Clinical trial NCT03888560: Duration Of Lower Labial Segment Alignment With Repeated Micro-Osteoperforations:
Official title: Duration Of Lower Labial Segment Alignment With Repeated Micro-Osteoperforations: Randomised Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion
Keywords: micro-osteperforation
orthodontic tooth movement
treatment duration
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2019-03-25
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The start date of lower labial segment alignment (T1) was recorded after insertion of the lower 0.014'' NiTi archwire. Participants were reviewed every 6 weeks and repeated MOPs were performed for the MOP group until the completion of lower labial segment alignment (LLS), which is when the LII scores one, indicating a minimum irregularity of ≤ 2 mm contact point displacement, based on the contact point displacements of the mandibular anterior segment, from canine to canine. At the end of alignment stage, the date for completion of alignment was recorded (T2), from which the overall alignment time (OAT) in days, required to complete LLS alignment, were calculated. Measurements were done clinically using an electric digital caliper. At this point, perforations were stopped. Gingival recession and black triangle were then recorded and measured. Patients were referred for CBCT images to evaluate for root resorption.
Primary purpose: TREATMENT

Brief summary: The main purpose is to compare overall alignment time (OAT) in days in alleviating mandibular incisors crowding between control group and MOPs group.Furthermore, to investigate the presence of volumetric root resorption from CBCT, gingival recession and formation of black triangle post lower labial segment alignment between micro-osteoperforations group and control group.

Detailed description: Prolonged treatment time in orthodontics is an undesirable side effect for both the patient and clinician. Usually, an average course of comprehensive orthodontic treatment with fixed appliances requires less than 2 years to complete (19.9 months). This prolonged treatment time may cause adverse effects such as root resorption, gingival recession, caries \& enamel demineralization. Micro-osteoperforations is safe, minimally invasive technique which perforations are performed through the gum tissues, penetrating the bone without the need to raise a ﬂap.Control group will not received any MOP and will receive standard orthodontic treatment.

Eligibility criteria: Inclusion Criteria:

* Gender : Male and Female
* Age range : ≥ 18years to 45 years old
* Crowding of 3mm - 7mm on lower labial segment (lower right canine to lower left canine) which does not require extractions in the lower arch
* Class II div I Incisor relationship with extraction of both upper 1st premolars
* Maximum anchorage control with temporary anchorage device ( TAD) , with Molar Class II (¼ to full unit) malocclusion
* Average vertical facial proportions
* No systemic disease
* Acceptable good oral hygiene
* No periodontal disease

Exclusion Criteria:

* Smokers
* Distally angulated canines
* History of trauma (crown fracture or avulsion and re-implantation) , endodontic treatment
* Missing permanent mandibular anterior teeth ( Hypodontia) / Retained deciduous teeth in mandibular anterior area
* Habits eg: fingernails biting , toothpick user , using hard toothbrush
* Vertical skeletal discrepancies eg high angle and low angle
* Systemic disease especially on long term use of antibiotics, phenytoin, cyclosporin, anti-inflammatory drugs, systemic corticosteroid and calcium channel blockers
* Poor oral hygiene for more than 3 visits
* Current periodontal disease

Primary outcomes:
measure: 1. To compare the duration to align the lower labial segment (33-43), between regular and irregular review groups from the conventional (control group).
timeFrame: 5 months
measure: 2. To compare the duration to align the lower labial segment (33-43), between regular and irregular review groups from the micro-osteoperforations group.
timeFrame: 5 months
measure: 3. To compare the duration to align the lower labial segment (33-43), between micro-osteoperforations and control group in the regular review group.
timeFrame: 5 months
measure: 4. To compare the duration to align the lower labial segment (33-43), between micro-osteoperforations and control group in the irregular review group.
timeFrame: 5 months
Secondary outcomes:
measure: Total volume of root resorption with micro-osteoperforations group vs the control group
timeFrame: 5 months
measure: Gingival recession between micro-osteoperforations and control group.
timeFrame: 5 months
measure: Black triangle between micro-osteoperforations and control group.
timeFrame: 5 months
Other outcomes:
Locations:
city: Kajang
country: Malaysia
facility: Faculty of Dentistry , University of Malaya
state: Kuala Lumpur
Study officials:
affiliation: University of Malaya
name: Nik Nuraini Nik Azmin
role: PRINCIPAL_INVESTIGATOR
affiliation: faculty of dentistry university of malaya
name: lorretha p ringgingon
role: PRINCIPAL_INVESTIGATOR
affiliation: faculty of dentistry university of malaya
name: Saritha Sivarajan
role: STUDY_DIRECTOR
affiliation: faculty of dentistry university of malaya
name: wey mang chek
role: STUDY_DIRECTOR
affiliation: faculty of dentistry university of malaya
name: mona fayed
role: STUDY_DIRECTOR
References:
citation: Teixeira CC, Khoo E, Tran J, Chartres I, Liu Y, Thant LM, Khabensky I, Gart LP, Cisneros G, Alikhani M. Cytokine expression and accelerated tooth movement. J Dent Res. 2010 Oct;89(10):1135-41. doi: 10.1177/0022034510373764. Epub 2010 Jul 16.
citation: Alikhani M, Raptis M, Zoldan B, Sangsuwon C, Lee YB, Alyami B, Corpodian C, Barrera LM, Alansari S, Khoo E, Teixeira C. Effect of micro-osteoperforations on the rate of tooth movement. Am J Orthod Dentofacial Orthop. 2013 Nov;144(5):639-48. doi: 10.1016/j.ajodo.2013.06.017.
citation: Alkebsi A, Al-Maaitah E, Al-Shorman H, Abu Alhaija E. Three-dimensional assessment of the effect of micro-osteoperforations on the rate of tooth movement during canine retraction in adults with Class II malocclusion: A randomized controlled clinical trial. Am J Orthod Dentofacial Orthop. 2018 Jun;153(6):771-785. doi: 10.1016/j.ajodo.2017.11.026.
citation: Sivarajan S, Doss JG, Papageorgiou SN, Cobourne MT, Wey MC. Mini-implant supported canine retraction with micro-osteoperforation: A split-mouth randomized clinical trial. Angle Orthod. 2019 Mar;89(2):183-189. doi: 10.2319/011518-47.1. Epub 2018 Oct 29.
citation: Attri S, Mittal R, Batra P, Sonar S, Sharma K, Raghavan S, Rai KS. Comparison of rate of tooth movement and pain perception during accelerated tooth movement associated with conventional fixed appliances with micro-osteoperforations - a randomised controlled trial. J Orthod. 2018 Dec;45(4):225-233. doi: 10.1080/14653125.2018.1528746. Epub 2018 Oct 3.