Full Thickness Mucoperiosteal Flap Versus Low Level Laser in Orthodontic Tooth Movement Acceleration

Evaluation of the Effect of Full Thickness Mucoperiosteal Flap Versus Low Level Laser in Orthodontic Tooth Movement Acceleration

This study aimed to evaluate the effect of using full thickness mucoperiosteal flap (FTMPF) elevation only versus low level laser therapy (LLLT) on acceleration of orthodontic tooth movement.

Study Overview

• Status: Completed
• Conditions: Mesial Movement of Teeth
• Intervention / Treatment: Procedure: elevation of full thickness mucoperiosteal flap; Device: low level laser therapy

Detailed Description

This study was a split mouth design study included 32 side according to sample size calculation. Those sides were divided into 2 groups. Group 1divided into (group 1a: 8 sides with FTMPF, group 1b:8 sides control). Group 2(group 2 a: 8 sides with LLLT, group 2b: 8 sides control). Extraction of the first maxillary premolars followed by canine retraction in the extraction space with maximum anchorage were indicated. FTMPF was elevated from the mesial interdental papilla of maxillary canine to the mesial interdental papilla of second maxillary premolar. LLLT was applied at 3,7,14,28.56 days of retraction. During retraction study model for all patients were taken at 2ed, 6th, 14th,16th weeks and at the end of retraction (I1,I2,I3,I4,I5 or overall interval). 3D laser scanning and digital superimposition was done to measure the rate of canine retraction and anchorage loss.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Naser City
    • Cairo, Naser City, Egypt, 7118
      • Faculty of dentistry ,Al-Azhar Univerisity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• o Free of any syndromes affecting the head region or any craniofacial injuries.

  • No history of previous orthodontic treatment
  • All of the permanent dentition present excluding third molars.
  • Good oral hygiene before starting treatment.
  • Cases indicated for extraction of the maxillary first premolars and canine retraction into the extraction space with maximum anchorage.
  • Malocclusion cases that allow initial stage of leveling and alignment without extraction.

Exclusion Criteria:

• o Patients with systemic diseases especially bleeding disorders and osteoporosis.

  • History of administration of corticosteroids, exogenous hormones and non-steroidal anti-inflammatory drugs (all drugs interfere with OTM).
  • Presence of previous history of oral surgeries in maxillary arch.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: full thickness mucoperiosteal flap; A full thickness mucoperiosteal flap (FTMPF) was reflected on FTMPF side at the maxillary canine/premolar region by the same surgeon for all patients following the same procedures.	Procedure: elevation of full thickness mucoperiosteal flap; A free gingival sulcular incision was done from the distal surface of maxillary second premolar to the mesial side of the maxillary canine. A releasing oblique incision was done including the interdental papilla between maxillary canine and lateral incisor extending to the mucogingival junction just beyond the attached mucosa. The flap reflection extended beyond the canine root apex. A FTMPF reflection was done with mucoperiosteal elevator. Free sulcus incision was done to allow elevation of palatal mucosa by tunneling technique on the palatal gingiva of maxillary canine.
Experimental: low level laser therapy; LLLT was done using a diode soft laser (Epic X, BioLase, USA). It is a semiconductor diode soft laser. Active medium is In-Ga-As with 940nm wave length	Device: low level laser therapy; LLLT was done using a diode soft laser (Epic X, BioLase, USA). It is a semiconductor diode soft laser. Active medium is In-Ga-As with 940nm wave length. LLLT protocol was using active laser tip (bleaching tip)
No Intervention: Control for Full thickness mucoperiosteal flap; Control for Full thickness mucoperiosteal flap, in which canine retraction was done in a conventional method
No Intervention: control for Low level laser therapy group; Control for Low level laser therapy , in which canine retraction was done in a conventional method

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of orthodontic tooth movement acceleration determination by measuring the rate of maxillary canine retraction	measure the rate of canine retraction on series of study models	the rate of retraction( distance from the first day of retraction to the end of retraction/ time)) it was with total time frame 24 weeks for starting of retraction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical mesial movement of first maxillary molar measured by millimeter on the 3D model	amount of mesial movement of first maxillary molar after 24 month	t0(start of canine retraction) to 24 months

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Principal Investigator: Mohsena a arazik, orthodontist, Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: July 30, 2019
• First Submitted That Met QC Criteria: August 12, 2019
• First Posted (Actual): August 14, 2019

Study Record Updates

• Last Update Posted (Actual): August 20, 2019
• Last Update Submitted That Met QC Criteria: August 18, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Migration; Mesial Movement of Teeth
• Other Study ID Numbers: Doctor's degree research

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: the data will be shared the weekly rate and distance of canine retraction, the amount of maxillary canine mesial movement and the periodontal pocket depth around the maxillary canine
• IPD Sharing Time Frame: by today,()30July 2019
• IPD Sharing Access Criteria: Google drive
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No