Sinus Lift With Hydroxyapatite Nano Particles Versus Tenting Technique

June 5, 2017 updated by: Hossam Khaled Shehata Faraag, Cairo University

Schneiderian Membrane Elevation and Augmentation With Hydroxyapatite Nano Particles [ Nano Streams ] Versus Graft Less Tenting Technique With Simultaneous Implant Placement: Randomized Clinical Trial

twenty recruited patients indicated for sinus augmentation and immediate implant placement will be divided into two groups (10 in each of the two groups), to compare bone formation and implant stability after shneiderian membrane elevation and augmentation with Hydroxyapatite Nano particles [Nanostreams] or augmentation with graft less tenting technique with simultaneous implant placement.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with atrophic maxilla and pneumatization of the maxillary sinus with residual bone height at least 5mm of residual ridge as per MISCH criteria
  • Both sexes

Exclusion Criteria:

  • Sinus pathology
  • Heavy smokers more than 20 cigarettes per day
  • Patients with systemic disease that may affect normal healing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sinus lift implant placement Hydroxyapatite Nano particles
shneiderian membrane elevation and augmentation with Hydroxyapatite Nano particles [Nanostreams] with simultaneous implant placement
Procedure: sinus lift implant placement Hydroxyapatite Nano particles
shneiderian membrane elevation and augmentation with Hydroxyapatite Nano particles with simultaneous implant placement
Active Comparator: sinus lift implant placement tenting
shneiderian membrane elevation and augmentation with graft less tenting technique with simultaneous implant placement
Procedure: sinus lift implant placement tenting
shneiderian membrane elevation and augmentation with graft less tenting technique with simultaneous implant placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient satisfaction
Time Frame: 7 days post operative
evaluation of post operative complications in terms of pain and edema using patient pain chart
7 days post operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
implant stability
Time Frame: will be measured intra-operative after implant insertion and will be measured one more time 6 months after the first operation at the time of implant exposure
measurement of the implant stability using osstell device
will be measured intra-operative after implant insertion and will be measured one more time 6 months after the first operation at the time of implant exposure
height of bone gain or loss around the implant
Time Frame: 6 months post operative
two cone beam CT will be taken for the patients, one immediate post operative and the other 6 months post-operative then the amount of bone gained or loss will be assessed by superimposing the same section in the two cone beam CT
6 months post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

May 19, 2017

First Submitted That Met QC Criteria

June 5, 2017

First Posted (Actual)

June 6, 2017

Study Record Updates

Last Update Posted (Actual)

June 6, 2017

Last Update Submitted That Met QC Criteria

June 5, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • cebc.cairo university

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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