Here is the design of a clinical trial:

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

Included conditions:
- Dental Implant
- Sinus Floor Augmentation

Study Armgroups:
- {'label': 'TSFE using osteotomes with bone grafting', 'type': 'EXPERIMENTAL', 'description': '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.', 'interventionNames': ['Device: traditional TSFE', 'Procedure: bone grafting materials']}
- {'label': 'TSFE using osteotomes without bone grafting', 'type': 'EXPERIMENTAL', 'description': '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.', 'interventionNames': ['Device: traditional TSFE', 'Procedure: without bone grafting materials']}
- {'label': 'modified TSFE with bone grafting', 'type': 'EXPERIMENTAL', 'description': '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.', 'interventionNames': ['Procedure: bone grafting materials', 'Device: TSFE by DASK drills']}
- {'label': 'modified TSFE without bone grafting', 'type': 'EXPERIMENTAL', 'description': '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.', 'interventionNames': ['Device: TSFE by DASK drills', 'Procedure: without bone grafting materials']}

Interventions:
- {'type': 'DEVICE', 'name': 'traditional TSFE', 'description': 'The TSFE procedure is performed by osteotomes (Straumann AG, Basel, Switzland) and mallet as the traditional ways.', 'armGroupLabels': ['TSFE using osteotomes with bone grafting', 'TSFE using osteotomes without bone grafting']}
- {'type': 'PROCEDURE', 'name': 'bone grafting materials', 'description': 'The bone substitute is placed into the siuns under the membrane before the implant placement', 'armGroupLabels': ['TSFE using osteotomes with bone grafting', 'modified TSFE with bone grafting']}
- {'type': 'DEVICE', 'name': 'TSFE by DASK drills', 'description': '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.', 'armGroupLabels': ['modified TSFE with bone grafting', 'modified TSFE without bone grafting']}
- {'type': 'PROCEDURE', 'name': 'without bone grafting materials', 'description': 'The bone substitute will not be placed into the sinus before the implant placement.', 'armGroupLabels': ['TSFE using osteotomes without bone grafting', 'modified TSFE without bone grafting']}

Primary Outcomes:
- {'measure': 'implant survival rate', 'description': 'whether the implant has osseointegrated and functional', 'timeFrame': 'the implant status will be inspected and calculated at 1 year revisit'}
- {'measure': 'implant stability', 'description': 'the implant stability is gauged by the RFA( resonance frequency analysis)', 'timeFrame': '2 weeks after implant placement'}
- {'measure': 'implant stability', 'description': 'the implant stability is gauged by the RFA( resonance frequency analysis)', 'timeFrame': '4 weeks after the implant placement'}
- {'measure': 'implant stability', 'description': 'the implant stability is gauged by the RFA( resonance frequency analysis)', 'timeFrame': '8 weeks after the implant placement'}
- {'measure': 'implant stability', 'description': 'the implant stability is gauged by the RFA( resonance frequency analysis)', 'timeFrame': '12 weeks after the implant placement'}
- {'measure': 'implant stability', 'description': 'the implant stability is gauged by the RFA( resonance frequency analysis)', 'timeFrame': '16 weeks after the implant placement'}
- {'measure': 'implant stability', 'description': 'the implant stability is gauged by the RFA( resonance frequency analysis)', 'timeFrame': '26 weeks after the implant placement'}
- {'measure': 'implant stability', 'description': 'the implant stability is gauged by the RFA( resonance frequency analysis)', 'timeFrame': '52 weeks after the implant placement'}
- {'measure': 'marginal bone remodeling around the implant', 'description': 'use CBCT to access the marginal bone changes between the 26 weeks after the implant placement and baseline (the day the implant is placed).', 'timeFrame': '26 weeks after the implant placement'}
- {'measure': 'marginal bone remodeling around the implant', 'description': 'use CBCT to access the marginal bone changes between the 52 weeks after the implant placement and baseline (the day the implant is placed).', 'timeFrame': '52 weeks after the implant placement'}
- {'measure': 'post operative pain accessed by the patient', 'description': '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.', 'timeFrame': '1 day after the surgery'}
- {'measure': 'post operative pain accessed by the patient', 'description': '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.', 'timeFrame': '2 days after the surgery'}
- {'measure': 'post operative pain accessed by the patient', 'description': '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.', 'timeFrame': '3 days after the surgery'}
- {'measure': 'post operative pain accessed by the patient', 'description': '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.', 'timeFrame': '4 days after the surgery'}
- {'measure': 'post operative pain accessed by the patient', 'description': '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.', 'timeFrame': '5 days after the surgery'}
- {'measure': 'post operative pain accessed by the patient', 'description': '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.', 'timeFrame': '6 days after the surgery'}
- {'measure': 'post operative pain accessed by the patient', 'description': '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.', 'timeFrame': '7 days after the surgery'}
- {'measure': 'post operative pain accessed by the patient', 'description': '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.', 'timeFrame': '14 days after the surgery'}
- {'measure': 'post operative swelling accessed by the patient', 'description': '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.', 'timeFrame': '1 day after the surgery'}
- {'measure': 'post operative swelling accessed by the patient', 'description': '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.', 'timeFrame': '2 days after the surgery'}
- {'measure': 'post operative swelling accessed by the patient', 'description': '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.', 'timeFrame': '3 days after the surgery'}
- {'measure': 'post operative swelling accessed by the patient', 'description': '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.', 'timeFrame': '4 days after the surgery'}
- {'measure': 'post operative swelling accessed by the patient', 'description': '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.', 'timeFrame': '5 days after the surgery'}
- {'measure': 'post operative swelling accessed by the patient', 'description': '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.', 'timeFrame': '6 days after the surgery'}
- {'measure': 'post operative swelling accessed by the patient', 'description': '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.', 'timeFrame': '7 days after the surgery'}
- {'measure': 'post operative swelling accessed by the patient', 'description': '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.', 'timeFrame': '14 days after the surgery'}

Please estimate the sample size based on the assumption: 
The significance level (α) is set at 0.05, the power of the test (β) is set at 90%, and the loss to follow-up rate is around 10%.
Sample size
        The sample size of the current trial is calculated based on the formula: n = 2(tÎ± + t1-Î²)2Ï2/Î´2. According to the preliminary experiment results and data analysis from currently published articles, the difference of the bone remodeling with and without bone grafting groups (Î´) is around 0.8 mm, the difference of the bone remodeling between the original TSFE groups and modified TSFE groups is around 0.5 mm, and the standard deviation in groups (Ï) is around 1 mm.
        Thus, if the inspection level (Î±) is set at 0.05 and the power of test (Î²) is set at 90%, then 27 participants will be required for each group. Given a loss to follow-up rate of around 10%, the study would be anticipated to require 30 participants for each group. As a result, this trial will require at least 120 participants in its current setup.