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Clinical Evaluation of Two Types of Transalveolar Sinus Floor Elevation

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ClinicalTrials.gov Identifier: NCT03445039
Recruitment Status : Recruiting
First Posted : February 26, 2018
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Xu Zhao, Peking University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Dental Implant Sinus Floor Augmentation Device: traditional TSFE Procedure: bone grafting materials Device: TSFE by DASK drills Procedure: without bone grafting materials Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Modified Transalveolar Sinus Floor Elevation and Osteotome Sinus Floor Elevation in Posterior Maxillae
Actual Study Start Date : December 2, 2017
Estimated Primary Completion Date : December 25, 2019
Estimated Study Completion Date : December 25, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Arm Intervention/treatment
Experimental: 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.
Device: traditional TSFE
The TSFE procedure is performed by osteotomes (Straumann AG, Basel, Switzland) and mallet as the traditional ways.

Procedure: bone grafting materials
The bone substitute is placed into the siuns under the membrane before the implant placement

Experimental: 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.
Device: traditional TSFE
The TSFE procedure is performed by osteotomes (Straumann AG, Basel, Switzland) and mallet as the traditional ways.

Procedure: without bone grafting materials
The bone substitute will not be placed into the sinus before the implant placement.

Experimental: 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.
Procedure: bone grafting materials
The bone substitute is placed into the siuns under the membrane before the implant placement

Device: 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.

Experimental: 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.
Device: 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.

Procedure: without bone grafting materials
The bone substitute will not be placed into the sinus before the implant placement.




Primary Outcome Measures :
  1. implant survival rate [ Time Frame: the implant status will be inspected and calculated at 1 year revisit ]
    whether the implant has osseointegrated and functional

  2. implant stability [ Time Frame: 2 weeks after implant placement ]
    the implant stability is gauged by the RFA( resonance frequency analysis)

  3. implant stability [ Time Frame: 4 weeks after the implant placement ]
    the implant stability is gauged by the RFA( resonance frequency analysis)

  4. implant stability [ Time Frame: 8 weeks after the implant placement ]
    the implant stability is gauged by the RFA( resonance frequency analysis)

  5. implant stability [ Time Frame: 12 weeks after the implant placement ]
    the implant stability is gauged by the RFA( resonance frequency analysis)

  6. implant stability [ Time Frame: 16 weeks after the implant placement ]
    the implant stability is gauged by the RFA( resonance frequency analysis)

  7. implant stability [ Time Frame: 26 weeks after the implant placement ]
    the implant stability is gauged by the RFA( resonance frequency analysis)

  8. implant stability [ Time Frame: 52 weeks after the implant placement ]
    the implant stability is gauged by the RFA( resonance frequency analysis)

  9. marginal bone remodeling around the implant [ Time Frame: 26 weeks after the implant placement ]
    use CBCT to access the marginal bone changes between the 26 weeks after the implant placement and baseline (the day the implant is placed).

  10. marginal bone remodeling around the implant [ Time Frame: 52 weeks after the implant placement ]
    use CBCT to access the marginal bone changes between the 52 weeks after the implant placement and baseline (the day the implant is placed).

  11. post operative pain accessed by the patient [ Time Frame: 1 day after the surgery ]
    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.

  12. post operative pain accessed by the patient [ Time Frame: 2 days after the surgery ]
    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.

  13. post operative pain accessed by the patient [ Time Frame: 3 days after the surgery ]
    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. post operative pain accessed by the patient [ Time Frame: 4 days after the surgery ]
    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.

  15. post operative pain accessed by the patient [ Time Frame: 5 days after the surgery ]
    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.

  16. post operative pain accessed by the patient [ Time Frame: 6 days after the surgery ]
    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.

  17. post operative pain accessed by the patient [ Time Frame: 7 days after the surgery ]
    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.

  18. post operative pain accessed by the patient [ Time Frame: 14 days after the surgery ]
    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.

  19. post operative swelling accessed by the patient [ Time Frame: 1 day after the surgery ]
    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.

  20. post operative swelling accessed by the patient [ Time Frame: 2 days after the surgery ]
    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.

  21. post operative swelling accessed by the patient [ Time Frame: 3 days after the surgery ]
    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.

  22. post operative swelling accessed by the patient [ Time Frame: 4 days after the surgery ]
    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.

  23. post operative swelling accessed by the patient [ Time Frame: 5 days after the surgery ]
    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.

  24. post operative swelling accessed by the patient [ Time Frame: 6 days after the surgery ]
    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.

  25. post operative swelling accessed by the patient [ Time Frame: 7 days after the surgery ]
    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.

  26. post operative swelling accessed by the patient [ Time Frame: 14 days after the surgery ]
    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.


Secondary Outcome Measures :
  1. sulcus bleeding around the implant [ Time Frame: 26 weeks after the implant placement ]
    the sulcus bleeding index is used to measure whether there is bleeding when the dental prob is inserte the sulcus around the implant site

  2. dental plaque around the implant [ Time Frame: 26 weeks after the implant placement ]
    measure whether there is dental plaque around the implant

  3. other complications [ Time Frame: through study completion, up to 1 year ]
    including post-operative infection, bleeding in the nostril,hematoma, stuffy nose and benign paroxysmal positional vertigo

  4. sulcus bleeding around the implant [ Time Frame: 52 weeks after the implant placement ]
    the sulcus bleeding index is used to measure whether there is bleeding when the dental prob is inserte the sulcus around the implant site

  5. dental plaque around the implant [ Time Frame: 52 weeks after the implant placement ]
    measure whether there is dental plaque around the implant



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03445039


Contacts
Contact: Xu Zhao, Dr 086 13331169917 zhaoxu_@hotmail.com
Contact: Wei Gao, Dr 086 13810359034 godwin060407@163.com

Locations
China
Peking University, Hospital of stomatology, the first clinical division Recruiting
Beijing, China
Contact: Feng Liu       Dentistliufeng@126.com   
Sponsors and Collaborators
Peking University
Investigators
Study Director: Feng Liu, Dr Peking University hospital of stomatology, the first clinical division

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Xu Zhao, clinician, Peking University
ClinicalTrials.gov Identifier: NCT03445039     History of Changes
Other Study ID Numbers: modified maxillary sinus lift
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xu Zhao, Peking University:
Dental implants, Trans-alveolar sinus floor elevation, Bone grafting