Clinical Evaluation of Two Types of Transalveolar Sinus Floor Elevation

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Evaluation of Modified Transalveolar Sinus Floor Elevation and Osteotome Sinus Floor Elevation in Posterior Maxillae

Conditions
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Dental Implant, Sinus Floor Augmentation

Intervention / Treatment
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* Device: traditional TSFE
* Procedure: bone grafting materials
* Device: TSFE by DASK drills
* Procedure: without bone grafting materials


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who is more than 18 years old; 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 systemic diseases as diabetes, hypertension and so on; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TSFE using osteotomes with bone grafting<br>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. | Device: traditional TSFE<br>* The TSFE procedure is performed by osteotomes (Straumann AG, Basel, Switzland) and mallet as the traditional ways.<br>Procedure: bone grafting materials<br>* The bone substitute is placed into the siuns under the membrane before the implant placement<br>|
| Experimental: TSFE using osteotomes without bone grafting<br>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. | Device: traditional TSFE<br>* The TSFE procedure is performed by osteotomes (Straumann AG, Basel, Switzland) and mallet as the traditional ways.<br>Procedure: without bone grafting materials<br>* The bone substitute will not be placed into the sinus before the implant placement.<br>|
| Experimental: modified TSFE with bone grafting<br>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. | Procedure: bone grafting materials<br>* The bone substitute is placed into the siuns under the membrane before the implant placement<br>Device: TSFE by DASK drills<br>* 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.<br>|
| Experimental: modified TSFE without bone grafting<br>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. | Device: TSFE by DASK drills<br>* 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.<br>Procedure: without bone grafting materials<br>* The bone substitute will not be placed into the sinus before the implant placement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental implants, Trans-alveolar sinus floor elevation, Bone grafting