An interventional study of Laser Application for Dental Bleaching in Tooth Discoloration, sponsored by Universidad Nacional de Caaguazu. Completed at 1 site in Paraguay. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-19.
Sponsored by Universidad Nacional de Caaguazu · Not applicable, Interventional, and Treatment
Objective: To establish the efficacy of laser application with chemical treatment in dental bleaching compared to chemical treatment alone.
Methods: The investigators conducted a randomized controlled trial (RCT), single blind (evaluator), in 24 patients randomized to laser and chemical intervention (12) or chemical intervention aloe (12). The commercial products used were Whiteness Hp 35% Hydrogen Peroxide and the LASER of DCM Equipments. The trial outcome measures were obtained using the Vita EasyShade Spectrophotometer and the International CIELCh system. To stablish differences before vs. after treatments and between groups, the T test and chi2 tests were applied.
New technologies continue to be launched in the field of dental esthetics, especially for whitening, and many products advertise their efficacy. One new approach is the use of LASER technology which has been purported to be the most powerful font light for bleaching Diverse studies by different designs find different efficacies for LASER whitening Randomized clinical trials (RCT) are needed for the most rigorous confirmation of efficacy. RCT are able to control for characteristics that can cause bias, including factors related to dental care such as diet and cleaning behavior after the bleaching procedure. The investigators therefore conducted an RCT to make a side by side comparison of a LASER whitening technique with chemical bleaching versus chemical bleaching without LASER.
Intervention: After the patient was informed and sign the consent; a dental prophylaxis was done. Three days later the bleaching procedure started following the same protocol regarding to the time and product used (35% Hydrogen Peroxide Whitening HP, 40 minutes divided in two phases of 20 minutes each one) from premolar to premolar in superior and inferior teeth. The difference was that one of the intervention groups used the Laser for ten minutes (starting at the minute 5) and the other did not.. The Laser used was the Whitening Lase II (DCM EQUIPMENTS).
The measure of the color was done to the superior canines by just one evaluator in three stages: before bleaching (baseline), 15 minutes after bleaching, and three days after. It was done with the Vita Easyshade Spectrophotometer.
The dental sensitivity also was asked at the three time points; however, as an exclusion criterion the level had to be 0 to be entered into the study.
All the patients received verbal and written instructions about eating and cleaning behavior. Cleaning materials for the three days after procedure were given.
As the clinical endpoint, the difference in color was calculated using the international accepted system CIELCh (11,18-19). The formula is ∆E* = [(∆L*)2 + (∆C*)2 + (∆h*)2] ½; were L is Luminosity, C is Chroma and h is Hue.
A verbal numeric scale was used to determine the dental sensitivity with values from 0 to 3. The evaluator used the water and air from the dental chair syringe. The patient reports 0 for no sensitivity; 1 for slight sensitivity, 2 for moderate sensitivity, and 3 for severe sensitivity.
105 studies on the registry are indexed under Tooth Discoloration; 19 are open to participants now.
This study's enrollment of 24 is below the median of 48 across 97 interventional studies indexed under Tooth Discoloration.
Browse Tooth Discoloration studies →Universidad Nacional de Caaguazu is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
35% Hydrogen Peroxide (Whitening HP, FGM SC Brazil) 40 minutes divided in two phases of 20 minutes each one (5 minutes colocation, 10 minutes Laser Application and 5 minutes moving the product) from premolar to premolar in superior and inferior teeth. Experimental
Device: Laser Application for Dental Bleaching
35% Hydrogen Peroxide (Whitening HP FGM SC Brazil), 40 minutes divided in two phases of 20 minutes each one (5 minutes colocation, 10 minutes waiting and 5 minutes moving the product) from premolar to premolar in superior and inferior teeth. No Laser Application No Intervention
The Laser used was the Whitening Lase II (DCM EQUIPMENTS).
Dental Color Stage 1(Before Intervention)
The measure of the color was done to the superior canines by just one evaluator. It was done with the Vita Easyshade Spectrophotometer. To improve precision off the data, measures were taken 3 times in all superior canines studied. The Investigators used the values L, C,H.
Time frame: through study completion, an average of 3 days
Dental Color Stage 2 (30 minutes after dental bleaching)
The measure of the color was done to the superior canines by just one evaluator. It was done with the Vita Easyshade Spectrophotometer. To improve precision off the data, measures were taken 3 times in all superior canines studied. The Investigators used the values L, C,H.
Time frame: through study completion, an average of 3 days
Dental Color Stage 3 (3 days after dental bleaching)
The measure of the color was done to the superior canines by just one evaluator. It was done with the Vita Easyshade Spectrophotometer. To improve precision off the data, measures were taken 3 times in all superior canines studied. The Investigators used the values L, C,H.
Time frame: through study completion, an average of 3 days
Change in Color (Stage 3 - Stage 1)
The difference in color was calculated using the international accepted system CIELCh (11,18-19). The formula is ∆E\* = \[(∆L\*)2 + (∆C\*)2 + (∆h\*)2\] ½; were L is Luminosity, C is Chroma and h is Hue. The higher difference in color will show the better intervention.
Time frame: through study completion, an average of 3 days
Change in Color (Stage 2 - Stage 1)
The difference in color was calculated using the international accepted system CIELCh (11,18-19). The formula is ∆E\* = \[(∆L\*)2 + (∆C\*)2 + (∆h\*)2\] ½; were L is Luminosity, C is Chroma and h is Hue. The higher difference in color will show the better intervention.
Time frame: through study completion, an average of 3 days
Immediate Dental Sensitivity
The dental sensitivity was asked 15 minutes after bleaching using a scale: None sensitivity, light sensitivity, moderate sensitivity, severe sensitivity. Less sensitivity is going to be better.
Time frame: through study completion, an average of 3 days
Mediate Dental Sensitivity
The dental sensitivity was asked 3 days after bleaching using a scale: None sensitivity, light sensitivity, moderate sensitivity, severe sensitivity. Less Sensitivity is going to be better.
Time frame: through study completion, an average of 3 days
Plan to share: Yes — By email
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: From the time the protocol is available in clinicaltrials.gov and with no limit of time
Access criteria: Researchers that want to know about the study and use the protocol
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Universidad Nacional de Caaguazu