Duration Of Lower Labial Segment Alignment With Repeated Micro-Osteoperforations:

Malocclusion Clinical Trial

— MOP  

Official title:

Duration Of Lower Labial Segment Alignment With Repeated Micro-Osteoperforations: Randomised Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03888560
• Other study ID #: DGD170005
• Status: Completed
• Phase: N/A
• Start date: November 19, 2018
• Est. completion date: April 14, 2021

Study information

• Verified date: October 2021
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 14, 2021
• Est. primary completion date: April 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Malocclusion

Intervention

Device:
• Micro-osteoperforations
MOPs will be performed using SIA Excalibur Mini-Implant with dimension 1.6 mm in width and length of 6 mm, screw 3 mm depth into buccal bone of intervention sites

Locations

Country	Name	City	State
Malaysia	Faculty of Dentistry , University of Malaya	Kajang	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. To compare the duration to align the lower labial segment (33-43), between regular and irregular review groups from the conventional (control group).	Total treatment time needed to achieved lower labial segment alignment until Little's irregularity index 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	5 months
Primary	2. To compare the duration to align the lower labial segment (33-43), between regular and irregular review groups from the micro-osteoperforations group.	Total treatment time needed to achieved lower labial segment alignment until Little's irregularity index 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	5 months
Primary	3. To compare the duration to align the lower labial segment (33-43), between micro-osteoperforations and control group in the regular review group.	Total treatment time needed to achieved lower labial segment alignment until Little's irregularity index 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	5 months
Primary	4. To compare the duration to align the lower labial segment (33-43), between micro-osteoperforations and control group in the irregular review group.	Total treatment time needed to achieved lower labial segment alignment until Little's irregularity index 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	5 months
Secondary	Total volume of root resorption with micro-osteoperforations group vs the control group	Total volume of root resorption in cubic millimeter (mm3) using 3D Cone Beam CT imaging scanner compare at baseline and end of LLS alignment	5 months
Secondary	Gingival recession between micro-osteoperforations and control group.	Gingival recession assessed in millimetre (mm) from cement-enamel junction (CEJ) to free gingival margin using electric digital calliper with an accuracy of 0.01mm, at baseline and end LLS alignment	5 months
Secondary	Black triangle between micro-osteoperforations and control group.	Presence of black triangle for interdental at baseline and end of LLS alignment	5 months