Simultaneous Implant Placement With Vertical and Horizontal Bone Augmentation

NCT06313229 | Active Not Recruiting DMC

• 1 other identifier: KFSIRB200-195
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Alveolar Bone Loss; Dental Implant Failed

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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.

Study Arms (2)

Staged implant placement approach

EXPERIMENTAL

the bone defect was grafted using bone plates buccally and palatally and the defect between plates was grafted by sticky allogenic bone graft. 6 months later the implant was placed in the grafted site.

Procedure: implant placement 6 months after ridge augmentation

Simultaneous implant placement approach

EXPERIMENTAL

the bone defect was grafted using bone plates buccally and palatally and the defect between plates was grafted by sticky allogenic bone graft combined with simultaneous implant placement.

Procedure: implant placement Simultaneously with ridge augmentation

Interventions

implant placement 6 months after ridge augmentation PROCEDURE

the deficient ridge was grafted first followed by implant placement after 6-monthes

Staged implant placement approach

implant placement Simultaneously with ridge augmentation PROCEDURE

the deficient ridge was grafted and followed by implant placement simultaneously

Simultaneous implant placement approach

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

faculty of dentistry, kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 214312, Egypt

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Walid AH Elamrousy, PhD

  Faculty of Oral and Dental Medicine, Kafrelsheikh University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The present clinical trial was single-blinded one as the evaluator and the statistician were both blinded. While both the implantologist or the participant were not blinded as the interventions were dissimilar.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of periodontology

Model Details: single-center, prospective, single-blinded, randomized parallel two-arm controlled clinical trial

Study Record Dates

• First Submitted: March 9, 2024
• First Posted: March 15, 2024
• Study Start: April 15, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 18, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

EG (1)