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Background: Implant placement in the posterior maxilla is always troubled by the insufficient bone volume. Trans-alveolar sinus floor elevation (TSFE) has been proven a predictable surgical procedure to increase the bone height in the posterior maxilla. However, questions as the necessity of the bone grafting is necessary during the sinus lift and could the TSFE be performed when the residual bone height is below 5mm are still being debated. Besides, high-quality evidence on comparing the clinical outcome of transalveolar sinus floor elevation with osteotome and modified sinus floor elevation with crestal non-cutting drills is limited.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TSFE using osteotomes with bone grafting | Experimental | 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. |
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| TSFE using osteotomes without bone grafting | Experimental | 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. |
|
| modified TSFE with bone grafting | Experimental | 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. |
|
| modified TSFE without bone grafting | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| traditional TSFE | Device | The TSFE procedure is performed by osteotomes (Straumann AG, Basel, Switzland) and mallet as the traditional ways. |
|
| Measure | Description | Time Frame |
|---|---|---|
| implant survival rate | whether the implant has osseointegrated and functional | the implant status will be inspected and calculated at 1 year revisit |
| implant stability | the implant stability is gauged by the RFA( resonance frequency analysis) | 2 weeks after implant placement |
| implant stability | the implant stability is gauged by the RFA( resonance frequency analysis) | 4 weeks after the implant placement |
| implant stability | the implant stability is gauged by the RFA( resonance frequency analysis) | 8 weeks after the implant placement |
| implant stability | the implant stability is gauged by the RFA( resonance frequency analysis) | 12 weeks after the implant placement |
| implant stability | the implant stability is gauged by the RFA( resonance frequency analysis) | 16 weeks after the implant placement |
| implant stability | the implant stability is gauged by the RFA( resonance frequency analysis) | 26 weeks after the implant placement |
| implant stability |
| Measure | Description | Time Frame |
|---|---|---|
| sulcus bleeding around the implant | the sulcus bleeding index is used to measure whether there is bleeding when the dental prob is inserte the sulcus around the implant site | 26 weeks after the implant placement |
| dental plaque around the implant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xu Zhao, Dr | Contact | 086 13331169917 | zhaoxu_@hotmail.com | |
| Wei Gao, Dr | Contact | 086 13810359034 | godwin060407@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Feng Liu, Dr | Peking University hospital of stomatology, the first clinical division | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University, Hospital of stomatology, the first clinical division | Recruiting | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3516738 | Background | Tatum H Jr. Maxillary and sinus implant reconstructions. Dent Clin North Am. 1986 Apr;30(2):207-29. | |
| 7994726 | Background | 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. |
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All of the patients will be divided into four groups by using randomization tables. The assignment will be concealed from the clinical operators until the beginning of implant surgery. The outcome examiners will be kept blinded to the assignment.
|
| bone grafting materials | Procedure | The bone substitute is placed into the siuns under the membrane before the implant placement |
|
| TSFE by DASK drills | Device | 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 | Procedure | The bone substitute will not be placed into the sinus before the implant placement. |
|
the implant stability is gauged by the RFA( resonance frequency analysis)
| 52 weeks after the implant placement |
| marginal bone remodeling around the implant | use CBCT to access the marginal bone changes between the 26 weeks after the implant placement and baseline (the day the implant is placed). | 26 weeks after the implant placement |
| marginal bone remodeling around the implant | use CBCT to access the marginal bone changes between the 52 weeks after the implant placement and baseline (the day the implant is placed). | 52 weeks after the implant placement |
| post operative pain accessed by the patient | The post operative pain is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal "No pain" and "worst imaginable pain". The patient will mark on the line to represent their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. | 1 day after the surgery |
| post operative pain accessed by the patient | The post operative pain is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal "No pain" and "worst imaginable pain". The patient will mark on the line to represent their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. | 2 days after the surgery |
| post operative pain accessed by the patient | The post operative pain is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal "No pain" and "worst imaginable pain". The patient will mark on the line to represent their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. | 3 days after the surgery |
| post operative pain accessed by the patient | The post operative pain is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal "No pain" and "worst imaginable pain". The patient will mark on the line to represent their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. | 4 days after the surgery |
| post operative pain accessed by the patient | The post operative pain is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal "No pain" and "worst imaginable pain". The patient will mark on the line to represent their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. | 5 days after the surgery |
| post operative pain accessed by the patient | The post operative pain is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal "No pain" and "worst imaginable pain". The patient will mark on the line to represent their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. | 6 days after the surgery |
| post operative pain accessed by the patient | The post operative pain is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal "No pain" and "worst imaginable pain". The patient will mark on the line to represent their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. | 7 days after the surgery |
| post operative pain accessed by the patient | The post operative pain is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal "No pain" and "worst imaginable pain". The patient will mark on the line to represent their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. | 14 days after the surgery |
| post operative swelling accessed by the patient | The post operative swelling is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal "No swelling" and "worst imaginable swelling". The patient will mark on the line to represent their swelling intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no swelling" anchor and the patient's mark, providing a range of scores from 0-100. | 1 day after the surgery |
| post operative swelling accessed by the patient | The post operative swelling is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal "No swelling" and "worst imaginable swelling". The patient will mark on the line to represent their swelling intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no swelling" anchor and the patient's mark, providing a range of scores from 0-100. | 2 days after the surgery |
| post operative swelling accessed by the patient | The post operative swelling is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal "No swelling" and "worst imaginable swelling". The patient will mark on the line to represent their swelling intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no swelling" anchor and the patient's mark, providing a range of scores from 0-100. | 3 days after the surgery |
| post operative swelling accessed by the patient | The post operative swelling is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal "No swelling" and "worst imaginable swelling". The patient will mark on the line to represent their swelling intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no swelling" anchor and the patient's mark, providing a range of scores from 0-100. | 4 days after the surgery |
| post operative swelling accessed by the patient | The post operative swelling is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal "No swelling" and "worst imaginable swelling". The patient will mark on the line to represent their swelling intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no swelling" anchor and the patient's mark, providing a range of scores from 0-100. | 5 days after the surgery |
| post operative swelling accessed by the patient | The post operative swelling is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal "No swelling" and "worst imaginable swelling". The patient will mark on the line to represent their swelling intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no swelling" anchor and the patient's mark, providing a range of scores from 0-100. | 6 days after the surgery |
| post operative swelling accessed by the patient | The post operative swelling is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal "No swelling" and "worst imaginable swelling". The patient will mark on the line to represent their swelling intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no swelling" anchor and the patient's mark, providing a range of scores from 0-100. | 7 days after the surgery |
| post operative swelling accessed by the patient | The post operative swelling is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal "No swelling" and "worst imaginable swelling". The patient will mark on the line to represent their swelling intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no swelling" anchor and the patient's mark, providing a range of scores from 0-100. | 14 days after the surgery |
measure whether there is dental plaque around the implant
| 26 weeks after the implant placement |
| other complications | including post-operative infection, bleeding in the nostril,hematoma, stuffy nose and benign paroxysmal positional vertigo | through study completion, up to 1 year |
| sulcus bleeding around the implant | the sulcus bleeding index is used to measure whether there is bleeding when the dental prob is inserte the sulcus around the implant site | 52 weeks after the implant placement |
| dental plaque around the implant | measure whether there is dental plaque around the implant | 52 weeks after the implant placement |
| 21356405 | Background | 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. |
| 27031637 | Background | 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. |
| 18724853 | Result | 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. |
| 18724852 | Result | 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. |
| 26315564 | Result | 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. |
| 28853214 | Result | 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. |
| 30217227 | Derived | 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. |