Comparison of Piezoelectric Split-crest Technique Versus Expansion Using Hand Driven Ridge Expanders in Treatment of Maxillary Narrow Ridges
Primary Purpose
Edentulous Alveolar Ridge
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
piezoelectric
Sponsored by
About this trial
This is an interventional treatment trial for Edentulous Alveolar Ridge
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients with residual infections in the edentulous areas.
- Medically compromised groups.
- Smokers and patients with poor oral hygiene.
Sites / Locations
- Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Piezoelectric split-crest technique in treatment of Maxillary Narrow Ridges
Hand Driven Ridge Expanders in treatment of Maxillary Narrow Ridges
Arm Description
Piezoelectric split-crest technique in treatment of Maxillary Narrow Ridges
Hand Driven Ridge Expanders in treatment of Maxillary Narrow Ridges
Outcomes
Primary Outcome Measures
bone width
bone width gain in millimeters
Secondary Outcome Measures
implant stability
implant stability measured with periotest
Full Information
NCT ID
NCT05141331
First Posted
November 19, 2021
Last Updated
December 2, 2021
Sponsor
ahmed ashraf abdelreheem
1. Study Identification
Unique Protocol Identification Number
NCT05141331
Brief Title
Comparison of Piezoelectric Split-crest Technique Versus Expansion Using Hand Driven Ridge Expanders in Treatment of Maxillary Narrow Ridges
Official Title
Comparison of Piezoelectric Split-crest Technique Versus Expansion Using Hand Driven Ridge Expanders in Treatment of Maxillary Narrow Ridges
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2021 (Actual)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
ahmed ashraf abdelreheem
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Comparison of Piezoelectric split-crest technique versus expansion using Hand Driven Ridge Expanders in treatment of Maxillary Narrow Ridges
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Alveolar Ridge
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Piezoelectric split-crest technique in treatment of Maxillary Narrow Ridges
Arm Type
Experimental
Arm Description
Piezoelectric split-crest technique in treatment of Maxillary Narrow Ridges
Arm Title
Hand Driven Ridge Expanders in treatment of Maxillary Narrow Ridges
Arm Type
Active Comparator
Arm Description
Hand Driven Ridge Expanders in treatment of Maxillary Narrow Ridges
Intervention Type
Device
Intervention Name(s)
piezoelectric
Intervention Description
Comparing Piezoelectric split-crest technique versus expansion using Hand Driven Ridge Expanders in treatment of Maxillary Narrow Ridges
Primary Outcome Measure Information:
Title
bone width
Description
bone width gain in millimeters
Time Frame
5 months
Secondary Outcome Measure Information:
Title
implant stability
Description
implant stability measured with periotest
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Patients with residual infections in the edentulous areas.
Medically compromised groups.
Smokers and patients with poor oral hygiene.
Facility Information:
Facility Name
Cairo University
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ahmed ashraf
Phone
01100087668
Email
dr.aashraf9@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Comparison of Piezoelectric Split-crest Technique Versus Expansion Using Hand Driven Ridge Expanders in Treatment of Maxillary Narrow Ridges
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