NCT03732885

Brief Summary

To investigate the efficacy of osseodensification drills (Densah bure) as a new closed sinus lift tool and to compare the effect of it in bone gaine versus traditional osteotomes.

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
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 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

First Submitted

Initial submission to the registry

October 30, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2019

Completed
Last Updated

November 7, 2018

Status Verified

November 1, 2018

Enrollment Period

6 months

First QC Date

October 30, 2018

Last Update Submit

November 5, 2018

Conditions

Implant Tissue Failure

Keywords

SinusStabilityBone gainOsseodensification

Outcome Measures

Primary Outcomes (1)

  • implant stability

    measurement of implant stability using the Ostell

    6 months after surgery

Secondary Outcomes (1)

  • bone gain

    6 months after surgery

Study Arms (2)

densah burs drilling group

EXPERIMENTAL

maxillary sinus floor elevation during implant placement using Densah burs

Device: densah burs osseo densification drills

Summers osteotomes

EXPERIMENTAL

maxillary sinus floor elevation during implant placement using Summer's Osteotomes

Device: Summer's Osteotomes

Interventions

densah burs osseo densification drillsDEVICE

maxillary sinus floor elevation during implant placement using Densah burs

densah burs drilling group
Summer's OsteotomesDEVICE

maxillary sinus floor elevation during implant placement using Summer's Osteotomes

Summers osteotomes

Eligibility Criteria

Age25 Years - 55 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohaib M Elsheikh

Cairo, 11311, Egypt

Location

MeSH Terms

Conditions

Fistula

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Sohaib M Elsheikh, masters

CONTACT

00201222500517alzamzamy44@hotmail.com

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
principal investigator

Study Record Dates

First Submitted

October 30, 2018

First Posted

November 7, 2018

Study Start

November 1, 2018

Primary Completion

April 15, 2019

Study Completion

July 15, 2019

Last Updated

November 7, 2018

Record last verified: 2018-11

Locations

EG(1)