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Clinical Trials/NCT06313229
NCT06313229
Active, Not Recruiting
N/A

Simultaneous Versus Staged Implant Placement With Vertical and Horizontal Bone Augmentation Using Autogenous Cortical Bone Plates Combined With a Mixture of Platelet-rich Fibrin and Allobone Grafts.

Kafrelsheikh University1 site in 1 country42 target enrollmentApril 15, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Alveolar Bone Loss
Sponsor
Kafrelsheikh University
Enrollment
42
Locations
1
Primary Endpoint
Stability Quotient of Implants (SQI)
Status
Active, Not Recruiting
Last Updated
5 months ago

Overview

Brief Summary

The purpose of this study was to report the clinical and radiographical outcomes of using autogenous cortical bone plates combined with sticky allogenic bone graft for augmenting maxillary anterior atrophic combined horizontal and vertical ridge defects with simultaneous versus staged implant placement.

Detailed Description

Sufficient alveolar ridge is a prerequisite for successful implant stability, atrophic ridges defects make the placement of regular implants challenging. A variety of materials and surgical techniques are available for bone augmentation procedures prior implant placement. The present study evaluated the effect of sticky allogenic bone graft for the horizontal and vertical ridge augmentation with simultaneous implant placement using autogenous cortical bone plates in maxillary anterior atrophic ridge defects. Forty-two patients, with severe maxillary anterior horizontal and vertical atrophic ridge deficiencies were randomly assigned to two groups: staged approach group and simultaneous implant placement group. The two groups were grafted using bone plated buccally and palatally and the defect between plates was grafted by sticky allogenic bone graft. Radiographic examination was performed immediately before bone grafting procedure and at 6, 12 months postoperatively, to evaluate the change of bone width and height.

Registry
clinicaltrials.gov
Start Date
April 15, 2024
End Date
May 18, 2026
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Walid Elamrousy

Assistant Professor of periodontology

Kafrelsheikh University

Eligibility Criteria

Inclusion Criteria

  • Good general health at the time of surgery
  • At least 3 months of healing after tooth extraction
  • Horizontally and vertical compromised alveolar ridges

Exclusion Criteria

  • Thick cortex in the labial/buccal with less cancellous bone inside;
  • Obvious undercut on the labial/buccal side
  • Uncontrolled periodontal conditions or other oral disorders;
  • history of radiotherapy in the head and neck region

Outcomes

Primary Outcomes

Stability Quotient of Implants (SQI)

Time Frame: 12-month.

The implant stability was recorded using Osstell TM. Following implant insertion, SQI readings were taken immediately, then again after six and twelve months.

Horizontal bone dimensions (HBDs)

Time Frame: 12-month.

The HBD alterations were assessed by measuring horizontal spacing between the external edges of labial and palatal bony plates at a level 2mm apical of the fixture platform.

Peri-implant Bone Density (PBD)

Time Frame: 12-month.

For consistent measurement of the PBD, 1-mm-diameter Region of interest (RI) was selected and traced 1.2 mm distant from the fixture on the cross-sectional slices followed by counting the threshold pixels inside the RI.

Study Sites (1)

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