NCT04648514

Brief Summary

Radiographic evaluation of bone height gain with dental implant placed simultaneously with closed sinus lifting using hydraulic lift technique versus summers' osteotome technique in posterior edentulous maxilla (RCT)

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
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 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

October 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

December 1, 2020

Status Verified

November 1, 2020

Enrollment Period

11 months

First QC Date

November 15, 2020

Last Update Submit

November 23, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Amount of bone height change

    Evaluation of the amount of bone height change radiographically after closed sinus lift simultaneously with implant placement using hydraulic lift technique versus summers' osteotome technique in posterior edentulous maxilla

    6 months

Secondary Outcomes (1)

  • Patient satisfaction numerical questionnaire

    6 months

Study Arms (2)

Using of bone osteotomes for closed sinus lifting

ACTIVE COMPARATOR

Using of summers' osteotome technique by bone osteotomes for closed sinus lifting then evaluation the amount of bone height gain will be done radiographically (by panorama and CBCT) after implant placement in posterior edentulous maxilla .

Procedure: Using of hydraulic lifter device for closed sinus lifting

Patient satisfaction evaluation after using bone osteotomes

ACTIVE COMPARATOR

Evaluation of patient satisfaction numerically will be done after using summers' osteotome technique by bone osteotomes for closed sinus lifting in posterior edentulous maxilla

Behavioral: patient satisfaction evaluation after using hydraulic lifter device

Interventions

Using of recent closed minimally invasive technique (hydraulic left technique) by hydraulic lifter device for closed sinus lifting then evaluation of the amount of bone height gain will be done radiographically (by panorama and CBCT) after implant placement for patients with posterior edentulous maxilla .

Using of bone osteotomes for closed sinus lifting

Evaluation of patient satisfaction numerically will be done after using hydraulic lift technique by hydraulic lifter device for closed sinus lifting in posterior edentulous maxilla

Patient satisfaction evaluation after using bone osteotomes

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Edentulous patients in the maxillary posterior region .
  • Patients in need to fixed restorations in posterior region .
  • Patients with a healthy systemic conditions.(Apparently medically free)
  • Patients with adequate inter-arch space for placement of the prosthetic part of the implant .
  • Patients who had approximately 5-8 mm of available bone height between crest of bone and floor of sinus
  • Both sexes.
  • Patients with Good oral hygiene
  • Patients more than 20 years old
  • Cooperative and motivated patients

You may not qualify if:

  • Patients with local pathological defects related to posterior maxilla .
  • Heavy smokers.
  • Abnormal habits that may alter results such as alcoholism or parafuctional habits .
  • Patients with systemic diseases that may affect normal healing.
  • Patients with psychiatric problem
  • Patients with history of recent radiation therapy to the head and neck area .
  • Patients with aggressive periodontitis .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Giza, 12613, Egypt

Location

Study Officials

  • Hassan Abdelghany, PHD

    Assoc.professor of oral and maxillofacial surgery

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 15, 2020

First Posted

December 1, 2020

Study Start

October 1, 2020

Primary Completion

August 30, 2021

Study Completion

September 30, 2021

Last Updated

December 1, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations