NCT03445039

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 2, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 26, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2020

Completed
Last Updated

February 26, 2018

Status Verified

February 1, 2018

Enrollment Period

2.1 years

First QC Date

January 25, 2018

Last Update Submit

February 19, 2018

Conditions

Dental ImplantSinus Floor Augmentation

Keywords

Dental implants, Trans-alveolar sinus floor elevation, Bone grafting

Outcome Measures

Primary Outcomes (26)

  • 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 Outcomes (5)

  • sulcus bleeding around the implant

    26 weeks after the implant placement

  • dental plaque around the implant

    26 weeks after the implant placement

  • other complications

    through study completion, up to 1 year

  • sulcus bleeding around the implant

    52 weeks after the implant placement

  • dental plaque around the implant

    52 weeks after the implant placement

Study Arms (4)

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.

Device: traditional TSFEProcedure: bone grafting materials

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.

Device: traditional TSFEProcedure: without bone grafting materials

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.

Procedure: bone grafting materialsDevice: TSFE 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.

Device: TSFE by DASK drillsProcedure: without bone grafting materials

Interventions

traditional TSFEDEVICE

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

TSFE using osteotomes with bone graftingTSFE using osteotomes without bone grafting
bone grafting materialsPROCEDURE

The bone substitute is placed into the siuns under the membrane before the implant placement

TSFE using osteotomes with bone graftingmodified TSFE with bone grafting
TSFE by DASK drillsDEVICE

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.

modified TSFE with bone graftingmodified TSFE without bone grafting
without bone grafting materialsPROCEDURE

The bone substitute will not be placed into the sinus before the implant placement.

TSFE using osteotomes without bone graftingmodified TSFE without bone grafting

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University, Hospital of stomatology, the first clinical division

Beijing, China

RECRUITING

Related Publications (9)

  • Tatum H Jr. Maxillary and sinus implant reconstructions. Dent Clin North Am. 1986 Apr;30(2):207-29.

    PMID: 3516738BACKGROUND

  • 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.

    PMID: 7994726BACKGROUND

  • 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.

    PMID: 21356405BACKGROUND

  • 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.

    PMID: 27031637BACKGROUND

  • 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.

    PMID: 18724853RESULT

  • 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.

    PMID: 18724852RESULT

  • 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.

    PMID: 26315564RESULT

  • 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.

    PMID: 28853214RESULT

  • 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.

    PMID: 30217227DERIVED

Study Officials

  • Feng Liu, Dr

    Peking University hospital of stomatology, the first clinical division

    STUDY DIRECTOR

Central Study Contacts

Xu Zhao, Dr

CONTACT

086 13331169917zhaoxu_@hotmail.com

Wei Gao, Dr

CONTACT

086 13810359034godwin060407@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinician

Study Record Dates

First Submitted

January 25, 2018

First Posted

February 26, 2018

Study Start

December 2, 2017

Primary Completion

December 25, 2019

Study Completion

December 25, 2020

Last Updated

February 26, 2018

Record last verified: 2018-02

Locations

CN(1)