Effects of an Experimental Propolis Gel on Tooth Sensitivity Control and Post-bleaching Color Change: a Randomized Clinical Trial
29 april 2026 bijgewerkt door: Cecy Martins Silva, Universidade Federal do Para
Effects of a 0.5% Experimental Propolis Gel on Tooth Sensitivity Control and Post-bleaching Color Change: a Randomized Clinical Trial
This randomized, parallel, double-blind, placebo-controlled clinical study aims to investigate the effects of an experimental 0.5% propolis gel on controlling tooth sensitivity and discoloration after in-office dental bleaching.
Sixty-six volunteers will be selected according to inclusion and exclusion criteria and will be randomly assigned to three experimental groups: Placebo - received application of a gel without active ingredient (K-Y Original), KF2 - received application of 5% potassium nitrate and 2% sodium fluoride (Desensitize KF 2%), and Propolis 0.5% - application of the experimental 0.5% propolis gel.
All participants will undergo two in-office bleaching sessions with 35% hydrogen peroxide, with seven-day intervals between them.
The bleaching agent will be applied for 30 minutes.
The desensitizing agents will be applied prior to bleaching and kept in contact with the vestibular dental surface for ten minutes.
Sensitivity will be monitored daily using the Visual Analogue Scale for fourteen days, while color change will be determined by spectrophotometry, using the parameters of the CIELab* system and calculation of ΔE00, measured before bleaching (T0) and 7 days after the second bleaching session (T1).
The data will be subjected to statistical analysis according to sample distribution, adopting a power of 80% and a significance level of 5%.
Studie Overzicht
Toestand
Nog niet aan het werven
Interventie / Behandeling
Gedetailleerde beschrijving
All groups will undergo in-office whitening treatment, carried out in 2 sessions with a 7-day interval, according to the steps described below:
Prophylaxis; Application of gingival barrier; Application of desensitizing agent or placebo, according to the established groups; Handling of the whitening material following the manufacturer's instructions: application of Whiteness HP 35% whitening gel for 30 minutes Final removal of the whitening gel and gingival barrier, followed by rinsing with water.
The application of the desensitizing agent or its placebo will follow this sequence:
Relative isolation with cotton rolls; Active application of the product on the buccal surfaces of all teeth using a rubber cup for 10 minutes; Rinsing with water.
Studietype
Ingrijpend
Inschrijving (Geschat)
66
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Cecy M Silva, Doctor
- Telefoonnummer: +55 (91) 3201-7563
- E-mail: cecymsilva@gmail.com
Studie Locaties
-
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Pará
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Belém, Pará, Brazilië, 66075-110
- UFPA
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Contact:
- University F Para
- Telefoonnummer: 55(91) 3201-7390
- E-mail: ppgo@ufpa.br
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-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
- good oral hygiene
- absence of active caries lesions
- never having previous whitening therapy
- not present dental hypersensitivity
- don't be a smoker
- not be pregnant
- present at least 28 teeth in the oral cavity.
Exclusion Criteria:
- volunteers who were under orthodontic treatment,
- presence of periodontal disease
- dental cracks or fractures
- restorations and prostheses on anterior teeth
- extensive molar restorations
- gastroesophageal disorders
- severe internal dental darkening
- presence of dentinal exposure in anterior and/or posterior teeth.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Placebo-vergelijker: Placebo- KY original gel
The Placebo group received the application of placebo gel for post tooth bleaching sensitivity.
|
Prior to bleaching treatment with 35% hydrogen peroxide, the Placebo group received the application of a placebo gel (without active ingredient), under the same conditions described for the experimental gel.
|
|
Actieve vergelijker: KF2- Potassium nitrate
The KF2 group received the application of potassium nitrate for post tooth bleaching sensitivity.
|
Prior to bleaching treatment with 35% hydrogen peroxide, the dental elements of the KF2 received application of the potassium nitrate gel on the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, for 10 minutes.
|
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Experimenteel: Propolis- Propolis 0,5% gel
The Propolis group received the application of experimental gel of propolis 0,5% for post tooth bleaching sensitivity.
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Prior to bleaching treatment with 35% hydrogen peroxide, the dental elements of the Propolis received application of the experimental desensitizing gel on the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, for 10 minutes.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Post-whitening sensitivity assessment
Tijdsspanne: 14 days
|
To assess post-operative sensitivity, patients will be instructed to fill out a form to record daily tooth sensitivity during the 14 days of treatment, based on their individual perception of pain.
This form will be handed out at each whitening session and returned to the researcher at the following session, that is, always one week after each whitening session.
The assessment form will consist of a visual analogue scale (VAS).
This scale consists of a 10 cm horizontal line with scores of 0 and 10 at its ends, where 0 means no sensitivity and 10 means severe tooth sensitivity.
The patient will be instructed to draw a vertical line along the horizontal line of the scale, recording the intensity of tooth sensitivity per day.
So that the distance in millimeters from the zero end can later be measured with the aid of a millimeter ruler, thus obtaining the patient's pain intensity level.
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14 days
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Color evaluation
Tijdsspanne: Baseline (T0) and one week after the 2rd whitening session (T1)
|
The VITA Easyshade spectrophotometer (VITA Zahnfabrik, Bad Säckingen, Germany) will be used to measure the color, where the area of dental correspondence to be evaluated will be the middle third of the vestibular surface of the upper canines.
To standardize the color readings, silicone matrices will be made, where the impression will be extended from canine to canine.
A window will be created on the vestibular surface of each canine of the silicone guide using a metal device with a radius of 6 mm, 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 the baseline (T0) and one week after the 2rd bleaching session (T1) will be calculated using the CIEDE2000 formulas (ΔE00).
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Baseline (T0) and one week after the 2rd whitening session (T1)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
29 april 2026
Primaire voltooiing (Geschat)
30 december 2026
Studie voltooiing (Geschat)
30 maart 2027
Studieregistratiedata
Eerst ingediend
29 april 2026
Eerst ingediend dat voldeed aan de QC-criteria
29 april 2026
Eerst geplaatst (Werkelijk)
6 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
6 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
29 april 2026
Laatst geverifieerd
1 april 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 93881125.4.0000.0018
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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