Dental Implants Clinical Trial
Official title:
Osteotome Sinus Floor Elevation With or Without Grafting: a Randomized Controlled Study
NCT number | NCT01619956 |
Other study ID # | 663-2009 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2010 |
Est. completion date | March 2012 |
Verified date | May 2019 |
Source | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 45 |
Est. completion date | March 2012 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | Department of Oral and Maxillo-facial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | ITI International Team for Implantology, Switzerland, National Natural Science Foundation of China, Shanghai Municipal Science and Technology Commission |
China,
Brägger 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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Pjetursson BE, Ignjatovic D, Matuliene G, Brägger 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. — View Citation
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. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Surgical and post-surgical complications and discomfort | 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" |
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