Er,Cr:YSGG Laser-aided Fiberotomy in the Prevention of the Lower Incisors Rotational Relapse

NCT04384237 | Unknown

• 1 other identifier: CIEO
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rotated Teeth

Keywords

Conventional supracrestal Fiberotomy; Laser -aided Fiberotomy; Er;Cr:YSGG Laser; Incisors rotation relapse

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

Study Arms (2)

Er,Cr:YSGG laser-aided CSF

EXPERIMENTAL

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

Procedure: Er,Cr:YSGG laser-aided CSF

Conventional CSF

ACTIVE COMPARATOR

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.

Procedure: Conventional CSF

Interventions

Er,Cr:YSGG laser-aided CSF PROCEDURE

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

Er,Cr:YSGG laser-aided CSF

Conventional CSF PROCEDURE

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

Conventional CSF

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non gingivitis or untreated caries
• lower teeth with 30º-50º rotation degree
• mm keratinized tissue band
• at least 2 rotated mandibular teeth

You may not qualify if:

• Root canal treatment
• Marginal Recessions
• Interproximal bone loss in Rx
• Thin gingival biotype (periodontal probe translucency
• Reduced periodontium
• systemic diseases or medications that alters bone metabolism.
• Pregnancy

Sponsors & Collaborators

• Fundación Universitaria CIEO: lead

Study Sites (1)

Orthodontic Clinic of Post-graduation Program UniCIEO

Bogotá, Bogota D.C., 110011, Colombia

Location

Study Officials

• Sonia Plaza, Ms.

  Fundación Universitaria CIEO

  STUDY DIRECTOR

Central Study Contacts

Sandra G Leal Pinilla, Ms.

CONTACT

317 383 3691; sg.leal@unicieo.edu.co

Liliana Sanz Tobon, DDS

CONTACT

321 465 0456; sanztobon@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single (outcomes Assessor) An external clinic is going to do the measures
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Docent

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 12, 2020
• Study Start: March 1, 2021
• Primary Completion: March 1, 2021
• Study Completion: June 1, 2021
• Last Updated: February 26, 2021

Record last verified: 2021-02

Locations

CO (1)