Non Grafted Maxillary Sinus Floor Elevation With Implant Placement Versus the Use of Short Endosseous Implants

Non Grafted Maxillary Sinus Floor Elevation With Simultaneous Implant Placement Versus the Use of Short Endosseous Implants

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

Study Overview

• Status: Unknown
• Conditions: Marginal Bone Loss; Primary Stability of Implants
• Intervention / Treatment: Procedure: Non grafted maxillary sinus floor elevation with simultaneous implant placement; Procedure: using short dental implants for posterior atrophic maxilla

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Ahmed Maher Mansour
    • Contact: ahmed maher mansour, BDS; Phone Number: 00201092955447; Email: a7mad.maher10@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Non grafted maxillary sinus floor elevation with implant pacem	Procedure: Non grafted maxillary sinus floor elevation with simultaneous implant placement; lateral window for sinus elevation ,membrane elevation ,implant placement , membrane for window closure
Experimental: using short dental implants for posterior atrophic maxilla	Procedure: using short dental implants for posterior atrophic maxilla; placement of short dental implant with bone height below 8mm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
primary stability	measuring primary stability using osstel	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
marginal bone loss	measuring marginal bone loss using cone beam ct	6 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2018
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: September 2, 2018
• First Submitted That Met QC Criteria: September 5, 2018
• First Posted (Actual): September 7, 2018

Study Record Updates

• Last Update Posted (Actual): September 7, 2018
• Last Update Submitted That Met QC Criteria: September 5, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: cairo university 99

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No