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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
ahmed ashraf abdelreheem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edentulous Alveolar Ridge

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
November 19, 2021
Last Updated
December 2, 2021
Sponsor
ahmed ashraf abdelreheem
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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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