Efficacy of Minimally Invasive Surgical Technique in Accelerating Orthodontic Treatment

NCT02606331 | Completed DMC

• 1 other identifier: UDDS-Ortho-03-2015
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Thirty six patients needs therapeutic extraction of the maxillary first premolars with subsequent retraction of the maxillary canines will be divided randomly into two groups : piezocision group and the ER:yttrium aluminum garnet (YAG) laser group. In each group, piezocision or hard laser-assisted flapless corticotomy will randomly assigned to one side of the maxillary arch at the first premolar region, and the other side served as the control. Canine retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side, soldered trans-palatal arch will be used as an anchor unit. Pre- and post distalization dental casts will be evaluated to study rate of canine distalization, canine rotation and anchorage loss over a follow-up period until a Class I canine relationship is achieved. The levels of pain and discomfort will be self-reported using a questionnaire with visual analog scales administered at four assessment times during the first month after the minimally invasive procedure.

Conditions

Malocclusion, Angle Class II

Outcome Measures

Primary Outcomes (1)

• Rate of canine retraction

  The distance traveled by mm is divided by the time required in weeks.

  This will be measured immediately at the end of the tooth movement, i.e. when the retracted canine reaches its final position which takes up to 12 weeks

Secondary Outcomes (3)

• Rate of molar anchorage loss

  This will be measured immediately at the end of the tooth movement, i.e. when the retracted canine reaches its final position which may take up to 12 weeks

• Change in canine rotation

  This will be measured at the following assessment times: T1: baseline, T2: after 4 weeks of canine retraction, T3: after 8 weeks of canine retraction, T4: when the canine reaches its final position up to 12 weeks

• Change in the levels of pain and discomfort

  These levels will be assessed at: one day following the intervention, one week, two weeks, and four weeks following the intervention.

Study Arms (2)

Piezosurgery

EXPERIMENTAL

In one half of the dental arch, piezosurgery will be performed for canine retraction, whereas in the other half ordinary canine retraction procedure will be followed.

Procedure: Piezosurgery

ER:YAG Laser

EXPERIMENTAL

In one half of the dental arch, ER:YAG laser irradiation will be performed for canine retraction, whereas in the other half ordinary canine retraction procedure will be followed.

Radiation: ER:YAG laser

Interventions

Piezosurgery PROCEDURE

Corticotomy cuts will be performed by this technique.

Piezosurgery

ER:YAG laser RADIATION

Corticotomy cuts will be performed by this technique.

ER:YAG Laser

Eligibility Criteria

• Age: 14 Years - 27 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adult healthy patients , Male and female , Age range: 15-27 years.
• Class II Division 1 malocclusion :
• Mild / moderate skeletal Class II (sagittal discrepancy angle ≤7)
• Overjet ≤10
• Normal or excessive facial height (Clinically and then cephalometrically assessed using these three angles : mandibular/cranial base angle, maxillary/mandibular plane angle and facial axis angle)
• Mild to moderate crowding ≤ 4
• Permanent occlusion.
• Existence of all the upper teeth (except third molars).
• Good oral and periodontal health:
• Probing depth \< 4 mm
• No radiographic evidence of bone loss .
• Gingival index ≤ 1
• Plaque index ≤ 1

You may not qualify if:

• Medical problems that affect tooth movement (corticosteroid, nonsteroidal antiinflammatory drugs (NSAIDs), …)
• patients have anti indication for oral surgery ( medical - social - psycho)
• Presence of primary teeth in the maxillary arch
• Missing permanent maxillary teeth (except third molars).
• Poor oral hygiene or Current periodontal disease:
• Probing depth ≥ 4 mm
• radiographic evidence of bone loss
• Gingival index \> 1
• Plaque index \> 1
• Patient had previous orthodontic treatment

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Orthodontics, University of Damascus Dental School

Damascus, Rif-dimashq Governorate, DM20AM18, Syria

Location

Related Publications (6)

• Aksakalli S, Calik B, Kara B, Ezirganli S. Accelerated tooth movement with piezocision and its periodontal-transversal effects in patients with Class II malocclusion. Angle Orthod. 2016 Jan;86(1):59-65. doi: 10.2319/012215-49.1. Epub 2015 May 19.

  PMID: 25989211 BACKGROUND

• 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.

  PMID: 24182579 BACKGROUND

• Al-Naoum F, Hajeer MY, Al-Jundi A. Does alveolar corticotomy accelerate orthodontic tooth movement when retracting upper canines? A split-mouth design randomized controlled trial. J Oral Maxillofac Surg. 2014 Oct;72(10):1880-9. doi: 10.1016/j.joms.2014.05.003. Epub 2014 May 14.

  PMID: 25128922 BACKGROUND

• Aboul-Ela SM, El-Beialy AR, El-Sayed KM, Selim EM, El-Mangoury NH, Mostafa YA. Miniscrew implant-supported maxillary canine retraction with and without corticotomy-facilitated orthodontics. Am J Orthod Dentofacial Orthop. 2011 Feb;139(2):252-9. doi: 10.1016/j.ajodo.2009.04.028.

  PMID: 21300255 BACKGROUND

• Hoogeveen EJ, Jansma J, Ren Y. Surgically facilitated orthodontic treatment: a systematic review. Am J Orthod Dentofacial Orthop. 2014 Apr;145(4 Suppl):S51-64. doi: 10.1016/j.ajodo.2013.11.019.

  PMID: 24680025 BACKGROUND

• Alfawal AMH, Hajeer MY, Ajaj MA, Hamadah O, Brad B. Evaluation of piezocision and laser-assisted flapless corticotomy in the acceleration of canine retraction: a randomized controlled trial. Head Face Med. 2018 Feb 17;14(1):4. doi: 10.1186/s13005-018-0161-9.

  PMID: 29454369 DERIVED

MeSH Terms

Conditions

Malocclusion, Angle Class II

Interventions

Piezosurgery; Lasers, Solid-State

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Surgical Procedures; Surgical Procedures, Operative; Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Alaa Alfawal, DDS

  MSc student at the Orthodontic Department, University of Damascus Dental School

  PRINCIPAL INVESTIGATOR

• Mohammad Y Hajeer, DDS MSc PhD

  Associate Professor of Orthodontics, University of Damascus Dental School

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2015
• First Posted: November 17, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 10, 2016

Record last verified: 2016-06

Locations

SY (1)