Clinical Evaluation of Two Types of Transalveolar Sinus Floor Elevation
NCT ID: NCT03445039
Last Updated: 2018-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2017-12-02
2020-12-25
Brief Summary
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Methods/Design: 120 adult patients who fit the inclusion criterions are being recruited from the first clinical division, School and Hospital of Peking University (Beijing, China). All the patients are assigned into four groups according a table of random numbers. Participants receive 1) TSFE using osteotomes with bone grafting; 2) TSFE using osteotomes without bone grafting; 3) modified TSFE with bone grafting; and 4) modified TSFE without bone grafting. The clinical operators will be concealed with the assignment until the beginning of surgical procedures. In a one year follow up period, implant survival rates, complications, implant stability, bone remodeling around the implant and patient-reported outcome (visual analogue scale for intraoperative discomfort and postoperative pain) are observed and documented. The implant stability is gauged by the resonance frequency analysis for 7 times (2, 4,8,12,16,26,52 weeks). And the bone remodeling is observed and compared by CT scan.
Discussion: The result of the trial will support a better decision making in atrophy posterior maxilla when implant placement is needed. If favorable, the use of the modified TSFE would achieve as ideal outcome as the traditional TSFE but with less trauma and postoperative discomforts. Besides, whether the bone graft procedure is necessary for the TSFE will also be discussed.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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TSFE using osteotomes with bone grafting
The patients in this group will receive transalveolar sinus floor elevation with osteotomes and mallet. The bone substitute is placed in this group.The interventions in the arm are bone grafting and the TSFE will be performed by osteotomes.
traditional TSFE
The TSFE procedure is performed by osteotomes (Straumann AG, Basel, Switzland) and mallet as the traditional ways.
bone grafting materials
The bone substitute is placed into the siuns under the membrane before the implant placement
TSFE using osteotomes without bone grafting
The patients in this group will receive transalveolar sinus floor elevation with osteotomes and mallet. The bone substitute will not be placed in this group.The intervention in the arm is the TSFE will be performed by osteotomes.
traditional TSFE
The TSFE procedure is performed by osteotomes (Straumann AG, Basel, Switzland) and mallet as the traditional ways.
without bone grafting materials
The bone substitute will not be placed into the sinus before the implant placement.
modified TSFE with bone grafting
The patients in this group will receive modified transalveolar sinus floor elevation with the Dask drills. The cortical plate of the sinus floor is grinded or removed by the dome like drills. And the membrane is elevated by the surgical instruments. The bone substitute is placed before the implant placement.Interventions in the arm are bone grafting and the TSFE will be performed by dask drills.
bone grafting materials
The bone substitute is placed into the siuns under the membrane before the implant placement
TSFE by DASK drills
The TSFE procedure is performed by DASK(Dentium Advanced Surgical Kits) drills (Dentium, Korea), the residual cortical plate of the sinus floor is grinded by the drills.
modified TSFE without bone grafting
The patients in this group will receive modified transalveolar sinus floor elevation with the Dask drills. The cortical plate of the sinus floor is grinded or removed by the dome like drills. And the membrane is elevated by the surgical instruments. The bone substitute will not be placed in this group.The intervention in the arm is the TSFE will be performed by dask drills.
TSFE by DASK drills
The TSFE procedure is performed by DASK(Dentium Advanced Surgical Kits) drills (Dentium, Korea), the residual cortical plate of the sinus floor is grinded by the drills.
without bone grafting materials
The bone substitute will not be placed into the sinus before the implant placement.
Interventions
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traditional TSFE
The TSFE procedure is performed by osteotomes (Straumann AG, Basel, Switzland) and mallet as the traditional ways.
bone grafting materials
The bone substitute is placed into the siuns under the membrane before the implant placement
TSFE by DASK drills
The TSFE procedure is performed by DASK(Dentium Advanced Surgical Kits) drills (Dentium, Korea), the residual cortical plate of the sinus floor is grinded by the drills.
without bone grafting materials
The bone substitute will not be placed into the sinus before the implant placement.
Eligibility Criteria
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Inclusion Criteria
* patients have lost a single tooth or several teeth in the posterior area of the maxilla, the tooth has/have been extracted for more than three months;
* The residual bone height was between 3mm to 6mm;
* The width of the alveolar ridge could contain the implant with standard diameter;
* The general and local status of patient are suitable for implant placement and sinus floor elevation;
* The patient who is willing to sign the informed consent and to follow the experimental follow-up rules.
Exclusion Criteria
* Uncontrolled local diseases as periodontal disease or muco- cutaneous disease;
* Heavy smoker (more than 10 cigarettes /day)
* Patients who is suffering rhinitis, sinusitis; or rather large cyst is found in the maxillary sinus
* The bone density of the maxillary posterior region is too poor to maintain the initial stability of the implant
* The target of the implant site once received implant therapy or bone grafting
* Patient with psychogenia or incapable to understand and obey the doctors' instruction.
18 Years
70 Years
ALL
Yes
Sponsors
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Peking University
OTHER
Responsible Party
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Xu Zhao
clinician
Principal Investigators
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Feng Liu, Dr
Role: STUDY_DIRECTOR
Peking University hospital of stomatology, the first clinical division
Locations
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Peking University, Hospital of stomatology, the first clinical division
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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References
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Tatum H Jr. Maxillary and sinus implant reconstructions. Dent Clin North Am. 1986 Apr;30(2):207-29.
Summers RB. The osteotome technique: Part 3--Less invasive methods of elevating the sinus floor. Compendium. 1994 Jun;15(6):698, 700, 702-4 passim; quiz 710.
Lozada JL, Goodacre C, Al-Ardah AJ, Garbacea A. Lateral and crestal bone planing antrostomy: a simplified surgical procedure to reduce the incidence of membrane perforation during maxillary sinus augmentation procedures. J Prosthet Dent. 2011 Mar;105(3):147-53. doi: 10.1016/S0022-3913(11)60020-6.
French D, Nadji N, Shariati B, Hatzimanolakis P, Larjava H. Survival and Success Rates of Dental Implants Placed Using Osteotome Sinus Floor Elevation Without Added Bone Grafting: A Retrospective Study with a Follow-up of up to 10 Years. Int J Periodontics Restorative Dent. 2016;36 Suppl:s89-97. doi: 10.11607/prd.2191.
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.
Pjetursson 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.
Markovic A, Misic T, Calvo-Guirado JL, Delgado-Ruiz RA, Janjic B, Abboud M. Two-Center Prospective, Randomized, Clinical, and Radiographic Study Comparing Osteotome Sinus Floor Elevation with or without Bone Graft and Simultaneous Implant Placement. Clin Implant Dent Relat Res. 2016 Oct;18(5):873-882. doi: 10.1111/cid.12373. Epub 2015 Aug 28.
Caban J, Fermergard R, Abtahi J. Long-term evaluation of osteotome sinus floor elevation and simultaneous placement of implants without bone grafts: 10-Year radiographic and clinical follow-up. Clin Implant Dent Relat Res. 2017 Dec;19(6):1023-1033. doi: 10.1111/cid.12530. Epub 2017 Aug 29.
Zhao X, Gao W, Liu F. Clinical evaluation of modified transalveolar sinus floor elevation and osteotome sinus floor elevation in posterior maxillae: study protocol for a randomized controlled trial. Trials. 2018 Sep 14;19(1):489. doi: 10.1186/s13063-018-2879-x.
Other Identifiers
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modified maxillary sinus lift
Identifier Type: -
Identifier Source: org_study_id
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