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Completed

NCT Number: NCT04055935

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.

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Key information

Conditions

Mesial Movement of Teeth Mouth Diseases Periodontal Diseases Stomatognathic Diseases Tooth Migration

Age range

15 year–20 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of dentistry ,Al-Azhar Univerisity

Cairo, Naser City, 7118, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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)

Primary outcomes

  1. rate of orthodontic tooth movement acceleration determination by measuring the rate of maxillary canine retraction

    Time frame: 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

    measure the rate of canine retraction on series of study models

Secondary outcomes

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

    Time frame: t0(start of canine retraction) to 24 months

    amount of mesial movement of first maxillary molar after 24 month

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 14, 2019
Registry last updated
Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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