NCT04662749

Brief Summary

The contour of maxillary sinus matters in osteotome sinus elevation. So does the implant intruding angle between the axis of the implant and the tangent line of the sinus floor contour. The investigators have been engaged in studying the relationship between the outcome of bone formation and the intruding angle, which could guide our clinical decision-making.

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
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 10, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2021

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2021

Completed
Last Updated

February 23, 2021

Status Verified

December 1, 2020

Enrollment Period

1.1 years

First QC Date

November 25, 2020

Last Update Submit

February 20, 2021

Conditions

Partial-edentulismOsteotome Sinus Lift

Keywords

osteotome sinus liftendosinus bone gainsinus floor configurationintruding angle

Outcome Measures

Primary Outcomes (1)

  • endosinus bone change

    endosinus bone change after osteotome sinus elevation without grafting

    from the time of performing the implanting surgery to the latest recalling period, accessed up to 100 months

Study Arms (3)

concave group

the group whose level of sinus floor is lower than both of the adjacent teeth

angle group

the group whose level of sinus floor is lower than one of the adjacent teeth and higher than the other one of the adjacent teeth

flat group

the group whose level of sinus floor is similar to both of the adjacent teeth

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who visited Guanghua Hospital of Stomatology, Sun Yat-Sen University from July 2006 to August 2018.

You may qualify if:

  • Patients with residual bone height \>4mm and osteotome sinus elevation together with simultaneous implant placement without grafting

You may not qualify if:

  • Smokers or patients with systemic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of Stomatology, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

Central Study Contacts

Feilong Deng, PhD

CONTACT

+8620 8386 2537dengfl@mail.sysu.edu.cn

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of Implantology, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

November 25, 2020

First Posted

December 10, 2020

Study Start

February 16, 2020

Primary Completion

March 20, 2021

Study Completion

March 26, 2021

Last Updated

February 23, 2021

Record last verified: 2020-12

Locations

CN(1)