Clinical trial NCT04055935: Full Thickness Mucoperiosteal Flap Versus Low Level Laser in Orthodontic Tooth Movement Acceleration
Official title: Evaluation of the Effect of Full Thickness Mucoperiosteal Flap Versus Low Level Laser in Orthodontic Tooth Movement Acceleration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mesial Movement of Teeth
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2019-08-14
Enrollment: 32
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: split mouth study design, side intervention and other side for control
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: rate of orthodontic tooth movement acceleration determination by measuring the rate of maxillary canine retraction
timeFrame: 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:
measure: clinical mesial movement of first maxillary molar measured by millimeter on the 3D model
timeFrame: t0(start of canine retraction) to 24 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry ,Al-Azhar Univerisity
state: Naser City
Study officials:
affiliation: Al-Azhar University
name: Mohsena a arazik, orthodontist
role: PRINCIPAL_INVESTIGATOR
References: