Rotated TeethlaserNCT04384237
Er,Cr:YSGG Laser-aided Fiberotomy in the Prevention of the Lower Incisors Rotational Relapse
A study testing Er,Cr:YSGG laser-aided CSF and Conventional CSF in people with Rotated Teeth, run by Fundación Universitaria CIEO at 1 site in Colombia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotated Teeth
- What is being tested?
- Er,Cr:YSGG laser-aided CSF and Conventional CSF
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteColombia
- Study dates
- Mar 2021to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non gingivitis or untreated caries
- lower teeth with 30º-50º rotation degree
- 2 mm keratinized tissue band
- at least 2 rotated mandibular teeth
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Orthodontic Clinic of Post-graduation Program UniCIEO
Bogotá, Bogota D.C., 110011
Sandra G Leal Pinilla, Ms., 317 383 3691, sg.leal@unicieo.edu.co
Liliana Sanz Tobon, DDS, 321 465 0456, sanztobon@hotmail.com
About this study
Official title: Effect of Er,Cr: YSGG Laser - Aided Circumferential Supracrestal Fiberotomy in the Prevention of the Lower Incisors Rotational Relapse
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
Read the detailed description
(Population, intervention, comparison, outcomes )PICO QUESTION Is there any difference in the amount of rotational relapse of the anterior lower teeth after leveling and alignment between Er;Cr:YSGG laser-aided circumferential supracrestal fiberotomy compared with conventional circumferential supracrestal fiberotomy after the removal of the arch wire one month once healed?
Population: Orthodontic patients with lower incisors rotation between 30º-50º degrees
Intervention:Er:Cr;YSGG Laser-aided CSF (Waterlase, Biolase, Irvine,California, USA) Comparison: Conventional CSF
Outcomes Primary Outcome: rotation relapse degree after one month removed teeth from the arch wire Secondary Outcome: probing depth and clinical crown height (gingival margin position)baseline, after leveling and alignment stage one month removed lower incisors from the arch wire.
AIMS
GENERAL AIM
To establish the effect of Er,Cr: YSGG laser -aided circumferential supracrestal fiberotomy compared to a conventional circumferential supracrestal fiberotomy group on the prevention of rotational relapse in lower incisors, during the first month after the teeth are removed from the arch.
SPECIFIC AIMS
- Determine the degree of rotation of the lower incisors in the two groups of the pretreatment study, at the end of the alignment and leveling stage and the month after performing the intervention.
- Determine the probing depth and the position of the gingival margin of the lower incisors in the two groups of the pretreatment study, at the end of the alignment and leveling stage and the month after performing the intervention.
- Determine the perception of pain in patients of the two study groups at baseline, 24, 48 and 72 hours.
- Compare rotational relapse, probing depth, gingival margin position in each study group during the follow-up time.
- Compare rotational relapse, probing depth and gingival margin position between study groups during follow-up time.
METHODS
OVERVIEW OF DESIGN Study design: Randomized clinical trial
Randomized clinical trial in 60 lower incisors with moderate initial rotation (30-50 degrees). The eligible patients are going to be randomly allocated into two groups, each group with 30 teeth.
One group is going to be treated with Er,Cr:YSGG laser - aided circumferential supracrestal fiberotomy and the other group with conventional circumferential supracrestal fiberotomy.
Blinding: it is not possible to blind patients and clinical staff, but the investigators are going to blind the operator who will perform the measurements and the data analysis (single-blinded)
The protocol for both procedures will be the same except for the intervention.
Alginate impressions and cast models at the beginning of the study will be taken and initial rotation of mandibular incisors will be measured based on a Xerox copy of the lower cast (Canon Xerox Machine, imageRUNNER (IR) 5050 Ota, Tokyo, Japan) while the occlusal table faced down on the screen, a Xerox copy of it will be made. The Xerox copies will be scanned (Canon CanoScan 9000F Mark II, Ota, Tokyo, Japan) and saved as a image file format JPEG (Joint Photographic Experts Group) files. The files will be imported to the software to drawn an imaginary arch passing through the outermost surface of the anterior and posterior teeth.
To measure the initial rotation, the JPEG images will be opened in a Digimizer image analysis software (Version 4.3 Orange, California)The angle between the incisor edge and the line tangent to the imaginary arch will be measured as initial rotation.
Measures of lower incisors will be taken by previously-calibrated operators as well as periodontal measurements at baseline, after leveling and alignment and one month after separating the teeth from the arch wire.
Pain measurement evaluations will be determined by the visual analogue scale (VAS) at baseline, 24,48 y 72 hrs.
DESIGN FOR SAMPLING
Study Population:
-Orthodontic patients from the orthodontic department clinics of the UniCieo
Sampling:
No probabilistic: convenience sample Consecutive sample of consenting patients
PLANS FOR RECRUITMENT
Patients of the Clinic University (UniCieo) that meet the selection criteria and accept to participate.
MEASUREMENTS
MAIN PREDICTOR VARIABLE
-Relapse lower incisors (Er;Cr YSGG laser-aided CSF)
POTENTIAL CONFOUNDING
Age
Sex
OUTCOME VARIABLES
Dental stone cast scanned Outcomes (T3-T4):
-Quantity of lower anterior teeth rotation relapse tendency measured 1 month after arch wire removed
Periodontal Outcomes:
Quantity of probing depth and gingival margin position (coronal height) measured 1 month after arch wire removed
Pain Outcomes:
Visual analogue scale (0-10) measures after clinical intervention
STATISTICAL ISSUES
APPROACH TO STATISTICAL ANALYSIS
The data analysis will be processed in the statistics program Statistical Package for the Social Sciences (SPSS) software (version 21, Chicago, IL).Evaluation of normality of data will be valued with the Kolmogorov-Smirnov test. One-way ANOVA will be used to determine any significant differences Significance level is going to be set at P< 0.05
- Conditions
- Rotated Teeth
- Being tested
- Er,Cr:YSGG laser-aided CSF, Conventional CSF
- Keywords
- Conventional supracrestal Fiberotomy, Laser -aided Fiberotomy, Er;Cr:YSGG Laser, Incisors rotation relapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Er,Cr:YSGG laser-aided CSFProcedure or surgery
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
Conventional CSFProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Procedure: Conventional CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one month after arch wire removal
Secondary outcomes (3)
Changes in probing depth
At the beginning of the study, two months after fiberotomy, measures will be taken by calibrated operators
Measured: baseline and two months after fiberotomy
Changes in clinical crown height
At the beginning of the study, two months after fiberotomy, measures will be taken by calibrated operators
Measured: baseline and two months after fiberotomy
Pain levels
Pain levels will be measure by the Visual Analog Scale (VAS), from 0 to 10-cm VAS, where the number 0 indicating no pain, a value less than 4 on the EVA means mild pain, between 4 and 6 moderate pain, greater than 6 very intense pain and the number 10 indicating the most severe pain into the scale, after 24, 48 and 72 hours CSF procedures
Measured: after procedures, 24, 48 and 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study startMar 2021 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotated TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Universitaria CIEO
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Leal, Fundación Universitaria CIEO
- Investigators
- Sonia Plaza, Ms., Study director, Fundación Universitaria CIEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384237
- Sponsor's protocol ID
- CIEO
- Acronym
- laser
- Status last verified
- Feb 2021
- First submitted
- 7 May 2020
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Er,Cr: YSGG Laser - Aided Circumferential Supracrestal Fiberotomy in the Prevention of the Lower Incisors Rotational Relapse
- ClinicalTrials.gov ID
- NCT04384237
- Acronym / sponsor ID
- laser / CIEO
- Conditions
- Rotated Teeth
- Keywords
- Conventional supracrestal Fiberotomy, Laser -aided Fiberotomy, Er;Cr:YSGG Laser, Incisors rotation relapse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fundación Universitaria CIEOUniversity, hospital or other
- Study start
- Mar 2021 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
(Population, intervention, comparison, outcomes )PICO QUESTION Is there any difference in the amount of rotational relapse of the anterior lower teeth after leveling and alignment between Er;Cr:YSGG laser-aided circumferential supracrestal fiberotomy compared with conventional circumferential supracrestal fiberotomy after the removal of the arch wire one month once healed?
Population: Orthodontic patients with lower incisors rotation between 30º-50º degrees
Intervention:Er:Cr;YSGG Laser-aided CSF (Waterlase, Biolase, Irvine,California, USA) Comparison: Conventional CSF
Outcomes Primary Outcome: rotation relapse degree after one month removed teeth from the arch wire Secondary Outcome: probing depth and clinical crown height (gingival margin position)baseline, after leveling and alignment stage one month removed lower incisors from the arch wire.
AIMS
GENERAL AIM
To establish the effect of Er,Cr: YSGG laser -aided circumferential supracrestal fiberotomy compared to a conventional circumferential supracrestal fiberotomy group on the prevention of rotational relapse in lower incisors, during the first month after the teeth are removed from the arch.
SPECIFIC AIMS
- Determine the degree of rotation of the lower incisors in the two groups of the pretreatment study, at the end of the alignment and leveling stage and the month after performing the intervention.
- Determine the probing depth and the position of the gingival margin of the lower incisors in the two groups of the pretreatment study, at the end of the alignment and leveling stage and the month after performing the intervention.
- Determine the perception of pain in patients of the two study groups at baseline, 24, 48 and 72 hours.
- Compare rotational relapse, probing depth, gingival margin position in each study group during the follow-up time.
- Compare rotational relapse, probing depth and gingival margin position between study groups during follow-up time.
METHODS
OVERVIEW OF DESIGN Study design: Randomized clinical trial
Randomized clinical trial in 60 lower incisors with moderate initial rotation (30-50 degrees). The eligible patients are going to be randomly allocated into two groups, each group with 30 teeth.
One group is going to be treated with Er,Cr:YSGG laser - aided circumferential supracrestal fiberotomy and the other group with conventional circumferential supracrestal fiberotomy.
Blinding: it is not possible to blind patients and clinical staff, but the investigators are going to blind the operator who will perform the measurements and the data analysis (single-blinded)
The protocol for both procedures will be the same except for the intervention.
Alginate impressions and cast models at the beginning of the study will be taken and initial rotation of mandibular incisors will be measured based on a Xerox copy of the lower cast (Canon Xerox Machine, imageRUNNER (IR) 5050 Ota, Tokyo, Japan) while the occlusal table faced down on the screen, a Xerox copy of it will be made. The Xerox copies will be scanned (Canon CanoScan 9000F Mark II, Ota, Tokyo, Japan) and saved as a image file format JPEG (Joint Photographic Experts Group) files. The files will be imported to the software to drawn an imaginary arch passing through the outermost surface of the anterior and posterior teeth.
To measure the initial rotation, the JPEG images will be opened in a Digimizer image analysis software (Version 4.3 Orange, California)The angle between the incisor edge and the line tangent to the imaginary arch will be measured as initial rotation.
Measures of lower incisors will be taken by previously-calibrated operators as well as periodontal measurements at baseline, after leveling and alignment and one month after separating the teeth from the arch wire.
Pain measurement evaluations will be determined by the visual analogue scale (VAS) at baseline, 24,48 y 72 hrs.
DESIGN FOR SAMPLING
Study Population:
-Orthodontic patients from the orthodontic department clinics of the UniCieo
Sampling:
No probabilistic: convenience sample Consecutive sample of consenting patients
PLANS FOR RECRUITMENT
Patients of the Clinic University (UniCieo) that meet the selection criteria and accept to participate.
MEASUREMENTS
MAIN PREDICTOR VARIABLE
-Relapse lower incisors (Er;Cr YSGG laser-aided CSF)
POTENTIAL CONFOUNDING
Age
Sex
OUTCOME VARIABLES
Dental stone cast scanned Outcomes (T3-T4):
-Quantity of lower anterior teeth rotation relapse tendency measured 1 month after arch wire removed
Periodontal Outcomes:
Quantity of probing depth and gingival margin position (coronal height) measured 1 month after arch wire removed
Pain Outcomes:
Visual analogue scale (0-10) measures after clinical intervention
STATISTICAL ISSUES
APPROACH TO STATISTICAL ANALYSIS
The data analysis will be processed in the statistics program Statistical Package for the Social Sciences (SPSS) software (version 21, Chicago, IL).Evaluation of normality of data will be valued with the Kolmogorov-Smirnov test. One-way ANOVA will be used to determine any significant differences Significance level is going to be set at P< 0.05
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Er,Cr:YSGG laser-aided CSF | Experimental | Procedure: Er,Cr:YSGG laser-aided CSFExperimental: 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 |
| Conventional CSF | Active comparator | Procedure: Conventional CSFFiberotomy 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Non gingivitis or untreated caries
- lower teeth with 30º-50º rotation degree
- 2 mm keratinized tissue band
- at least 2 rotated mandibular teeth
Key exclusion criteria (7 listed)
- Root canal treatment
- Marginal Recessions
- Interproximal bone loss in Rx
- Thin gingival biotype (periodontal probe translucency
- Reduced periodontium
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Er,Cr:YSGG laser-aided CSFAfter 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 | Procedure or surgery | Er,Cr:YSGG laser-aided CSF |
| Conventional CSFAfter 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 | Procedure or surgery | Conventional CSF |
Primary outcome
Quantity of anterior mandibular rotation relapse
Time frame: one month after arch wire removal
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
3 secondary outcomes
Changes in probing depth
Time frame: baseline and two months after fiberotomy
Changes in clinical crown height
Time frame: baseline and two months after fiberotomy
Pain levels
Time frame: after procedures, 24, 48 and 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonia Plaza, Ms. study director
Fundación Universitaria CIEO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Er,Cr:YSGG laser-aided CSF and Conventional CSF in people with Rotated Teeth, run by Fundación Universitaria CIEO at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandra G Leal Pinilla, Ms. (317 383 3691, sg.leal@unicieo.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantity of anterior mandibular rotation relapse (time frame: one month after arch wire removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021.