Tooth DiscolorationNCT03688893
Efficacy of Laser Application in Dental Bleaching
A study testing Laser Application for Dental Bleaching in people with Tooth Discoloration, run by Universidad Nacional de Caaguazu at 1 site in Paraguay.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Discoloration
- What is being tested?
- Laser Application for Dental Bleaching
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteParaguay
- Study dates
- 5 Sep 2015to 25 Sep 2015
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who wanted to bleach or whiten their teeth.
Who cannot join
- Patients who have a color less than A2 according to the Vita Scale
- Patients with dental sensitivity
- caries or restorations
- periodontal disease
- dental abfraction or attrition
- pregnant women, smokers
Show all 9Show fewer
- patients with orthodontics
- nauseous reflects
- patients who did not wish to sign the consent.
Trial locations and contacts
1 site in 1 country.
Paraguay1 site
Facultad de Odontología Universidad Nacional de Caaguazú
Coronel Oviedo, International, 595
About this study
Official title: Efficacy of Laser Application in Dental Bleaching: A Randomized Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Tooth Discoloration
- Being tested
- Laser Application for Dental Bleaching
- Keywords
- Bleaching, Laser, CIELCH
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Application for Dental BleachingDevice
The Laser used was the Whitening Lase II (DCM EQUIPMENTS).
| Study group | Role | What they receive |
|---|---|---|
| Laser Application | Experimental | 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 Receives: Device: Laser Application for Dental Bleaching |
| No Laser Application | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 3 days
Secondary outcomes (2)
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.
Measured: 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.
Measured: through study completion, an average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start5 Sep 2015
- Primary completion22 Sep 2015
- Study completion25 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Tooth DiscolorationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators conducted a Randomized controlled trial (RCT) to study the effect of LASER in dental bleaching in 24 patients in Paraguay in 2015.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Caaguazu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julieta María Méndez Romero, Universidad Nacional de Caaguazu
- Investigators
- Julieta M Méndez, DDs, Principal investigator, Facultad de Odontología Universidad Nacional de CaaguazúUlises A Villasanti Torales, DDs, Mgst, Study director, Facultad de Odontología Universidad Nacional de Caaguazú
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03688893
- Sponsor's protocol ID
- U1111-1219-0122
- Status last verified
- Oct 2018
- First submitted
- 21 Sep 2018
- Last updated
- 19 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: By email
Publications
González Rosino B. Estudio clínico comparativo entre dos dispositivos de luz para blanqueamientos en clínica. 2014; [citado 17 de julio 2015]. Disponible en: http://eprints.ucm.es/27417/
Giannini M, Hirata R, Coelho AS, de Oliveira VAP, Chan DCN. Agentes Blanqueadores y Técnicas Utilizadas en Consultorio. ROBYD [Internet]. 2013 enero-abril;II(1). [citado 22 de julio 2015]. Disponible en: www.rodyb.com/agentes---blanqueadores---y---tecnicas---utilizadas---en--consultorio---27/
Henry RK, Bauchmoyer SM, Moore W, Rashid RG. The effect of light on tooth whitening: a split-mouth design. Int J Dent Hyg. 2013 May;11(2):151-4. doi: 10.1111/j.1601-5037.2012.00568.x. Epub 2012 Jul 12.
PubMed 22783981Dostalova T, Jelinkova H, Housova D, Sulc J, Nemec M, Miyagi M, et al. Diode laser-activatedbleaching. BrazDent J. 2004;15(Special Issue):3-8. [citado 27 de marzo 2016]. Disponible en: http://blackstar.forp.usp.br/bdj/bdj15si/pdf/v15sia01.pdf
Wetter NU, Walverde D, Kato IT, Eduardo Cde P. Bleaching efficacy of whitening agents activated by xenon lamp and 960-nm diode radiation. Photomed Laser Surg. 2004 Dec;22(6):489-93. doi: 10.1089/pho.2004.22.489.
PubMed 15684748Alomari Q, El Daraa E. A randomized clinical trial of in-office dental bleaching with or without light activation. J Contemp Dent Pract. 2010 Jan 1;11(1):E017-24.
PubMed 20098962
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Laser Application in Dental Bleaching: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03688893
- Acronym / sponsor ID
- U1111-1219-0122
- Conditions
- Tooth Discoloration
- Keywords
- Bleaching, Laser, CIELCH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universidad Nacional de CaaguazuUniversity, hospital or other
- Study start
- 5 Sep 2015 (actual)
- Primary completion
- 22 Sep 2015 (actual)
- Study completion
- 25 Sep 2015 (actual)
- First posted
- 28 Sep 2018 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The investigators conducted a Randomized controlled trial (RCT) to study the effect of LASER in dental bleaching in 24 patients in Paraguay in 2015.
| Arm | Type | Receives |
|---|---|---|
| Laser Application | Experimental | Device: Laser Application for Dental Bleaching35% 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 |
| No Laser Application | No intervention | –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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients who wanted to bleach or whiten their teeth.
Key exclusion criteria (9 listed)
- Patients who have a color less than A2 according to the Vita Scale
- Patients with dental sensitivity
- caries or restorations
- periodontal disease
- dental abfraction or attrition
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 |
|---|---|---|
| Laser Application for Dental BleachingThe Laser used was the Whitening Lase II (DCM EQUIPMENTS). | Device | Laser Application |
Primary outcome
Dental Color Stage 1(Before Intervention)
Time frame: through study completion, an average of 3 days
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.
Dental Color Stage 2 (30 minutes after dental bleaching)
Time frame: through study completion, an average of 3 days
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.
Dental Color Stage 3 (3 days after dental bleaching)
Time frame: through study completion, an average of 3 days
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.
Change in Color (Stage 3 - Stage 1)
Time frame: through study completion, an average of 3 days
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.
Change in Color (Stage 2 - Stage 1)
Time frame: through study completion, an average of 3 days
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.
2 secondary outcomes
Immediate Dental Sensitivity
Time frame: through study completion, an average of 3 days
Mediate Dental Sensitivity
Time frame: through study completion, an average of 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2018.
- BackgroundGonzález Rosino B. Estudio clínico comparativo entre dos dispositivos de luz para blanqueamientos en clínica. 2014; [citado 17 de julio 2015]. Disponible en: http://eprints.ucm.es/27417/
- BackgroundGiannini M, Hirata R, Coelho AS, de Oliveira VAP, Chan DCN. Agentes Blanqueadores y Técnicas Utilizadas en Consultorio. ROBYD [Internet]. 2013 enero-abril;II(1). [citado 22 de julio 2015]. Disponible en: www.rodyb.com/agentes---blanqueadores---y---tecnicas---utilizadas---en--consultorio---27/
- Background: PubMed 22783981Henry RK, Bauchmoyer SM, Moore W, Rashid RG. The effect of light on tooth whitening: a split-mouth design. Int J Dent Hyg. 2013 May;11(2):151-4. doi: 10.1111/j.1601-5037.2012.00568.x. Epub 2012 Jul 12.
- BackgroundDostalova T, Jelinkova H, Housova D, Sulc J, Nemec M, Miyagi M, et al. Diode laser-activatedbleaching. BrazDent J. 2004;15(Special Issue):3-8. [citado 27 de marzo 2016]. Disponible en: http://blackstar.forp.usp.br/bdj/bdj15si/pdf/v15sia01.pdf
- Background: PubMed 15684748Wetter NU, Walverde D, Kato IT, Eduardo Cde P. Bleaching efficacy of whitening agents activated by xenon lamp and 960-nm diode radiation. Photomed Laser Surg. 2004 Dec;22(6):489-93. doi: 10.1089/pho.2004.22.489.
- Background: PubMed 20098962Alomari Q, El Daraa E. A randomized clinical trial of in-office dental bleaching with or without light activation. J Contemp Dent Pract. 2010 Jan 1;11(1):E017-24.
- Individual participant dataSharing planned: Yes. By email
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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.
Julieta M Méndez, DDs principal investigator
Facultad de Odontología Universidad Nacional de Caaguazú
Ulises A Villasanti Torales, DDs, Mgst study director
Facultad de Odontología Universidad Nacional de Caaguazú
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Application for Dental Bleaching in people with Tooth Discoloration, run by Universidad Nacional de Caaguazu at 1 site in Paraguay.
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 1 inclusion and 9 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: finished, as of the sponsor's last update on 19 Oct 2018. 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 Paraguay. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental Color Stage 1(Before Intervention) (time frame: through study completion, an average of 3 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03688893, which also lists 6 linked publications.
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 19 Oct 2018.