Back to resultsEffect of Low-level Laser Therapy During Maxillary Molar Distalization Using a Skeletally Anchored Appliance
Primary Purpose
Class II Division 1 Malocclusion
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Distalization
Sponsored by
About this trial
This is an interventional treatment trial for Class II Division 1 Malocclusion
Eligibility Criteria
Inclusion Criteria:
- 1- An age range from 14-17 years old. 2- All permanent teeth are present (except for third molars). 3- Bilateral dental Class II malocclusion. 4- Skeletal Class I or mild Class II relationship. 5- Normal or reduced vertical face height. 6- No posterior crowding or spaces.
Exclusion Criteria:
- Patients who required surgery to correct skeletal discrepancies.
- Patients with congenital dentoskeletal disorders.
- Missed or mutilated teeth in maxillary arch.
- Patients with poor oral hygiene and/or periodontally compromised patients.
Sites / Locations
- Al Azhar universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group I
Group II
Arm Description
will include 10 patients undergo distalization according to a standardized protocol
will include 10 patients undergo distalization assisted with low level laser therapy according to a standardized protocol
Outcomes
Primary Outcome Measures
rate of molar distalization
rate of distalization of the maxillary first molars will be evaluated using direct clinical assessment and cast analysis according to standardized methods.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05465473
Brief Title
Effect of Low-level Laser Therapy During Maxillary Molar Distalization Using a Skeletally Anchored Appliance
Official Title
Effect of Low-level Laser Therapy During Maxillary Molar Distalization Using a Skeletally Anchored Appliance: A Prospective Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 12, 2021 (Actual)
Primary Completion Date
August 12, 2022 (Anticipated)
Study Completion Date
December 12, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
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
study will be directed to evaluate the effect of low-level laser therapy during maxillary molar distalization using a skeletally anchored appliance
Detailed Description
Effect of low-level laser therapy during maxillary molar distalization using a skeletally anchored appliance
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Division 1 Malocclusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group I
Arm Type
Active Comparator
Arm Description
will include 10 patients undergo distalization according to a standardized protocol
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
will include 10 patients undergo distalization assisted with low level laser therapy according to a standardized protocol
Intervention Type
Other
Intervention Name(s)
Distalization
Intervention Description
Group I: will include 10 patients undergo distalization according to a standardized protocol. Group II: will include 10 patients undergo distalization assisted with low level laser therapy according to a standardized protocol.
Primary Outcome Measure Information:
Title
rate of molar distalization
Description
rate of distalization of the maxillary first molars will be evaluated using direct clinical assessment and cast analysis according to standardized methods.
Time Frame
from start of treatment until study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
1- An age range from 14-17 years old. 2- All permanent teeth are present (except for third molars). 3- Bilateral dental Class II malocclusion. 4- Skeletal Class I or mild Class II relationship. 5- Normal or reduced vertical face height. 6- No posterior crowding or spaces.
Exclusion Criteria:
Patients who required surgery to correct skeletal discrepancies.
Patients with congenital dentoskeletal disorders.
Missed or mutilated teeth in maxillary arch.
Patients with poor oral hygiene and/or periodontally compromised patients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed T Hussein, doctoraa
Phone
01008748904
Email
AhmedAli.209@azhar.edu.eg
Facility Information:
Facility Name
Al Azhar university
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed T Ali, Ass. lecturer
Phone
01008748904
Ext
+20
Email
ahmedAli.209@azhar.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Low-level Laser Therapy During Maxillary Molar Distalization Using a Skeletally Anchored Appliance
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