NCT03661957

Brief Summary

Assessment the need for sinus floor elevation when restoring atrophic posterior maxilla or it will be enough to use of short implant

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
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 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

September 1, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

September 7, 2018

Status Verified

September 1, 2018

Enrollment Period

3 months

First QC Date

September 2, 2018

Last Update Submit

September 5, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • primary stability

    measuring primary stability using osstel

    6 months

Secondary Outcomes (1)

  • marginal bone loss

    6 months

Study Arms (2)

Non grafted maxillary sinus floor elevation with implant pacem

ACTIVE COMPARATOR
Procedure: Non grafted maxillary sinus floor elevation with simultaneous implant placement

using short dental implants for posterior atrophic maxilla

EXPERIMENTAL
Procedure: using short dental implants for posterior atrophic maxilla

Interventions

lateral window for sinus elevation ,membrane elevation ,implant placement , membrane for window closure

Non grafted maxillary sinus floor elevation with implant pacem

placement of short dental implant with bone height below 8mm

using short dental implants for posterior atrophic maxilla

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with partially edentulous in the posterior area of the maxilla, with a residual ridge that allowed insertion of ≤8 mm length implants.
  • Both sexes.
  • No intraoral soft and hard tissue pathology
  • No systemic condition that contraindicate implant placement.

You may not qualify if:

  • Sinus pathology.
  • Heavy smokers more than 20 cigarettes per day.
  • Patients with systemic disease that may affect normal healing.
  • Psychiatric problems
  • Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site
  • Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Maher Mansour

Cairo, Egypt

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dentist-master student

Study Record Dates

First Submitted

September 2, 2018

First Posted

September 7, 2018

Study Start

September 1, 2018

Primary Completion

December 1, 2018

Study Completion

April 1, 2019

Last Updated

September 7, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will share

Locations