerland
Shanghai Municipal Science and Technology Commission
National Natural Science Foundation of China
Investigators
Principal Investigator: Hongchang Lai Department of Oral and Maxillo-facial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hongchang Lai, Chair of Oral and Maxillo-facial Implantology Department, Shanghai 9th People's Hospital
ClinicalTrials.gov Identifier: NCT01619956     History of Changes
Other Study ID Numbers: 663-2009
Study First Received: June 9, 2012
Last Updated: June 14, 2012
Health Authority: China: Science and Technology Commission of Shanghai Municipality

Keywords provided by Shanghai 9th People's Hospital:
dental implants
osteotome sinus floor elevation
survival rate
sinus grafting
bone remodeling
RCT
radiographic analysis

ClinicalTrials.gov processed this record on October 23, 2014