Efficacy of an Experimental Gel Based on Libidibia Ferrea on Post-bleaching Tooth Sensitivity
19. mai 2026 oppdatert av: Cecy Martins Silva, Universidade Federal do Para
Efficacy of an Experimental Gel Based on Libidibia Ferrea in Controlling Post-bleaching Tooth Sensitivity: a Randomized Clinical Trial.
This randomized, parallel, single-blind, placebo-controlled clinical trial aims to investigate the effects of an experimental 0.5% Libidibia ferrea gel on the control of post-bleaching tooth sensitivity and its influence on bleaching efficacy.
Seventy-five selected volunteers will be randomly allocated into three groups: CT (placebo gel), KF2 (5% potassium nitrate and 2% sodium fluoride), and JUC (experimental Libidibia ferrea gel).
Each group will receive the corresponding desensitizing treatment, and the assigned product will be actively applied to the labial surfaces of the anterior teeth and the buccal surfaces of the first premolars for 10 minutes.
Subsequently, all groups will undergo an in-office tooth bleaching protocol with 35% hydrogen peroxide, consisting of two sessions with three 15-minute applications each, with a 7-day interval between sessions.
Postoperative sensitivity will be recorded daily by the patients for 14 days using a visual analog scale (VAS), while tooth color will be measured using a spectrophotometer at baseline and one week after the end of treatment.
Data will be subjected to statistical analysis according to sample distribution, with a statistical power of 80% and a significance level of 5%.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Detaljert beskrivelse
All groups will undergo in-office tooth bleaching treatment, performed in two sessions with a 7-day interval, according to the steps described below: prophylaxis; application of the desensitizing agent or placebo, according to the assigned group, for 10 minutes; rinsing with water; application of the gingival barrier; application of Whiteness HP 35% bleaching gel for 45 minutes, consisting of three 15-minute applications; final removal of the bleaching gel and gingival barrier, followed by rinsing with water.
A lip retractor will be used during the application of the desensitizing agent or placebo and throughout the bleaching procedure.
The assigned product will be actively applied using a microbrush.
Studietype
Intervensjonell
Registrering (Antatt)
75
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Cecy M Silva
- Telefonnummer: +55 (91) 3201-7563
- E-post: cecymsilva@gmail.com
Studiesteder
-
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Pará
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Belém, Pará, Brasil, 66075-110
- UFPA
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Ta kontakt med:
- Federal University of Pará
- Telefonnummer: 55(91) 3201-7390
- E-post: ppgo@ufpa.br
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
Good oral hygiene; Absence of active caries lesions; No previous tooth bleaching treatment; Absence of dental hypersensitivity; Not being pregnant; Presence of at least 28 teeth in the oral cavity.
Exclusion Criteria:
Volunteers undergoing orthodontic treatment; Presence of periodontal disease; Dental cracks or fractures; Restorations or prostheses on anterior teeth; Extensive restorations in molars; Gastroesophageal disorders; Severe intrinsic tooth discoloration; Presence of dentin exposure in anterior and/or posterior teeth.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Placebo komparator: Placebo
The placebo group received an application of placebo gel for the control of post-bleaching tooth sensitivity.
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Before bleaching treatment with 35% hydrogen peroxide, participants in the placebo group received a placebo gel without active ingredients, applied under the same conditions described for the experimental gel.
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Aktiv komparator: KF2 - Potassium nitrate
The KF2 group received an application of 5% potassium nitrate and 2% sodium fluoride for the control of post-bleaching tooth sensitivity.
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Prior to bleaching treatment with 35% hydrogen peroxide, participants in the KF2 group will receive an application of a desensitizing gel containing 5% potassium nitrate and 2% sodium fluoride on the labial surfaces of the maxillary and mandibular central incisors, lateral incisors, and canines, and on the buccal surfaces of the maxillary and mandibular premolars, for 10 minutes.
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Eksperimentell: Jucá - Libidibia ferrea gel
The Jucá group received an experimental 0.5% Libidibia ferrea gel for the control of post-bleaching tooth sensitivity.
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Prior to bleaching treatment with 35% hydrogen peroxide, participants in the Jucá group will receive an application of the experimental 0.5% Libidibia ferrea gel on the labial surfaces of the maxillary and mandibular central incisors, lateral incisors, and canines, and on the buccal surfaces of the maxillary and mandibular premolars, for 10 minutes.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Post-whitening sensitivity assessment
Tidsramme: 14 days
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To assess postoperative sensitivity, patients will be instructed to complete a form to record daily tooth sensitivity during the 14-day treatment period, based on their individual perception of pain.
This form will be provided at each bleaching session and returned to the researcher at the following session, that is, one week after each bleaching session.
The assessment form will include a visual analog scale (VAS), consisting of a 10-cm horizontal line with scores of 0 and 10 at its ends, where 0 indicates no sensitivity and 10 indicates severe tooth sensitivity.
Patients will be instructed to draw a vertical mark along the horizontal line of the scale to record the intensity of tooth sensitivity each day.
Subsequently, the distance in millimeters from the zero endpoint will be measured using a millimeter ruler, thereby obtaining the patient's pain intensity score.
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14 days
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Color evaluation
Tidsramme: Baseline (T0) and one week after the second bleaching session (T1)
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The VITA Easyshade spectrophotometer (VITA Zahnfabrik, Bad Säckingen, Germany) will be used for color measurement.
The evaluated tooth area will be the middle third of the labial surface of the maxillary canines.
To standardize color readings, silicone matrices will be fabricated, with the impression extending from canine to canine.
A window will be created on the labial surface of each canine in the silicone guide using a metal device with a 6-mm diameter, corresponding to the diameter of the spectrophotometer tip.
Thus, the tip of the device will be inserted into the silicone guide to obtain the color parameters.
Subsequently, the color difference between baseline (T0) and one week after the second bleaching session (T1) will be calculated using the CIEDE2000 formula (ΔE00).
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Baseline (T0) and one week after the second bleaching session (T1)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
13. juni 2026
Primær fullføring (Antatt)
30. januar 2027
Studiet fullført (Antatt)
30. mars 2027
Datoer for studieregistrering
Først innsendt
13. mai 2026
Først innsendt som oppfylte QC-kriteriene
13. mai 2026
Først lagt ut (Faktiske)
20. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 95040526.4.0000.0018
Plan for individuelle deltakerdata (IPD)
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NEI
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