NCT06887595

Brief Summary

The traditional ridge split technique might be performed simultaneously with implant placement, resulting in a shortened treatment time. However, this approach has the potential for serious complications, including buccal bone fracture, prolonged pain or paresthesia, and loss of bone height. Linear Micro-Perforation Osteotomy (LMPO) has emerged as a less invasive alternative, promoting natural bone expansion through controlled micro-perforations in the cortical bone, allowing for ridge widening without extensive grafting. However, the precision required for LMPO can be difficult to achieve manually, especially in anatomically complex or narrow ridge areas, leading to variability in outcomes and potential risks such as bone fractures or inadequate expansion.Our study aims to evaluate the efficacy, clinical, and radiological outcomes of the flapless AI-powered/computer-guided LMPO ridge split/expansion technique compared to the traditional LMPO ridge split/expansion method for lateral ridge reconstruction of mandibular horizontal ridge deficiencies.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

March 18, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 20, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2026

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

March 16, 2025

Last Update Submit

November 20, 2025

Conditions

Alveolar Bone LossDental Implant Failed

Outcome Measures

Primary Outcomes (1)

  • ridge width

    The width of the alveolar bone will be measured again using CBCT

    12-months

Study Arms (2)

study group I

EXPERIMENTAL

ridge split and expansion with free-hand linear micro perforation osteotomy approach with simultaneous implant placement

Procedure: Free-hand linear micro perforation osteotomy and ridge splitting

study group II

EXPERIMENTAL

ridge split and expansion with AI-assisted/computer-guided (linear micro perforation osteotomy approach with simultaneous implant placement)

Procedure: AI-assisted/computer-guided linear micro perforation osteotomy and ridge splitting

Interventions

Free-hand linear micro perforation osteotomy and ridge splittingPROCEDURE

AI-assisted/computer-guided linear micro perforation osteotomy and ridge splitting

Also known as: Free-hand crestal ridge splitting expansion after linear micro perforation osteotomy will be performed using electromagnetic mallet
study group I
AI-assisted/computer-guided linear micro perforation osteotomy and ridge splittingPROCEDURE

AI-assisted/computer-guided crestal ridge splitting expansion after linear micro perforation osteotomy will be performed using electromagnetic mallet

study group II

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients presenting with narrow alveolar ridge that requires dental implantation.
  • Minimum bone width of 3 mm
  • Ridge width of not less than 3 mm in CBCT image
  • Minimum bone height of 10 mm
  • Proper inter-occlusal space
  • Perioperative cone beam CT scan image of the atrophic ridge

You may not qualify if:

  • Uncontrolled diabetes.
  • Heavy smokers.
  • Current chemotherapy or radiotherapy.
  • Alcohol or drug abuse.
  • Pregnant women.
  • Active infection.
  • Inter-occlusal space not less than 7-8 mm.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of periodontology

Study Record Dates

First Submitted

March 16, 2025

First Posted

March 20, 2025

Study Start

March 18, 2025

Primary Completion

March 20, 2026

Study Completion

March 30, 2026

Last Updated

November 25, 2025

Record last verified: 2025-11

Locations

EG(1)