Simultaneous Implant Placement With Vertical and Horizontal Bone Augmentation

Alveolar Bone Loss Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06313229
• Other study ID #: KFSIRB200-195
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: Kafrelsheikh University
• Contact: Walid AH Elamrousy, PhD
• Phone: +201091444946
• Email: perioking1[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: March 31, 2025
• Est. primary completion date: March 25, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Dental Implant Failed

Intervention

Procedure:
• implant placement 6 months after ridge augmentation
the deficient ridge was grafted first followed by implant placement after 6-monthes
• implant placement Simultaneously with ridge augmentation
the deficient ridge was grafted and followed by implant placement simultaneously

Locations

Country	Name	City	State
Egypt	faculty of dentistry, kafrelsheikh University	Kafr Ash Shaykh	Kafrelsheikh

Sponsors (1)

Lead Sponsor	Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stability Quotient of Implants (SQI)	The implant stability was recorded using Osstell TM. Following implant insertion, SQI readings were taken immediately, then again after six and twelve months.	12-month.
Primary	Horizontal bone dimensions (HBDs)	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.	12-month.
Primary	Peri-implant Bone Density (PBD)	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.	12-month.