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

NCT04055935 | Completed

• 1 other identifier: Doctor's degree research
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mesial Movement of Teeth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• clinical mesial movement of first maxillary molar measured by millimeter on the 3D model

  t0(start of canine retraction) to 24 months

Study Arms (4)

full thickness mucoperiosteal flap

EXPERIMENTAL

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

low level laser therapy

EXPERIMENTAL

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

Control for Full thickness mucoperiosteal flap

NO INTERVENTION

Control for Full thickness mucoperiosteal flap, in which canine retraction was done in a conventional method

control for Low level laser therapy group

NO INTERVENTION

Control for Low level laser therapy , in which canine retraction was done in a conventional method

Interventions

elevation of full thickness mucoperiosteal flap PROCEDURE

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.

full thickness mucoperiosteal flap

low level laser therapy DEVICE

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)

low level laser therapy

Eligibility Criteria

• Age: 15 Years - 20 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Faculty of dentistry ,Al-Azhar Univerisity

Cairo, Naser City, 7118, Egypt

Location

MeSH Terms

Conditions

Mesial Movement of Teeth

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Tooth Migration; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Mohsena a arazik, orthodontist

  Al-Azhar University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of orthodontics

Model Details: split mouth study design, side intervention and other side for control

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: August 14, 2019
• Study Start: September 1, 2017
• Primary Completion: April 1, 2019
• Study Completion: June 1, 2019
• Last Updated: August 20, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: by today,()30July 2019
• Access Criteria: Google drive

Locations

EG (1)