NCT05141331

Brief Summary

Comparison of Piezoelectric split-crest technique versus expansion using Hand Driven Ridge Expanders in treatment of Maxillary Narrow Ridges

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

May 20, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 2, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

December 3, 2021

Status Verified

December 1, 2021

Enrollment Period

12 months

First QC Date

November 19, 2021

Last Update Submit

December 2, 2021

Conditions

Edentulous Alveolar Ridge

Outcome Measures

Primary Outcomes (1)

  • bone width

    bone width gain in millimeters

    5 months

Secondary Outcomes (1)

  • implant stability

    5 months

Study Arms (2)

Piezoelectric split-crest technique in treatment of Maxillary Narrow Ridges

EXPERIMENTAL

Piezoelectric split-crest technique in treatment of Maxillary Narrow Ridges

Device: piezoelectric

Hand Driven Ridge Expanders in treatment of Maxillary Narrow Ridges

ACTIVE COMPARATOR

Hand Driven Ridge Expanders in treatment of Maxillary Narrow Ridges

Device: piezoelectric

Interventions

piezoelectricDEVICE

Comparing Piezoelectric split-crest technique versus expansion using Hand Driven Ridge Expanders in treatment of Maxillary Narrow Ridges

Hand Driven Ridge Expanders in treatment of Maxillary Narrow RidgesPiezoelectric split-crest technique in treatment of Maxillary Narrow Ridges

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants are free from any systemic diseases.
  • Participant have missing one or two premolars or molars with sufficient alveolar ridge height and insufficient alveolar ridge buccolingual (BL) width that interfere with conventional straight forward implant placement.
  • The minimum BL ridge width included in the study will be 3.5 mm to facilitate ridge splitting and expansion

You may not qualify if:

  • Patients with residual infections in the edentulous areas.
  • Medically compromised groups.
  • Smokers and patients with poor oral hygiene.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, Egypt

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

November 19, 2021

First Posted

December 2, 2021

Study Start

May 20, 2021

Primary Completion

May 1, 2022

Study Completion

July 1, 2022

Last Updated

December 3, 2021

Record last verified: 2021-12

Locations

EG(1)