Clinical trial NCT05183451: Effect Of Low Level Laser Therapy on the Rate of En- Masse Retraction: RCT
Official title: Effect of Low-level Laser Therapy on the Rate of En-masse Retraction in Adult Females With Bimaxillary Dentoalveolar Protrusion: a Single-center Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bimaxillary Protrusion
Keywords: En-masse retraction
Rate of tooth movement
Low Level Laser Therapy (LLLT)
3D
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-01-10
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is scarcity in the literature regrading the effect of Low Level Laser Therapy (LLLT) on the rate of en-masse retraction. This study aims to investigate whether LLLT would affect the rate of en-masse retraction in females having bimaxillary dento-alveolar protrusion.

Detailed description: Individuals having bimaxillary dentoalveolar protrusion are characterized by proclined upper and lower incisors and increased procumbency of the lips thus suffering from poor facial esthetics. The conventional management of these patients is the extraction of the first premolars and retraction of the anterior teeth.

One of the treatment techniques is in the form of canine retraction followed by four incisors retraction. This conventional method takes tedious work and tremendous time, thus affecting the patients' satisfaction adversely. The other technique is retraction of the whole set of anterior teeth as one unit (Canine and incisors), which is referred to as "En-Masse retraction".

Enhancing the rate of orthodontic tooth movement has always been a supreme goal of orthodontic research hoping to raise the level of care delivered to patients, hence, increase patients' satisfaction.

One of the proposed modalities of increasing the rate of tooth movement is Low Level Laser Therapy (LLLT). Thus, the aim of the current consideration was to evaluate the impact of LLLT on the rate of en-masse retraction in adult females having bimaxillary dentoalveolar protrusion.

Eligibility criteria: Inclusion Criteria:

* Adult females
* Patients having bimaxillary dento- alveolar protrusion and Class I Molar relation
* Cases requiring maximum anchorage during retraction.
* Good general and oral health

Exclusion Criteria:

* Patients suffering from any systemic diseases interfering with tooth movement.
* Patients with extracted or missing permanent teeth. (except for third molars).
* Patients with badly decayed teeth (Other than 1st premolars).
* Patients with any parafunctional habits (i.e. Bruxism, tongue thrusting, mouth breathing, etc...).
* Patients with previous orthodontic treatment
* Pregnant females

Primary outcomes:
measure: Rate of en-masse retraction
timeFrame: From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year
Secondary outcomes:
measure: Anterior teeth's root resorption
timeFrame: From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year
measure: Anterior teeth Tip and Torque
timeFrame: From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year
measure: Anchorage (Loss/ Gain)
timeFrame: From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year
measure: First molars' rotation
timeFrame: From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year
measure: Pain Associated
timeFrame: From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Heba Mohamed E Dehis, Lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Foad A El-Sharaby, A. Professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Faten H Eid, Professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Mushira Dahaba, Professor
role: STUDY_DIRECTOR
affiliation: Future University in Egypt (FUE)
name: Yehya A Mostafa, Professor
role: STUDY_DIRECTOR
References: