Clinical Success of Short Dental Implants Alone and Standard Dental Implants Combined With Osteotome Sinus Floor Elevation in Posterior Maxillae
1 other identifier
interventional
225
1 country
1
Brief Summary
The aim of this study is to determine the clinical success of short implants (6mm) alone and standard implants (10mm) combined with sinus floor elevation in atrophic maxilla.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2015
CompletedFirst Posted
Study publicly available on registry
January 29, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedMay 16, 2019
May 1, 2019
2 years
January 19, 2015
May 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Implants survival rate
Survival rate is defined by percentage of dental implants that remained in situ with or without modifications.
1 year after implant placement
Secondary Outcomes (3)
Marginal bone loss
1 year after implant placement
Complication rate
1 year after implant placement
Patient-reported outcome (100-mm visual analogue scale (VAS)
10 minutes after implant surgery
Study Arms (2)
Short implants group
EXPERIMENTALPatients receive short dental implants installation (6mm) without additional augmentation procedures.
Standard implants with OSFE group
OTHERPatients receive standard dental implants installation (10mm) combined with osteotome sinus floor elevation.
Interventions
Dental implants installation is a procedure to insert dental implants into alveolar bone.
Osteotomes with different diameters are specially-designed device to vertically increase the bone volume in atrophic maxilla.
Eligibility Criteria
You may qualify if:
- age≧18 years, partial edentulism in posterior maxilla for at least three months from tooth loss,
- residual bone height range from 6-8mm,
- sufficient bone width in edentulous region.
You may not qualify if:
- The patients will be excluded on the basis of:
- heavy smoker (\>10 cigarettes per days),
- uncontrolled diabetes mellitus or other systemic diseases,
- uncontrolled periodontal infection,
- insufficient bone quality to achieve implant stability and
- previous implant installation or bone grafting at surgical site.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jun-Yu Shi
Shanghai, Shanghai Municipality, 200011, China
Related Publications (7)
Mangano FG, Shibli JA, Sammons RL, Iaculli F, Piattelli A, Mangano C. Short (8-mm) locking-taper implants supporting single crowns in posterior region: a prospective clinical study with 1-to 10-years of follow-up. Clin Oral Implants Res. 2014 Aug;25(8):933-40. doi: 10.1111/clr.12181. Epub 2013 Apr 28.
PMID: 23621393BACKGROUNDLai HC, Si MS, Zhuang LF, Shen H, Liu YL, Wismeijer D. Long-term outcomes of short dental implants supporting single crowns in posterior region: a clinical retrospective study of 5-10 years. Clin Oral Implants Res. 2013 Feb;24(2):230-7. doi: 10.1111/j.1600-0501.2012.02452.x. Epub 2012 Apr 2.
PMID: 22469075BACKGROUNDTan 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: 18724853BACKGROUNDPjetursson BE, Tan WC, Zwahlen M, Lang NP. A systematic review of the success of sinus floor elevation and survival of implants inserted in combination with sinus floor elevation. J Clin Periodontol. 2008 Sep;35(8 Suppl):216-40. doi: 10.1111/j.1600-051X.2008.01272.x.
PMID: 18724852BACKGROUNDThoma DS, Haas R, Tutak M, Garcia A, Schincaglia GP, Hammerle CH. Randomized controlled multicentre study comparing short dental implants (6 mm) versus longer dental implants (11-15 mm) in combination with sinus floor elevation procedures. Part 1: demographics and patient-reported outcomes at 1 year of loading. J Clin Periodontol. 2015 Jan;42(1):72-80. doi: 10.1111/jcpe.12323. Epub 2014 Dec 26.
PMID: 25418606BACKGROUNDZhang XM, Shi JY, Gu YX, Qiao SC, Mo JJ, Lai HC. Clinical Investigation and Patient Satisfaction of Short Implants Versus Longer Implants with Osteotome Sinus Floor Elevation in Atrophic Posterior Maxillae: A Pilot Randomized Trial. Clin Implant Dent Relat Res. 2017 Feb;19(1):161-166. doi: 10.1111/cid.12435. Epub 2016 Jul 8.
PMID: 27389435DERIVEDShi JY, Gu YX, Qiao SC, Zhuang LF, Zhang XM, Lai HC. Clinical evaluation of short 6-mm implants alone, short 8-mm implants combined with osteotome sinus floor elevation and standard 10-mm implants combined with osteotome sinus floor elevation in posterior maxillae: study protocol for a randomized controlled trial. Trials. 2015 Jul 30;16:324. doi: 10.1186/s13063-015-0853-4.
PMID: 26223254DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
- Medical Doctor, Department of oral and maxillofacial implants
Study Record Dates
First Submitted
January 19, 2015
First Posted
January 29, 2015
Study Start
March 1, 2015
Primary Completion
March 1, 2017
Study Completion
March 1, 2017
Last Updated
May 16, 2019
Record last verified: 2019-05