NCT06274476

Brief Summary

evaluates the success of prosthetic rehabilitation of thin wiry ridge and implants placed simultaneously in splitted ridge both clinically and radiographically.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 9, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2019

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

1.2 years

First QC Date

February 15, 2024

Last Update Submit

February 21, 2024

Conditions

Atrophic Maxillary Ridge and Mandibular Ridge

Keywords

implantknife-edge ridgeridge expansionpiezoelectricimplant-supported prosthesisprosthetic complications

Outcome Measures

Primary Outcomes (1)

  • implant success

    implant osseointgeration by radiographic evaluation .bone loss by mm, and bone density

    12 month

Study Arms (2)

maxillary atrophic ridge

EXPERIMENTAL

received ridge splitting done by piezo surgery and implant placement in maxillary arch

Other: implant placement

mandibular atrophic ridge

ACTIVE COMPARATOR

received ridge splitting done by saw technique using ridge expanders and implant placement in maxillary arch

Other: implant placement

Interventions

implant placementOTHER

ridge splitting piezo surgery and implant placement

Also known as: implant installation
mandibular atrophic ridgemaxillary atrophic ridge

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ridge of 2 to 4 mm of initial alveolar crest width
  • bone height of at least 8 mm from vitastructures
  • good oral hygiene.

You may not qualify if:

  • patients who smoke more than 10 cigarettes per day diabetes mellitus, osteoporosis, and periodontal disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed yahia Sharaf

Zagazig, Sharqia Province, 44715, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
double
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: maxillary and mandibular atrophic ridge
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

February 15, 2024

First Posted

February 23, 2024

Study Start

September 9, 2018

Primary Completion

December 9, 2019

Study Completion

January 1, 2020

Last Updated

February 23, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)