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The Association of CPP-ACPF Associated With LASER in the Treatment of Tooth Sensitivity After at Home Bleaching

13. dubna 2022 aktualizováno: Cecy Martins Silva, Universidade Federal do Para

Effectiveness of Association of Casein Phosphopeptides-fluoridated Amorphous Calcium Phosphate Associated With Photobiomodulation in the Treatment of Tooth Sensitivity After Home Bleaching: A Randomized, Split-mouth Clinical Trial

Tooth whitening is a procedure that has been increasingly requested by patients around the world, whether at home or in office bleaching. Tooth sensitivity is the main side effect of bleaching. It have a great power to interfere negatively in the quality of life of those affected. According to the literature, about 51% of people who had at-home bleaching developed postoperative sensitivity.

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.

Přehled studie

Postavení

Nábor

Podmínky

Detailní popis

Tooth whitening is a procedure that has been increasingly requested by patients around the world, whether at home or in office bleaching. Tooth sensitivity is the main side effect of bleaching. It have a great power to interfere negatively in the quality of life of those affected. According to the literature, about 51% of people who had at-home bleaching developed postoperative sensitivity.

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.

Typ studie

Intervenční

Zápis (Očekávaný)

50

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

    • PA
      • Belém, PA, Brazílie, 66075-110
        • Zatím nenabíráme
        • Federal University of Para
        • Kontakt:
        • Kontakt:
        • Dílčí vyšetřovatel:
          • Brennda L De Paula, Msc
    • Pará
      • Belém, Pará, Brazílie, 66075-110
        • Nábor
        • Maria Eduarda Cardoso
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 30 let (Dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Age between 18 and 30 years;
  • Good general and oral health;
  • Sound incisors, canines and premolars;
  • Prior whitening treatment;
  • No hypersensitivity;

Exclusion Criteria:

  • Patients undergoing fixed orthodontic treatment;
  • 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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Komparátor placeba: 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.
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.
Ostatní jména:
  • MI paste plus
Žádný zásah: 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
Komparátor placeba: 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.
Apply the laser at three points on each tooth.
Ostatní jména:
  • Therapy EC, DMC
Komparátor placeba: 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.
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.
Ostatní jména:
  • MI paste plus
Apply the laser at three points on each tooth.
Ostatní jména:
  • Therapy EC, DMC

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Sensitivity assessment
Časové okno: Afeter 21 days of tooth whitening
Aplly Repeated Measures ANOVA to analyze tooth sensitivity data reported by patients
Afeter 21 days of tooth whitening

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

20. března 2022

Primární dokončení (Očekávaný)

15. dubna 2022

Dokončení studie (Očekávaný)

22. dubna 2022

Termíny zápisu do studia

První předloženo

17. března 2022

První předloženo, které splnilo kritéria kontroly kvality

25. března 2022

První zveřejněno (Aktuální)

28. března 2022

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

21. dubna 2022

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

13. dubna 2022

Naposledy ověřeno

1. dubna 2022

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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