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

NCT ID: NCT04055935

Last Updated: 2019-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2019-06-01

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.

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.

Conditions

Mesial Movement of Teeth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

elevation of full thickness mucoperiosteal flap

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

low level laser therapy

Intervention Type: 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)

Control for Full thickness mucoperiosteal flap

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

control for Low level laser therapy group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

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)

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Mohsena Ahmad

Assistant lecturer of orthodontics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohsena a arazik, orthodontist

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar University

Locations

Faculty of dentistry ,Al-Azhar Univerisity

Cairo, Naser City, Egypt

Countries

Egypt

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

Doctor's degree research

Identifier Type: -

Identifier Source: org_study_id