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Efficacy of an Experimental Gel Based on Libidibia Ferrea on Post-bleaching Tooth Sensitivity

19 maj 2026 uppdaterad 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%.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

75

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Brasilien
    • Pará
      • Belém, Pará, Brasilien, 66075-110
        • UFPA
        • Kontakt:
          • Federal University of Pará
          • Telefonnummer: 55(91) 3201-7390
          • E-post: ppgo@ufpa.br

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: Placebo
The placebo group received an application of placebo gel for the control of post-bleaching tooth sensitivity.
Övrig: Placebo
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.
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.
Övrig: KF2 - Potassium nitrate
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.
Experimentell: Jucá - Libidibia ferrea gel
The Jucá group received an experimental 0.5% Libidibia ferrea gel for the control of post-bleaching tooth sensitivity.
Övrig: Jucá - Libidibia ferrea gel
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Post-whitening sensitivity assessment
Tidsram: 14 days
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.
14 days

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Color evaluation
Tidsram: Baseline (T0) and one week after the second bleaching session (T1)
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).
Baseline (T0) and one week after the second bleaching session (T1)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Universidade Federal do Para

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

13 juni 2026

Primärt slutförande (Beräknad)

30 januari 2027

Avslutad studie (Beräknad)

30 mars 2027

Studieregistreringsdatum

Först inskickad

13 maj 2026

Först inskickad som uppfyllde QC-kriterierna

13 maj 2026

Första postat (Faktisk)

20 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

22 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

19 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 95040526.4.0000.0018

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

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