Efficiency of Piezotome-Corticision Assisted Orthodontics

Pain Perception Clinical Trial

Official title:

Efficiency of Piezotome-Corticision Assisted Orthodontics in Alleviating Mandibular Anterior Crowding - A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02026258
• Other study ID #: IE-12-047-2
• Status: Completed
• Phase: N/A
• First received: December 23, 2013
• Last updated: July 31, 2017
• Start date: December 2011
• Est. completion date: January 2016

Study information

• Verified date: July 2017
• Source: UConn Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the hypothesis that a piezotome-corticision procedure will have a transient acceleratory effect on the rate of tooth alignment and the overall treatment time. In addition, the subjects in the piezotome-corticision orthodontics group will experience a different level of pain, comfort, and satisfaction as opposed to the conventional orthodontics group.

Description:

This study will specifically try:

1. To compare the time required to achieve complete alignment of crowded mandibular anterior teeth (canine to canine) between piezotome-corticision assisted and conventional orthodontics.

2. To investigate the rate of alignment of mandibular anterior teeth at different time points until complete alignment is achieved using dental casts taken at every visit.

3. To compare subject's perception of pain, comfort and satisfaction between the piezotome-corticision assisted and conventional orthodontics using two questionnaires.

Eligibility criteria includes:

• Adult patients 18 or older

• Single arch or double arch treatment

• Non-extraction treatment in the mandibular arch

• Presence of full complement dentition from first molar to first molar

• No spaces in the mandibular arch

• Mandibular anterior irregularity index greater than 5

• Patient with healthy periodontium and attachment loss of up to 2mm

• The amount of crowding should allow for bracket placement

• No therapeutic intervention planned involving intermaxillary or other intraoral or extraoral appliances including elastics, lip bumpers, maxillary expansion appliances, or headgear prior to the complete alignment of mandibular anterior teeth.

Exclusion criteria includes:

• Failure to provide oral and written consent to participation

• Medical problems that affect tooth movement (Refer to Appendix I)

• Presence of primary teeth in the mandibular anterior area

• Missing permanent mandibular anterior teeth

• Inability to place brackets in the anterior mandibular teeth

• Breakage of any of the mandibular anterior brackets that have not been replaced within a week

Outcome measures

1. Two outcome assessors will be calibrated in the assessment of the Little's irregularity index. The irregularity index will be measured twice by two blinded outcome assessors using a fine-tip digital caliper.

2. The subjects will be instructed to record their level of pain: immediately, 1 hour, 12 hours, and 7 days after the first wire placement [76, 82]. They will be also asked to report if they had taken any pain medications, their level of ease and satisfaction with the procedure, if they would undergo this procedure again, and if they would recommend it to a friend. A 100 mm Visual Analog Scale (VAS) will be used to evaluate the level of pain, ease, and satisfaction of all the subjects, with anchors at each end of the line that read "no pain (easy, satisfied)" (0 mm) and "most pain (complicated, not satisfied)" (100 mm).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Adult patients 18 or older

• Single arch or double arch treatment

• Non-extraction treatment in the mandibular arch

• Presence of full complement dentition from first molar to first molar

• No spaces in the mandibular arch

• Mandibular anterior irregularity index greater than 5

• Patient with healthy periodontium and attachment loss of up to 2mm

• The amount of crowding should allow for bracket placement

• No therapeutic intervention planned involving intermaxillary or other intraoral or extraoral appliances including elastics, lip bumpers, maxillary expansion appliances, or headgear prior to the complete alignment of mandibular anterior teeth.

Exclusion criteria:

• Failure to provide oral and written consent to participation

• Medical problems that affect tooth movement (Refer to Appendix I)

• Presence of primary teeth in the mandibular anterior area

• Missing permanent mandibular anterior teeth

• Inability to place brackets in the anterior mandibular teeth

• Breakage of any of the mandibular anterior brackets that have not been replaced within a week

Related Conditions & MeSH terms

• Mandibular Anterior Crowding
• Pain Perception
• Piezocision

Intervention

Procedure:
• Piezotome-Corticision
Local anesthetic will be administered to the labial sulcus of the mandibular incisors. A scalpel will be used to make three vertical incisions through the gingiva, 4mm below the interdental papilla, interproximally between mandibular canines and lateral incisors, and central incisors on the labial aspect of the mandible. The incisions will be 4mm in length. A piezosurgery knife will be used to create the cortical alveolar incisions to a depth of 1mm within the cortical bone. The depth of the cortical incision will be limited to 1mm for a safety margin. Postoperatively, subjects will be advised to rinse with chlorhexidine mouthwash twice a day for one week and take acetaminophen as needed.

Device:
• Orthodontics
Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment.

Locations

Country	Name	City	State
United States	Orthodontic Clinic University of Connecticut	Farmington	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
UConn Health

Country where clinical trial is conducted

United States, 

References & Publications (33)

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. — View Citation

Baloul SS, Gerstenfeld LC, Morgan EF, Carvalho RS, Van Dyke TE, Kantarci A. Mechanism of action and morphologic changes in the alveolar bone in response to selective alveolar decortication-facilitated tooth movement. Am J Orthod Dentofacial Orthop. 2011 Apr;139(4 Suppl):S83-101. doi: 10.1016/j.ajodo.2010.09.026. — View Citation

Bogoch E, Gschwend N, Rahn B, Moran E, Perren S. Healing of cancellous bone osteotomy in rabbits--Part I: Regulation of bone volume and the regional acceleratory phenomenon in normal bone. J Orthop Res. 1993 Mar;11(2):285-91. — View Citation

Buschang PH, Campbell PM, Ruso S. Accelerating tooth movement with corticotomies: is it possible and desirable? Semin Orthod 2012;18:286-294.

Chung KR, Kim SH, Lee BS. Speedy surgical-orthodontic treatment with temporary anchorage devices as an alternative to orthognathic surgery. Am J Orthod Dentofacial Orthop. 2009 Jun;135(6):787-98. doi: 10.1016/j.ajodo.2007.03.036. — View Citation

Cohen G, Campbell PM, Rossouw PE, Buschang PH. Effects of increased surgical trauma on rates of tooth movement and apical root resorption in foxhound dogs. Orthod Craniofac Res. 2010 Aug;13(3):179-90. doi: 10.1111/j.1601-6343.2010.01494.x. — View Citation

Dibart S, Surmenian J, Sebaoun JD, Montesani L. Rapid treatment of Class II malocclusion with piezocision: two case reports. Int J Periodontics Restorative Dent. 2010 Oct;30(5):487-93. — View Citation

Fischer TJ. Orthodontic treatment acceleration with corticotomy-assisted exposure of palatally impacted canines. Angle Orthod. 2007 May;77(3):417-20. — View Citation

Fitzpatrick BN. Corticotomy. Aust Dent J. 1980 Oct;25(5):255-8. — View Citation

Fleming PS, DiBiase AT, Sarri G, Lee RT. Efficiency of mandibular arch alignment with 2 preadjusted edgewise appliances. Am J Orthod Dentofacial Orthop. 2009 May;135(5):597-602. doi: 10.1016/j.ajodo.2007.06.014. — View Citation

Frost HM. The regional acceleratory phenomenon: a review. Henry Ford Hosp Med J. 1983;31(1):3-9. Review. — View Citation

Gameiro GH, Pereira-Neto JS, Magnani MB, Nouer DF. The influence of drugs and systemic factors on orthodontic tooth movement. J Clin Orthod. 2007 Feb;41(2):73-8; quiz 71. — View Citation

Gantes B, Rathbun E, Anholm M. Effects on the periodontium following corticotomy-facilitated orthodontics. Case reports. J Periodontol. 1990 Apr;61(4):234-8. — View Citation

Generson RM, Porter JM, Zell A, Stratigos GT. Combined surgical and orthodontic management of anterior open bite using corticotomy. J Oral Surg. 1978 Mar;36(3):216-9. — View Citation

Hernández-Alfaro F, Guijarro-Martínez R. Endoscopically assisted tunnel approach for minimally invasive corticotomies: a preliminary report. J Periodontol. 2012 May;83(5):574-80. doi: 10.1902/jop.2011.110233. Epub 2011 Sep 26. — View Citation

Iino S, Sakoda S, Ito G, Nishimori T, Ikeda T, Miyawaki S. Acceleration of orthodontic tooth movement by alveolar corticotomy in the dog. Am J Orthod Dentofacial Orthop. 2007 Apr;131(4):448.e1-8. — View Citation

Kim SJ, Park YG, Kang SG. Effects of Corticision on paradental remodeling in orthodontic tooth movement. Angle Orthod. 2009 Mar;79(2):284-91. doi: 10.2319/020308-60.1. — View Citation

KOLE H. Surgical operations on the alveolar ridge to correct occlusal abnormalities. Oral Surg Oral Med Oral Pathol. 1959 May;12(5):515-29 concl. — View Citation

Lee WC. Experimental study of the effect of prostaglandin administration on tooth movement--with particular emphasis on the relationship to the method of PGE1 administration. Am J Orthod Dentofacial Orthop. 1990 Sep;98(3):231-41. — View Citation

Liou EJ, Huang CS. Rapid canine retraction through distraction of the periodontal ligament. Am J Orthod Dentofacial Orthop. 1998 Oct;114(4):372-82. — View Citation

Long H, Pyakurel U, Wang Y, Liao L, Zhou Y, Lai W. Interventions for accelerating orthodontic tooth movement: a systematic review. Angle Orthod. 2013 Jan;83(1):164-71. doi: 10.2319/031512-224.1. Epub 2012 Jun 21. Review. — View Citation

Mostafa YA, Mohamed Salah Fayed M, Mehanni S, ElBokle NN, Heider AM. Comparison of corticotomy-facilitated vs standard tooth-movement techniques in dogs with miniscrews as anchor units. Am J Orthod Dentofacial Orthop. 2009 Oct;136(4):570-7. doi: 10.1016/j.ajodo.2007.10.052. — View Citation

Ngan P, Kess B, Wilson S. Perception of discomfort by patients undergoing orthodontic treatment. Am J Orthod Dentofacial Orthop. 1989 Jul;96(1):47-53. — View Citation

Ren A, Lv T, Kang N, Zhao B, Chen Y, Bai D. Rapid orthodontic tooth movement aided by alveolar surgery in beagles. Am J Orthod Dentofacial Orthop. 2007 Feb;131(2):160.e1-10. — View Citation

Sanjideh PA, Rossouw PE, Campbell PM, Opperman LA, Buschang PH. Tooth movements in foxhounds after one or two alveolar corticotomies. Eur J Orthod. 2010 Feb;32(1):106-13. doi: 10.1093/ejo/cjp070. Epub 2009 Sep 7. — View Citation

Scheurer PA, Firestone AR, Bürgin WB. Perception of pain as a result of orthodontic treatment with fixed appliances. Eur J Orthod. 1996 Aug;18(4):349-57. — 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

Vercellotti T, Podesta A. Orthodontic microsurgery: a new surgically guided technique for dental movement. Int J Periodontics Restorative Dent. 2007 Aug;27(4):325-31. — View Citation

Verna C, Dalstra M, Melsen B. The rate and the type of orthodontic tooth movement is influenced by bone turnover in a rat model. Eur J Orthod. 2000 Aug;22(4):343-52. — View Citation

Wang L, Lee W, Lei DL, Liu YP, Yamashita DD, Yen SL. Tisssue responses in corticotomy- and osteotomy-assisted tooth movements in rats: histology and immunostaining. Am J Orthod Dentofacial Orthop. 2009 Dec;136(6):770.e1-11; discussion 770-1. doi: 10.1016/j.ajodo.2009.05.015. — View Citation

Wilcko MT, Wilcko WM, Pulver JJ, Bissada NF, Bouquot JE. Accelerated osteogenic orthodontics technique: a 1-stage surgically facilitated rapid orthodontic technique with alveolar augmentation. J Oral Maxillofac Surg. 2009 Oct;67(10):2149-59. doi: 10.1016/j.joms.2009.04.095. — View Citation

Wilcko WM, Wilcko T, Bouquot JE, Ferguson DJ. Rapid orthodontics with alveolar reshaping: two case reports of decrowding. Int J Periodontics Restorative Dent. 2001 Feb;21(1):9-19. — View Citation

Yamasaki K, Shibata Y, Fukuhara T. The effect of prostaglandins on experimental tooth movement in monkeys (Macaca fuscata). J Dent Res. 1982 Dec;61(12):1444-6. — View Citation

* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Days to Complete Alignment of Mandibular Anterior Teeth Based on Little's Irregularity Index	Days until complete alignment of mandibular anterior alignment was achieved after wire insertion on both groups. Complete alignment was based on Little's Irregularity index (Sum of contact displacement in mm between the anterior teeth from mesial of one canine to the mesial of the contralateral canine) of less than 2mm.	From the placement of the first wire to complete alignment of mandibular anteiror teeth, assessed up to 9 months
Secondary	Questionnaires Involving Pain Level	Specific questions questionnaire included: 1) How much pain/discomfort at the following time points? 1) Immediately after first wire placement (T0), 2) 1 hour, (T1) 3) 12 hrs (T2) and 4) Seven days after (T3). Rated on a scale from 0-100 (No pain-Unbearable pain)	Immediate to 1 week after wire placement (T0-T3)
Secondary	Questionnaire on Easiness and Satisfaction With the Procedure	Visual analogue Scale from 0-100; Are you satisfied with your treatment? Very- Not Satisfied (0-100); How easy was the procedure to you? Easy-Complicated (0-100)	4-5 weeks after first wire placement
Secondary	Questionnaire Involving Pain Management and Satisfaction With the Procedure	Binomial measurement in questionnaire on medications taken and satisfaction with the procedure; Did you take any pain medication after the procedure? Y/N (Count Yes); Would you undergo this procedure again? Y/N (Count Yes); Would you recommend this procedure to a friend? Y/N (Count Yes)	4-5 weeks after first wire placement