laser
Effect of Er,Cr: YSGG Laser - Aided Circumferential Supracrestal Fiberotomy in the Prevention of the Lower Incisors Rotational Relapse
Sponsor study identifier
interventional
60
1 country
1
Study Start
March 2021
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Primary Completion
March 2021
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Study Completion
June 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
To establish the effect of erbium, chromium,yttrium,scandium,gallium and garnet (Er,Cr: YSGG) laser-aided circumferential supracrestal fiberotomy compared to a conventional circumferential supracrestal fiberotomy group, after leveling and alignment during the first month after arch wire removal on the prevention of rotational relapse in lower incisors. Methods: Randomized clinical trial in 60 orthodontic patients with two to four lower incisors rotation between 30º-50º degrees before treatment.They are going to be assigned in two intervention groups, each group with 30 patients. One group are going to be treated with Er;Cr: YSGG laser -aided CSF and the other group with conventional circumferential supracrestal fiberotomy. After leveling and alignment each procedure will be performed and after one month healing the arch wire will be removed for a month and lower incisor relapse will be measured through cast models in a software. Periodontal parameters will be registered before and after procedures.The outcomes are going to be determined and compared between groups with corresponding statistical test and results will be analyzed
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2021
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 7, 2020
Actual (reported)May 12, 2020
Actual (reported)March 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2021
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June 2021
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Quantity of anterior mandibular rotation relapse
Er,Cr.YSGG laser-aided fiberotomy and Conventional CSF. Alginate impressions and cast models at the beginning of the study.Herb curve to measure the initial rotation grade. Impressions and measurements after the leveling and alignment phase, fiberotomy procedure, retention for one healing month. 30 days later of the removal of the arch wire, alginate impressions and measures will be taken by previously-calibrated operators
one month after arch wire removal
Changes in probing depth
baseline and two months after fiberotomy
Changes in clinical crown height
baseline and two months after fiberotomy
Pain levels
after procedures, 24, 48 and 72 hours
Experimental: Er, Cr: YSGG laser-aided Circumferential Supracrestal Fiberotomy in the lower arch, posterior leveling and alignment of the orthodontic treatment by inserting the laser tip at an angle of 10-15º to the radicular surface
Fiberotomy comparator: this arm is going to receive a blade conventional Circumferential Supracrestal Fiberotomy in the lower arch, posterior leveling and alignment by inserting a surgical blade into the gingival sulcus at an angle like that in the laser-aided CSF.
After injection 2% lidocaine with 1:80.000 epinephrine concentration in labial and lingual vestibule the fiberotomy is carried out by inserting a 9 x 0.5 mm laser tip into the gingival sulcus with an angle of 10-15º to the radicular surface
After injection 2% lidocaine with 1:80.000 epinephrine concentration in labial and lingual vestibule the fiberotomy is carried out by inserting a surgical blade (#11)into the gingival sulcus at an angle of 10-15º to the radicular surface
Orthodontic Clinic of Post-graduation Program UniCIEO
Bogotá, Bogota D.C., 110011, Colombia
Sonia Plaza, Ms.
Fundación Universitaria CIEO
First Submitted
May 7, 2020
First Posted
May 12, 2020
Study Start
March 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
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March 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 26, 2021
Record last verified: 2021-02
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Source: ClinicalTrials.gov.
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