Bioadhesive Film of Acmella Oleracea (Jambu) in the Reduction of Post-bleaching Dental Sensitivity Caused by Bleaching With 35% Hydrogen Peroxide.

March 13, 2026 updated by: Jesuína Lamartine Nogueira Araújo, Universidade Federal do Para

Application of Acmella Oleracea (Jambu) Bioadhesive Film in Reducing Tooth Sensitivity Induced by Dental Bleaching: a Randomized Clinical Trial.

Despite the wide range of desensitizing agents available on the market, there is still no gold standard treatment that is fully effective in managing sensitivity by dental bleaching. In this context, a bioadhesive film containing Acmella oleracea (jambu)-a natural product with anti-inflammatory and, most notably, analgesic properties-may represent an effective alternative for controlling this discomfort. Therefore, this project aims to clinically evaluate the efficacy of an Acmella oleracea extract bioadhesive film on tooth sensitivity induced by 35% hydrogen peroxide bleaching.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Dental bleaching with hydrogen peroxide (HP) is a frequent treatment in dentistry, but it can present some adverse effects such as alterations in the surface structure of the teeth and tooth sensitivity. This study aimed to evaluate an experimental bioadhesive film of Acmella oleracea (jambu) extract on tooth sensitivity caused by bleaching with 35% hydrogen peroxide and its impact on the participants' oral health-related quality of life (OHRQoL). Seventy-two volunteers were divided into three different groups: GCP - Control group with bioadhesive bioplastic film without spilanthol, GKF - Desensitizing treatment group with 5% potassium nitrate and 2% sodium fluoride (Desensitize KF 2%), and GAO - Group with the experimental bioadhesive film of Acmella oleracea extract. In each group, the corresponding product was applied to the vestibular surfaces of the visible teeth for 10 minutes. Subsequently, all groups underwent an in-office dental bleaching protocol with 35% hydrogen peroxide. Tooth sensitivity was measured using the visual analog scale (VAS), the impact on oral health-related quality of life (OHRQoL) was assessed using the QEDH-15 questionnaire at baseline and at the last sensitivity record, and color measurement was performed at two time points: at baseline and one week after the 3rd bleaching session. Data were subjected to the Shapiro-Wilk normality test. For normally distributed variables, we used repeated measures ANOVA for intragroup analysis and one-way ANOVA for intergroup comparisons, with post-hoc tests when applicable. For non-parametric data, Friedman (intragroup) and Kruskal-Wallis (intergroup) tests were used. Color analysis (ΔE), considering the difference between initial and final times, and the impact on oral health-related quality of life followed the same statistical criteria, according to the data distribution. The significance level adopted was 5% for all analyses. The bioadhesive film is expected to have an effect on nociception and reduce sensitivity caused by bleaching.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Pará
      • Belém, Pará, Brazil, 66075-110
        • Faculdade de Odontologia da Universidade Federal do Pará

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participants must have at least 28 teeth in the cavity
  • good oral and general health

Exclusion Criteria:

  • active caries or periodontal disease
  • visible cracks in front teeth upper or lower
  • with evident malocclusion
  • restorations and prosthetics in teeth anterior teeth
  • gastroesophageal disorders
  • severe internal tooth discoloration (tetracycline , fluorosis or pulped teeth)
  • dentin exposure in anterior teeth and /or later
  • parafunctional habits
  • tooth sensitivity
  • whitening treatment prior to or undergoing orthodontic treatment
  • Furthermore, smokers, pregnant or breastfeeding women do not will be included.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Bioadhesive film of Acmella Oleracea (jambu)
The bioadhesive film of Acmella Oleracea (jambu) will be applied to the vestibular surfaces of the upper and lower central and lateral incisors, canines, and premolars, like a tape, for 10 minutes. Subsequently, all groups will undergo in-office dental whitening treatment with 35% hydrogen peroxide (Whiteness HP, FGM). Sensitivity assessment will be performed using a form composed of a visual analog scale (VAS). Patients will be instructed to record tooth sensitivity daily during the 21-day follow-up period. For color measurement, the VITA Easyshade spectrophotometer (VITA, Germany) will be used at two time points: at baseline (Ti) and one week after the 3rd whitening session (Tf).
Drug: Bioadhesive film of Acmella Oleracea (jambu)
Bioadhesive film of Acmella Oleracea (jambu) for topical application as a tape on teeth prior to teeth whitening with hydrogen peroxide.
Active Comparator: Gel containing 5% potassium nitrate and 2% sodium fluoride
A gel containing 5% potassium nitrate and 2% sodium fluoride (NKFG) will be applied to the buccal surfaces of the upper and lower central and lateral incisors, canines, and premolars using an active microbrush for 10 minutes. Subsequently, all groups will undergo in-office dental whitening treatment with 35% hydrogen peroxide (Whiteness HP, FGM). Sensitivity will be assessed using a visual analog scale (VAS) form. Patients will be instructed to record tooth sensitivity daily during the 21-day follow-up period. For color measurement, the VITA Easyshade spectrophotometer (VITA, Germany) will be used at two time points: at baseline (Ti) and one week after the 3rd whitening session (Tf).
Drug: Gel containing 5% potassium nitrate and 2% sodium fluoride.
Gel containing 5% potassium nitrate and 2% sodium fluoride for topical application to teeth prior to bleaching with hydrogen peroxide.
Placebo Comparator: Spilanthol-free bioadhesive bioplastic film
A spilanthol-free bioadhesive film made of bioplastic will be applied to the buccal surfaces of the upper and lower central and lateral incisors, canines, and premolars, as a tape, actively for 10 minutes. Subsequently, all groups will undergo in-office dental whitening treatment with 35% hydrogen peroxide (Whiteness HP, FGM). Sensitivity will be assessed using a form consisting of a visual analog scale (VAS). Patients will be instructed to record tooth sensitivity daily during the 21-day follow-up period. To measure color, the VITA Easyshade spectrophotometer (VITA, Germany) will be used at two time points: at baseline (Ti) and one week after the 3rd whitening session (Tf).
Other: Spilanthol-free bioadhesive bioplastic film
Spilanthol-free bioadhesive bioplastic film for topical application as a tape on teeth prior to bleaching with hydrogen peroxide.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Degree of tooth sensitivity after teeth whitening with hydrogen peroxide.
Time Frame: immediately after the procedure and during a 21-day treatment period.
The bioadhesive film of Acemella Oleracea (jambu) reduces sensitivity related to teeth whitening with 35% hydrogen peroxide.
immediately after the procedure and during a 21-day treatment period.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in the color of teeth bleached with hydrogen peroxide.
Time Frame: one week after the last whitening session.
Changes in the color of teeth bleached with hydrogen peroxide, even with the application of Acmella Oleracea (jambu) bioadhesive film.
one week after the last whitening session.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Federal do Para

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jesuina L Nogueira Araujo, doutoura, Universidade Federal do Para

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 22, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 2, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 7.589.000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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