NCT04659720

Brief Summary

Clinical evaluation of stability of dental implant placed simultaneously with closed sinus lifting using hydraulic lift technique versus summer's 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
20

participants targeted

Target at below P25 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 27, 2020

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 9, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

December 9, 2020

Status Verified

December 1, 2020

Enrollment Period

9 months

First QC Date

November 19, 2020

Last Update Submit

December 2, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Implant stability evaluation

    Evaluation of implant stability after closed sinus lifting in posterior edentulous maxilla using osteotome technique versus hydraulic lift technique

    Immediately after surgery

Secondary Outcomes (1)

  • Patient satisfaction evaluation

    Immediately after surgery

Study Arms (2)

summers' osteotome technique for closed sinus lift

ACTIVE COMPARATOR

Implant stability will be evaluated after closed sinus lift using summer's osteotome technique in posterior edentulous maxilla

Device: Hydrolic lifter device

Patient satisfaction evaluation after closed sinus lifting using summers' osteotome technique

ACTIVE COMPARATOR

* Will be assessed numerically using a patient satisfaction chart . * Time of assessment: immediately after surgery

Behavioral: Patient satisfaction evalution using hydraulic lifter device

Interventions

evaluation of implant stability after closed sinus lifting by hydraulic lift technique using hydraulic lifter device

summers' osteotome technique for closed sinus lift

patients satisfaction will be evaluated numerically after using hydraulic lift technique by hydraulic lifter device for closed sinus lifting in posterior edentulous maxilla

Patient satisfaction evaluation after closed sinus lifting using summers' osteotome technique

Eligibility Criteria

Age20 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 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 parafunctional 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

Cairo, Egypt

Location

Study Officials

  • Hassan Abdelghany, PHD

    Assoc.professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.professor in maxillo facial surgery

Study Record Dates

First Submitted

November 19, 2020

First Posted

December 9, 2020

Study Start

October 27, 2020

Primary Completion

August 1, 2021

Study Completion

November 1, 2021

Last Updated

December 9, 2020

Record last verified: 2020-12

Locations