Clinical trial NCT06313229: Simultaneous Implant Placement With Vertical and Horizontal Bone Augmentation
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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alveolar Bone Loss
Dental Implant Failed
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-center, prospective, single-blinded, randomized parallel two-arm controlled clinical trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Stability Quotient of Implants (SQI)
timeFrame: 12-month.
measure: Horizontal bone dimensions (HBDs)
timeFrame: 12-month.
measure: Peri-implant Bone Density (PBD)
timeFrame: 12-month.
Secondary outcomes:
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: faculty of dentistry, kafrelsheikh University
state: Kafrelsheikh
Study officials:
affiliation: Faculty of Oral and Dental Medicine, Kafrelsheikh University
name: Walid AH Elamrousy, PhD
role: PRINCIPAL_INVESTIGATOR
References: