Effect of Low-level Laser Therapy During Maxillary Molar Distalization Using a Skeletally Anchored Appliance

Effect of Low-level Laser Therapy During Maxillary Molar Distalization Using a Skeletally Anchored Appliance: A Prospective Clinical Study

study will be directed to evaluate the effect of low-level laser therapy during maxillary molar distalization using a skeletally anchored appliance

Study Overview

• Status: Recruiting
• Conditions: Class II Division 1 Malocclusion
• Intervention / Treatment: Other: Distalization

Detailed Description

Effect of low-level laser therapy during maxillary molar distalization using a skeletally anchored appliance

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed T Hussein, doctoraa; Phone Number: 01008748904; Email: AhmedAli.209@azhar.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Al Azhar University
    • Contact: Ahmed T Ali, Ass. lecturer; Phone Number: +20 01008748904; Email: ahmedAli.209@azhar.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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:

1. Patients who required surgery to correct skeletal discrepancies.
2. Patients with congenital dentoskeletal disorders.
3. Missed or mutilated teeth in maxillary arch.
4. Patients with poor oral hygiene and/or periodontally compromised patients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I; will include 10 patients undergo distalization according to a standardized protocol	Other: Distalization; 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.
Active Comparator: Group II; will include 10 patients undergo distalization assisted with low level laser therapy according to a standardized protocol	Other: Distalization; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	from start of treatment until study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2021
• Primary Completion (Anticipated): August 12, 2022
• Study Completion (Anticipated): December 12, 2022

Study Registration Dates

• First Submitted: July 8, 2022
• First Submitted That Met QC Criteria: July 17, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 17, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: 647/1760

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No