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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
The TSFE procedure is performed by osteotomes (Straumann AG, Basel, Switzland) and mallet as the traditional ways.
The bone substitute is placed into the siuns under the membrane before the implant placement
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.
The bone substitute will not be placed into the sinus before the implant placement.
Peking University, Hospital of stomatology, the first clinical division
Beijing, China
RECRUITINGimplant survival rate
whether the implant has osseointegrated and functional
Time frame: 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)
Time frame: 2 weeks after implant placement
implant stability
the implant stability is gauged by the RFA( resonance frequency analysis)
Time frame: 4 weeks after the implant placement
implant stability
the implant stability is gauged by the RFA( resonance frequency analysis)
Time frame: 8 weeks after the implant placement
implant stability
the implant stability is gauged by the RFA( resonance frequency analysis)
Time frame: 12 weeks after the implant placement
implant stability
the implant stability is gauged by the RFA( resonance frequency analysis)
Time frame: 16 weeks after the implant placement
implant stability
the implant stability is gauged by the RFA( resonance frequency analysis)
Time frame: 26 weeks after the implant placement
implant stability
the implant stability is gauged by the RFA( resonance frequency analysis)
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 14 days after the surgery
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
Time frame: 26 weeks after the implant placement
dental plaque around the implant
measure whether there is dental plaque around the implant
Time frame: 26 weeks after the implant placement
other complications
including post-operative infection, bleeding in the nostril,hematoma, stuffy nose and benign paroxysmal positional vertigo
Time frame: 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
Time frame: 52 weeks after the implant placement
dental plaque around the implant
measure whether there is dental plaque around the implant
Time frame: 52 weeks after the implant placement
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