Pain Perception Clinical Trial
Official title:
Efficiency of Piezotome-Corticision Assisted Orthodontics in Alleviating Mandibular Anterior Crowding - A Randomized Controlled Clinical Trial
Verified date | July 2017 |
Source | UConn Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Orthodontic Clinic University of Connecticut | Farmington | Connecticut |
Lead Sponsor | Collaborator |
---|---|
UConn Health |
United States,
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* Note: There are 33 references in all — Click here to view all references
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 |
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