Evaluation of Osseodensification Versus Osseodensification With Ridge Splitting in Horizontally Deficient Ridge

October 4, 2022 updated by: Eman Farouk Mohamed Hussein Elsobky, Ain Shams University

Evaluation of Osseodensification Versus Osseodensification With Ridge Splitting in Horizontally Deficient Ridge (A Randomized Clinical Study)

Osseodensification is a method of biomechanical bone preparation where specially designed burs increase density of bone as they expand an osteotomy. These osseodensifying burs combine advantages of osteotome bone preservation with the standard traditional drilling burs speed and tactile control. The investigators compared ridge splitting followed by osseodensification versus osseodensification in terms of buccolingual ridge expansion both clinically and radiographically.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Sixteen patients will be randomly allocated into two groups. Ridge splitting followed by osseodensification will be performed with simultaneous implant placement in group I.

Osseodensification will be performed with simultaneous implant placement in group II.

Alveolar ridge width and Implant stability will be assessed clinically. Alveolar ridge width and bone density will be assessed radiographically.

Study Type

Interventional

Enrollment (Anticipated)

16

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.

Study Contact

Study Contact Backup

  • Name: Yasmine E. Fouad, Lecturer

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

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients suffering from missing single or multiple maxillay anterior and /or premolar with at least 8 mm alveolar ridge height, with 4-6mm alveolar buccolingual (BL) ridge width.
  • Patients should be systemically healthy.
  • Patients available during follow up periods.

Exclusion Criteria:

  • Pregnant females.
  • Smokers.
  • Poor oral hygiene.
  • Vulnerable patients

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: Osseodensification with ridge splitting
Ridge splitting followed by osseodensification using osseodensifying burs .
Procedure: Ridge splitting followed by ossedensificaion
Ridge splitting followed by ossedensificaion with osseodensifying burs.
Procedure: Osseodensification
Pilot drill is used to make the initial osteotomy to the desired depth, then osseodensifying burs will be used in sequence, gradually wider diameter in a counterclockwise rotation and bouncing motion under profuse saline irrigation
Active Comparator: Osseodensification
osseodensification will be performed using osseodensifying burs.
Procedure: Osseodensification
Pilot drill is used to make the initial osteotomy to the desired depth, then osseodensifying burs will be used in sequence, gradually wider diameter in a counterclockwise rotation and bouncing motion under profuse saline irrigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessment of gain in alveolar ridge width
Time Frame: before surgery and immediately after surgery
Radiographically
before surgery and immediately after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
primary implant stability
Time Frame: at the end of surgery
Implant stability quotient measured by ostell
at the end of surgery
bone density
Time Frame: before surgery and immediately after surgery
radiographically
before surgery and immediately after surgery

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Study Director: Nevine H. El Din, Professor, Faculty of dentistry, Ain shams 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 (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

September 29, 2022

First Submitted That Met QC Criteria

October 4, 2022

First Posted (Actual)

October 6, 2022

Study Record Updates

Last Update Posted (Actual)

October 6, 2022

Last Update Submitted That Met QC Criteria

October 4, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FDASU-Rec ID032211

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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