Osteotome Sinus Floor Elevation With or Without Grafting

NCT01619956 | Completed DMC

• 1 other identifier: 663-2009
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

dental implants; osteotome sinus floor elevation; survival rate; sinus grafting; bone remodeling; RCT; radiographic analysis

Outcome Measures

Primary Outcomes (6)

• Endo-sinus bone gain at 6-month

  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.

  6-month follow-up

• Endo-sinus bone gain at 12-month

  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.

  12-month follow-up

• Endo-sinus bone gain at 24-month

  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.

  24-month follow-up

• Endo-sinus bone gain at 36-month

  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.

  36-month follow-up

• Endo-sinus bone gain at 60-month

  Radiographic assessment was conducted on periapical radiographs at every follow-up visit using paralleling technique. The endo-sinus bone gain of bothgroups were assessed on radiography.

  60-month follow-up

• Endo-sinus bone gain at 10-year

  Radiographic assessment was conducted on periapical radiographs at every follow-up visit using paralleling technique. The endo-sinus bone gain of bothgroups were assessed on radiography.

  10-year follow-up

Secondary Outcomes (1)

• Surgical and post-surgical complications and discomfort

  3 hours after surgery

Study Arms (2)

OSFE with grafting

EXPERIMENTAL

OSFE with grafting (autogenous bone chips+xenograft material with a ratio of 1:4)

Device: SLA dental implants; Procedure: Osteotome sinus floor elevation; Procedure: Bone grafting

OSFE without grafting

ACTIVE COMPARATOR

OSFE without grafting. No grafting materials or autogenous bone chips were used.

Device: SLA dental implants; Procedure: Osteotome sinus floor elevation

Interventions

SLA dental implants DEVICE

Dental implant with surface modification.

Also known as: Straumann, Straumann AG, Waldenburg, Switzerland

OSFE with grafting; OSFE without grafting

Osteotome sinus floor elevation PROCEDURE

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.

Also known as: osteotome (Straumann Osteotome Kit, Straumann AG, Waldenburg, Switzerland)

OSFE with grafting; OSFE without grafting

Bone grafting PROCEDURE

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.

Also known as: Bio-Oss®, Geistlich Pharma AG, Wolhusen, Switzerland.

OSFE with grafting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead
• ITI International Team for Implantology, Switzerland: collaborator
• Shanghai Municipal Science and Technology Commission: collaborator
• National Natural Science Foundation of China: collaborator

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200011, China

Location

Related Publications (9)

• Tan WC, Lang NP, Zwahlen M, Pjetursson BE. A systematic review of the success of sinus floor elevation and survival of implants inserted in combination with sinus floor elevation. Part II: transalveolar technique. J Clin Periodontol. 2008 Sep;35(8 Suppl):241-54. doi: 10.1111/j.1600-051X.2008.01273.x.

  PMID: 18724853 BACKGROUND

• Lai HC, Zhuang LF, Lv XF, Zhang ZY, Zhang YX, Zhang ZY. Osteotome sinus floor elevation with or without grafting: a preliminary clinical trial. Clin Oral Implants Res. 2010 May;21(5):520-6. doi: 10.1111/j.1600-0501.2009.01889.x. Epub 2010 Mar 11.

  PMID: 20337666 BACKGROUND

• Lai HC, Zhang ZY, Wang F, Zhuang LF, Liu X. Resonance frequency analysis of stability on ITI implants with osteotome sinus floor elevation technique without grafting: a 5-month prospective study. Clin Oral Implants Res. 2008 May;19(5):469-75. doi: 10.1111/j.1600-0501.2007.01501.x. Epub 2008 Mar 26.

  PMID: 18371099 BACKGROUND

• Pjetursson BE, Ignjatovic D, Matuliene G, Bragger U, Schmidlin K, Lang NP. Transalveolar maxillary sinus floor elevation using osteotomes with or without grafting material. Part II: Radiographic tissue remodeling. Clin Oral Implants Res. 2009 Jul;20(7):677-83. doi: 10.1111/j.1600-0501.2009.01721.x.

  PMID: 19515059 BACKGROUND

• Bragger U, Gerber C, Joss A, Haenni S, Meier A, Hashorva E, Lang NP. Patterns of tissue remodeling after placement of ITI dental implants using an osteotome technique: a longitudinal radiographic case cohort study. Clin Oral Implants Res. 2004 Apr;15(2):158-66. doi: 10.1111/j.1600-0501.2004.00988.x.

  PMID: 15008927 BACKGROUND

• Tetsch J, Tetsch P, Lysek DA. Long-term results after lateral and osteotome technique sinus floor elevation: a retrospective analysis of 2190 implants over a time period of 15 years. Clin Oral Implants Res. 2010 May;21(5):497-503. doi: 10.1111/j.1600-0501.2008.01661.x.

  PMID: 20443802 BACKGROUND

• Nedir R, Nurdin N, Vazquez L, Szmukler-Moncler S, Bischof M, Bernard JP. Osteotome sinus floor elevation technique without grafting: a 5-year prospective study. J Clin Periodontol. 2010 Nov;37(11):1023-8. doi: 10.1111/j.1600-051X.2010.01610.x. Epub 2010 Aug 24.

  PMID: 20735796 BACKGROUND

• Qian SJ, Mo JJ, Si MS, Qiao SC, Shi JY, Lai HC. Long-term outcomes of osteotome sinus floor elevation with or without bone grafting: The 10-year results of a randomized controlled trial. J Clin Periodontol. 2020 Aug;47(8):1016-1025. doi: 10.1111/jcpe.13260. Epub 2020 May 6.

  PMID: 31976567 DERIVED

• Si MS, Zhuang LF, Gu YX, Mo JJ, Qiao SC, Lai HC. 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.

  PMID: 23425152 DERIVED

MeSH Terms

Interventions

Bone Transplantation; Bio-Oss

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Orthopedic Procedures; Surgical Procedures, Operative; Transplantation

Study Officials

• Hongchang Lai

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Oral and Maxillo-facial Implantology Department

Study Record Dates

• First Submitted: June 9, 2012
• First Posted: June 15, 2012
• Study Start: January 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: March 1, 2012
• Last Updated: May 16, 2019

Record last verified: 2019-05

Locations

CN (1)