Osteotome sinus floor elevation with or without grafting: a 3-year randomized controlled clinical trial

J Clin Periodontol. 2013 Apr;40(4):396-403. doi: 10.1111/jcpe.12066. Epub 2013 Feb 21.

Abstract

Aims: To evaluate the clinical and radiographic results of dental implant placed using osteotome sinus floor elevation (OSFE) with and without simultaneous grafting.

Materials & methods: Forty-five patients were randomly assigned into two groups: Group1: OSFE with deproteinized bovine bone mineral (DBBM) mixed with autogenous bone chips, and Group2: OSFE without grafting. The endo-sinus bone gain (ESBG) was assessed on radiographs at 6, 12, 24, 36 months following surgery as primary outcome measurement. Implant survivals and marginal bone loss (MBL) were assessed as secondary outcome measurements.

Results: Twenty-one implants in Group1 and 20 implants in Group2 were analysed. The residual bone height (RBH) was 4.63 ± 1.31 mm in average (4.67 ± 1.18 mm for Group1 and 4.58 ± 1.47 mm for Group2). The 3-year cumulative survival rates of implants were 95.2% for Group1 and 95.0% for Group2. The ESBG in Group1 reduced from 5.66 ± 0.99 mm at 6 months to 3.17 ± 1.95 mm at 36 months, whereas the ESBG in Group2 increased from 2.06 ± 1.01 mm at 6 months to 3.07 ± 1.68 mm at 36 months. The MBL after 3 years was 1.33 ± 0.46 mm in Group1 and 1.38 ± 0.23 mm in Group2.

Conclusions: OSFE and simultaneous implant installation with and without grafting both resulted in predictable results. The application of grafting materials has no significant advantage in terms of clinical success.

Trial registration: ClinicalTrials.gov NCT01619956.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Alveolar Bone Loss / diagnostic imaging
  • Alveolar Bone Loss / etiology
  • Bone Regeneration*
  • Bone Substitutes
  • Bone Transplantation* / methods
  • Chi-Square Distribution
  • Dental Implantation, Endosseous / adverse effects
  • Dental Implantation, Endosseous / methods*
  • Dental Prosthesis, Implant-Supported
  • Dental Restoration Failure
  • Double-Blind Method
  • Female
  • Humans
  • Jaw, Edentulous, Partially / surgery
  • Male
  • Maxillary Sinus / diagnostic imaging
  • Maxillary Sinus / surgery
  • Middle Aged
  • Osteotomy / instrumentation
  • Radiography
  • Sinus Floor Augmentation / instrumentation*
  • Sinus Floor Augmentation / methods*
  • Treatment Outcome
  • Young Adult

Substances

  • Bone Substitutes

Associated data

  • ClinicalTrials.gov/NCT01619956