Ridge Splitting Using Autogenous Bone Wedge Versus the Conventional Intercortical Augmentation Technique in Horizontally Deficient Anterior Maxilla

July 26, 2024 updated by: Mohammed Abdel Salam Ibrahim Omara, Cairo University

Ridge Splitting Using Autogenous Bone Wedge Versus the Conventional Intercortical Augmentation Technique in Horizontally Deficient Anterior Maxilla A Randomized Clinical Trial

The current study aimed to evaluate both the quality and quantity of gained and maintained bone width after ridge splitting utilizing autogenic bone wedges versus mixed bone particles for horizontal ridge augmentation in the anterior esthetic zone.

Study Overview

Status

Recruiting

Intervention / Treatment

Detailed Description

This randomized clinical study included 20 patients with a horizontally deficient ridge in the esthetic region. Two groups were divided according to the type of intercortical bone graft used after ridge splitting: 10 patients for each. (The intervention group) had grafting with autogenous bone wedges harvested from the chin, and (the control group) had mixed (autogenic and xenogenic) bone particles.

Study Type

Interventional

Enrollment (Estimated)

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.

Study Contact

Study Contact Backup

  • Name: Mohamed Omara, PHD
  • Phone Number: 01144452862

Study Locations

      • Cairo, Egypt
        • Recruiting
        • oral and maxillo facial Surgery Department; Faculty of dentistry, Cairo University.
        • Contact:
          • yasmin ahmed, B.D.S
          • Phone Number: 01065273456

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:

  1. All patients possessed partially edentulous anterior maxillary ridge with the following criteria

    1. The anterior maxillary vertical dimension was more than ten mm measured from the alveolar crest to the basal bone of the maxilla.
    2. The horizontal alveolar dimension varies from 3-5 mm at the crest and 6-8 mm at the basal part of the ridge measured from the labial cortex to the lingual cortex.
  2. All patients were free from any medical conditions that may affect bone healing .
  3. No local pathosis that may interfere with bone healing.
  4. No previous grafting procedures at the indicated edentulous ridge.

    -

    Exclusion Criteria:

1- Patients suffering from any systemic disease that may affect bone healing. 2- Patients with less than 3mm labio palatal alveolar ridge width. 3- Ridge with inadequate vertical bone height. 4- Presence of any local pathosis that may interfere with bone healing. 5- Patients unable to continue the whole follow up.

-

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: intervention group
the group using an autogenous bone wedge harvested from the chin interpositioned between split cortices in the anterior maxilla to manage the horizontal deficiency of the ridge.
autogenous bone block harvested from chin and adjusted to be wedged intercortical in split ridge
Other: control group
the group used mixed autogenic and xenogenic bone particles that interposed between split cortices in anterior maxilla to manage the horizontal deficiency of the ridge
autogenous bone block harvested from chin and adjusted to be wedged intercortical in split ridge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone width in (mm) by cone beam pre, immediate post operative and 6 months postoperative
Time Frame: 6 months
after ridge augmentation in both groups, the bone width will be measured immediately postoperatively and 6 months postoperatively with cone beam and the measurements of the three intervals (pre-, immediate and 6 months postoperatively) will be compared in both groups to evaluate the amount of gained and maintained bone width
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage of areas of new bone (%)
Time Frame: 6 months
The harvested core biopsies would be stained with H&E and Massons trichrome stain and be microscopically examined to determine percentage areas of newly formed bone
6 months

Collaborators and Investigators

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

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.

Helpful Links

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)

October 30, 2022

Primary Completion (Estimated)

August 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

July 24, 2024

First Submitted That Met QC Criteria

July 26, 2024

First Posted (Actual)

July 31, 2024

Study Record Updates

Last Update Posted (Actual)

July 31, 2024

Last Update Submitted That Met QC Criteria

July 26, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

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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