Accuracy of Guided Ridge Splitting With Simultaneous Implant Placement

March 21, 2024 updated by: Alexandria University

Accuracy of Novel Ridge Splitting Guide Design in Comparison to Freehand With Simultaneous Implant Placement

Assessing whether is there a difference between computer-guided ridge splitting and conventional technique with simultaneous implant placement in patients with maxillary width deficiency.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Two groups one treated with ridge splitting using guided surgery and the other one treated with freehand surgery and both groups had simultaneous dental implants the first one had guided placement and the other one was freehand.

Study Type

Interventional

Enrollment (Actual)

12

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 Locations

  • Egypt
      • Alexandria, Egypt, 21619
        • Alexandria University, Faculty of dentistry

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patient with missing maxillary anteriors or premolars teeth.
  • Tooth extraction at the implant sites was performed at least 4 months before the surgery.
  • The bone width of the crestal one -third (3-5 mm) with sufficient bone height allowing for simultaneous implant placement.
  • Free from any systemic disease or local pathological lesions that may affect bone healing or contraindicate implant placement.
  • With no history of any previous grafting surgeries at the area of interest.

Exclusion Criteria:

  • Sever concavity of the alveolar ridge.
  • Bad oral hygiene ( Silness-Löe index (score 2-3).
  • Heavy smoker (smoke greater than or equal 25 cigarettes per day).
  • Presence of acute infections or periapical lesions in adjacent teeth.
  • Parafunctional habits.
  • Pregnant females.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: study group treated with guided ridge splitting.
virtual surgical planning using planning software Blue Sky Bio (BSB) and 3D printed surgical guide are fabricated to guide the ridge splitting procedure and implant drilling and placement.
Procedure: dental implant placement with ridge splitting.
ridge splitting to increase bone width in atrophic maxilla with simultaneous implant placement
Active Comparator: control group treated with conventional ridge splitting.
Freehand surgery is done including ridge splitting and implant plaement
Procedure: dental implant placement with ridge splitting.
ridge splitting to increase bone width in atrophic maxilla with simultaneous implant placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing the accuracy of guided surgery
Time Frame: one week
superimposition of post-op cbct to the planned position to check the accuracy of implant positions.
one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the bone-width increase between control and study group.
Time Frame: 6 months
evaluation of two techniques of ridge splitting in increasing bone width.
6 months

Collaborators and Investigators

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

Sponsor

Alexandria University

Investigators

  • Principal Investigator: Mahmoud Elbayaa, Alexandria 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)

August 2, 2023

Primary Completion (Actual)

January 29, 2024

Study Completion (Actual)

February 27, 2024

Study Registration Dates

First Submitted

March 21, 2024

First Submitted That Met QC Criteria

March 21, 2024

First Posted (Actual)

March 27, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ridgesplittingguided

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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