Implant Stability Using Densah Bur Versus Expander

August 2, 2018 updated by: Ahmed Hisham Mahmoud Riad, Cairo University

Evaluation of Implant's Primary Stability Using Densah Bur Versus Expander in Patients With Missing Maxillary Premolar (A Randomized Clinical Trial)

evaluating use of Densah bur in thin ridge enhance implant's primary stability when compared to screw expander.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

25 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with partial edentulous maxillary premolar area with crestal thickness ranging from 4 to 6 mm.
  • Age 25 - 50 years.
  • No intraoral soft tissue or hard tissue pathosis.
  • No systemic condition contraindicating implant placement.

Exclusion Criteria:

  • Ridges thickness less than 4 mm.
  • Coexisting vertical defect.
  • Heavy smokers (more than 20 cigarettes per day).
  • Patients with systemic disease that may affect normal healing.
  • Patient with psychiatric problems.
  • History of radiation therapy to the head and neck region.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Expansion by Densah bur
  • Scrubbing and draping of the patient in a standard fashion for intra oral procedures followed by local anesthesia administration to the patient.
  • A mid crestal flap will be reflected.
  • For both groups the implant manufacturer's pilot drill will be used to perform a standard osteotomy of 10 mm depth.
  • Sequential use of Densah bur under copious irrigation.
  • An implant of 3.9*10 mm will be inserted.
  • Smart peg will be placed on implant and Osstell will be used to record ISQ.
  • Healing collars will be placed on implants.
  • Flap will be prepared for closure and suturing.
Other: Expansion
non invasive technique to increase thickness of thin ridge
Active Comparator: Expander

Scrubbing and draping of the patient in a standard fashion for intra oral procedures followed by local anesthesia administration to the patient.

  • A mid crestal flap will be reflected.
  • For both groups the implant manufacturer's pilot drill will be used to perform a standard osteotomy of 10 mm depth.
  • Sequential use of screw expanders.
  • An implant of 3.9*10 mm will be inserted.
  • Smart peg will be placed on implant and Osstell will be used to record ISQ.
  • Healing collars will be placed on implants.
  • Flap will be prepared for closure and suturing.
Other: Expansion
non invasive technique to increase thickness of thin ridge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
implant's primary stability
Time Frame: intraoperative at time of surgery
After implant placement, Implant stability will be measured by Ostell device.
intraoperative at time of surgery
implant's primary stability
Time Frame: Implant stability will be measured at second week
Implant stability will be measured by Ostell device.
Implant stability will be measured at second week
implant's primary stability
Time Frame: Implant stability will be measured at fourth week
Implant stability will be measured by Ostell device.
Implant stability will be measured at fourth week
implant's primary stability
Time Frame: Implant stability will be measured at sixth week
Implant stability will be measured by Ostell device.
Implant stability will be measured at sixth week
implant's primary stability
Time Frame: Implant stability will be measured at eighth week
Implant stability will be measured by Ostell device.
Implant stability will be measured at eighth week

Collaborators and Investigators

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

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

September 1, 2018

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

July 23, 2018

First Submitted That Met QC Criteria

August 2, 2018

First Posted (Actual)

August 3, 2018

Study Record Updates

Last Update Posted (Actual)

August 3, 2018

Last Update Submitted That Met QC Criteria

August 2, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • Expansion by densah bur

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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