The Association of CPP-ACPF Associated With LASER in the Treatment of Tooth Sensitivity After at Home Bleaching
NCT ID: NCT05298059
Last Updated: 2024-12-10
Study Results
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Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2022-03-20
2023-06-20
Brief Summary
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The objective of this clinical, randomized, double-blind study is to evaluate the effectiveness of the association of casein phosphopeptides-fluoridated amorphous calcium phosphate with photobiomodulation in the treatment of tooth sensitivity after home bleaching, with 22% carbamide peroxide and also evaluate the effectiveness of at home bleaching through color analysis.
For develop this study, 50 patients will be selected, with no previous history of sensitivity, aged between 18 and 30 years. They will be divided into four treatment groups: PLACEBO group; CPP-ACPF group; LASER group; LASER+CPP-ACPF group.
Home bleaching treatment will use 22% carbamide peroxide. Patients should use two hours a day for 21 days. The desensitizing treatments will be applied in four moments, according to the group of each patient: before starting the bleaching treatment; after one week of the bleaching treatment; after two weeks of whitening treatment and after three weeks of whitening treatment.
Sensitivity will be assessed using a visual analogue scale (VAS), where patients should daily mark their pain level (from 0 to 10) on each side of the arcade. After the 21 days of treatment, they will receive a new VAS, to evaluate if was any sensitivity will occur during 30 days after the bleaching treatment.
In parallel with bleaching treatment and sensitivity treatment, the color analysis of teeth 13, 11, 21 and 23 will be performed, with the Vita Easyshade Advance 4.0 spectrophotometer, to monitor the bleaching performance, in each week. The first one will occur before starting the bleaching treatment (baseline) and a new measurement will be performed every week, together with the application of treatments for sensitivity.
The collected data will be tabulated in an Excel Microsoft Windows 2010) spreadsheet and analyzed in the Jamovi 1.6.23 (The Jamovi Project, 2020) software. For inter- and intra-group analysis of sensitivity values, the Repeated Measures statistical test will probably be used. For all statistical analyses, a significance level of 5% will be adopted.
Detailed Description
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The objective of this clinical, randomized, double-blind study is to evaluate the effectiveness of the association of casein phosphopeptides-fluoridated amorphous calcium phosphate with photobiomodulation in the treatment of tooth sensitivity after home bleaching, with 22% carbamide peroxide and also evaluate the effectiveness of at home bleaching through color analysis.
Fifty patients will be selected, who will be divided into four treatment groups: PLACEBO group (will receive a LASER simulation and a manipulated paste without active ingredient to simulate the CPP-ACPF paste); CPP-ACPF group (will receive the CPP-ACPF folder and a LASER simulation); LASER group (will receive the LASER and a manipulated paste without active ingredient to simulate the CPP-ACPF paste); LASER+CPP-ACPF group (will receive the LASER and the CPP-ACPF folder). As it is a split-mouth study, each patient will receive two different types of treatment, one on each side of the arches, thus, the sample size of each group will be 25 patients (n=25).
The treatment with the CPP-ACPF paste (MI paste plus) will be carried out in the CPP-ACPF and LASER+CPP-ACPF groups, at the following times: before the bleaching treatment (T0), after one week of bleaching (T1), after two weeks of bleaching (T2), after three weeks of bleaching (T3). The application will be made on the buccal surfaces of the teeth, up to the second premolars, with the aid of a microbrush applicator (Microbrush, 3M Espe), for five minutes. Afterwards, patients will be instructed to spit out the excess and avoid ingesting anything for 30 minutes. In the PLACEBO group, this clinical protocol will be performed exactly, but using the paste without active ingredient.
The LASER and CPP-ACPF+FBM groups will receive the application of LASER (Therapy EC, DMC, São Carlos, SP, Brazil), using the infrared light spectrum with a wavelength of 808 nm with its active medium of Arsento Gallium and Aluminum (AsGaAl), at three points, one in the center of the crown of the tooth, another in the center of the cervical region and the last one in the incisal region, with the light beam directed apically, from all teeth to the second premolar of each hemi -upper and lower arch. The energy used was 1 Joule per point for 10 seconds.
While the PLACEBO and CPP-ACPF groups received a LASER simulation. The sounds emitted by the laser during its use will be simulated by a mobile application.
All study participants will receive a tube of bleaching agent (Whiteness Simple 22%, FGM, Joinville, Brazil) and will be instructed to apply a drop of the product on the vestibular surface of each tooth on the whitening tray (up to the second premolars) and use for two uninterrupted hours for 21 days.
Sensitivity will be assessed using a visual analogue scale (VAS), where patients should daily mark their pain level (from 0 to 10) on each side of the arcade. After the 21 days of treatment, they will receive a new VAS, to evaluate if was any sensitivity will occur during 30 days after the bleaching treatment.
In parallel with bleaching treatment and sensitivity treatment, the color analysis of teeth 13, 11, 21 and 23 will be performed, with the Vita Easyshade Advance 4.0 spectrophotometer, to monitor the bleaching performance, in each week. The first one will occur before starting the bleaching treatment (baseline) and a new measurement will be performed every week, together with the application of treatments for sensitivity.
The collected data will be tabulated in an Excel Microsoft Windows 2010) spreadsheet and analyzed in the Jamovi 1.6.23 (The Jamovi Project, 2020) software. For inter- and intra-group analysis of sensitivity values, the Repeated Measures statistical test will probably be used. For all statistical analyses, a significance level of 5% will be adopted.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
To blind the evaluator of the results, he only had access to the patient's name and sensitivity data, but he did not have access to the group to which the participant belonged.
Study Groups
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CPP-ACPF PASTE APLICATION
Apply the cpp-acpf paste, at four different times (one each week of whitening treatment), for five minutes in each application and evaluate if it was able to reduce the sensitivity after home whitening with 22% carbamide peroxide.
CPP-ACPF
Apply MI paste plus for five minutes, in the vestibular surface os teeth. During this time patientes should be with closed mounth ad should not talk or to split.
Evaluate the effectiviness at home bleaching
To evaluate the effectiveness of at-home bleaching with 22% carbamide peroxide, with the help of the VITA Easyshade 4.0 spectrophotometer
No interventions assigned to this group
LASER APLICATION
Apply the laser at four different times (one every week of whitening treatment), using the spectrum of infrared light with a wavelength of 808 nm with its active medium of Arsento Gallium and Aluminum (AsGaAl), at three points, one in the center of the crown of the tooth, another in the center of the cervical region and the last one in the incisal region, with the light beam directed apically, from all teeth to the second premolar of each upper and lower hemi-arch, with energy of of 1 Joule per point for 10 seconds. and evaluate if it was able to reduce the sensitivity after home whitening with 22% carbamide peroxide.
Laser of low frequncy
Apply the laser at three points on each tooth.
Associate the CPP-ACPF paste with the LASER
Associate the CPP-ACPF paste with the LASER, following the same clinical protocol mentioned above and assess whether the association is more efficient than both treatments alone.
Laser of low frequncy
Apply the laser at three points on each tooth.
CPP-ACPF
Apply MI paste plus for five minutes, in the vestibular surface os teeth. During this time patientes should be with closed mounth ad should not talk or to split.
Interventions
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Laser of low frequncy
Apply the laser at three points on each tooth.
CPP-ACPF
Apply MI paste plus for five minutes, in the vestibular surface os teeth. During this time patientes should be with closed mounth ad should not talk or to split.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Good general and oral health;
* Sound incisors, canines and premolars;
* Prior whitening treatment;
* No hypersensitivity;
Exclusion Criteria
* Presence of periodontal disease;
* Presence of cracks or fractures;
* Presence of restorations and prostheses in anterior teeth;
* Extensive restorations in molars;
* Presence of gastroesophageal dysfunctions;
* Patients with severe internal dental darkening;
* Presence of exposed dentin.
18 Years
30 Years
ALL
Yes
Sponsors
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Universidade Federal do Para
OTHER
Responsible Party
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Cecy Martins Silva
Clinical professor
Locations
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Federal University of Pará
Belém, Pará, Brazil
Maria Eduarda Cardoso
Belém, Pará, Brazil
Countries
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References
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Guanipa Ortiz MI, Alencar CM, Freitas De Paula BL, Alves EB, Nogueira Araujo JL, Silva CM. Effect of the casein phosphopeptide-amorphous calcium phosphate fluoride (CPP-ACPF) and photobiomodulation (PBM) on dental hypersensitivity: A randomized controlled clinical trial. PLoS One. 2019 Dec 2;14(12):e0225501. doi: 10.1371/journal.pone.0225501. eCollection 2019.
Dahl JE, Pallesen U. Tooth bleaching--a critical review of the biological aspects. Crit Rev Oral Biol Med. 2003;14(4):292-304. doi: 10.1177/154411130301400406.
Pontes M, Gomes J, Lemos C, Leao RS, Moraes S, Vasconcelos B, Pellizzer EP. Effect of Bleaching Gel Concentration on Tooth Color and Sensitivity: A Systematic Review and Meta-analysis. Oper Dent. 2020 May/Jun;45(3):265-275. doi: 10.2341/17-376-L.
de Vasconcelos AA, Cunha AG, Borges BC, Machado CT, dos Santos AJ. Tooth whitening with hydrogen/carbamide peroxides in association with a CPP-ACP paste at different proportions. Aust Dent J. 2012 Jun;57(2):213-9. doi: 10.1111/j.1834-7819.2012.01683.x. Epub 2012 Apr 4.
Huq NL, Myroforidis H, Cross KJ, Stanton DP, Veith PD, Ward BR, Reynolds EC. The Interactions of CPP-ACP with Saliva. Int J Mol Sci. 2016 Jun 9;17(6):915. doi: 10.3390/ijms17060915.
Szesz A, Parreiras S, Martini E, Reis A, Loguercio A. Effect of flowable composites on the clinical performance of non-carious cervical lesions: A systematic review and meta-analysis. J Dent. 2017 Oct;65:11-21. doi: 10.1016/j.jdent.2017.07.007. Epub 2017 Jul 17.
Chidchuangchai W, Vongsavan N, Matthews B. Sensory transduction mechanisms responsible for pain caused by cold stimulation of dentine in man. Arch Oral Biol. 2007 Feb;52(2):154-60. doi: 10.1016/j.archoralbio.2006.09.009. Epub 2006 Nov 15.
Splieth CH, Tachou A. Epidemiology of dentin hypersensitivity. Clin Oral Investig. 2013 Mar;17 Suppl 1(Suppl 1):S3-8. doi: 10.1007/s00784-012-0889-8. Epub 2012 Dec 7.
Pompeu DDS, de Paula BLF, Barros APO, Nunes SC, Carneiro AMP, Araujo JLN, Silva CM. Combination of strontium chloride and photobiomodulation in the control of tooth sensitivity post-bleaching: A split-mouth randomized clinical trial. PLoS One. 2021 Apr 28;16(4):e0250501. doi: 10.1371/journal.pone.0250501. eCollection 2021.
Sasaki RT, Arcanjo AJ, Florio FM, Basting RT. Micromorphology and microhardness of enamel after treatment with home-use bleaching agents containing 10% carbamide peroxide and 7.5% hydrogen peroxide. J Appl Oral Sci. 2009 Nov-Dec;17(6):611-6. doi: 10.1590/s1678-77572009000600014.
Hosseinpour S, Tuner J, Fekrazad R. Photobiomodulation in Oral Surgery: A Review. Photobiomodul Photomed Laser Surg. 2019 Dec;37(12):814-825. doi: 10.1089/photob.2019.4712. Epub 2019 Nov 21.
Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. PLoS Med. 2010 Mar 24;7(3):e1000251. doi: 10.1371/journal.pmed.1000251.
Gerritsen AE, Allen PF, Witter DJ, Bronkhorst EM, Creugers NH. Tooth loss and oral health-related quality of life: a systematic review and meta-analysis. Health Qual Life Outcomes. 2010 Nov 5;8:126. doi: 10.1186/1477-7525-8-126.
Sulieman M, Addy M, MacDonald E, Rees JS. The effect of hydrogen peroxide concentration on the outcome of tooth whitening: an in vitro study. J Dent. 2004 May;32(4):295-9. doi: 10.1016/j.jdent.2004.01.003.
Kielbassa AM, Maier M, Gieren AK, Eliav E. Tooth sensitivity during and after vital tooth bleaching: A systematic review on an unsolved problem. Quintessence Int. 2015 Nov-Dec;46(10):881-97. doi: 10.3290/j.qi.a34700.
Moosavi H, Arjmand N, Ahrari F, Zakeri M, Maleknejad F. Effect of low-level laser therapy on tooth sensitivity induced by in-office bleaching. Lasers Med Sci. 2016 May;31(4):713-9. doi: 10.1007/s10103-016-1913-z. Epub 2016 Mar 10.
Rezende M, Loguercio AD, Kossatz S, Reis A. Predictive factors on the efficacy and risk/intensity of tooth sensitivity of dental bleaching: A multi regression and logistic analysis. J Dent. 2016 Feb;45:1-6. doi: 10.1016/j.jdent.2015.11.003. Epub 2015 Dec 2.
Gojkov-Vukelic M, Hadzic S, Zukanovic A, Pasic E, Pavlic V. Application of Diode Laser in the Treatment of Dentine Hypersensitivity. Med Arch. 2016 Dec;70(6):466-469. doi: 10.5455/medarh.2016.70.466-469.
Other Identifiers
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UFPara05
Identifier Type: -
Identifier Source: org_study_id